Jupiter030033.com

CurrentlyClearedCBER510(k)sbyApplicantAsof28‐FEB‐2021BK980025‐05DInformationManagementSuite500,10025‐102AAvenueEdmonton,AlbertaCANADAT5J2Z2TradeName:PlasmaCenterModule‐1.
0ClearedDate:18‐MAY‐1999ClearedUnderFifthDimensionInformationSystemsBK990022‐05DInformationManagementSuite500,10025‐102AAvenueEdmonton,AlbertaCANADAT5J2Z2TradeName:DonorManagementSystem‐1.
0.
0ClearedDate:10‐SEP‐1999ClearedUnderFifthDimensionInformationSystemsBK000026‐05DInformationManagementSuite500,10025‐102AAvenueEdmonton,AlbertaCANADAT5J2Z2TradeName:P2KPlasmaCenterModule2000‐1.
0ClearedDate:22‐JUN‐2000ClearedUnderFifthDimensionInformationSystemsBK020058‐05DInformationManagementSuite500,10025‐102AAvenueEdmonton,AlbertaCANADAT5J2Z2TradeName:LOGIC‐1.
0ClearedDate:03‐FEB‐2003ClearedUnderFifthDimensionInformationSystemsBK040040‐05DInformationManagementSuite500,10025‐102AAvenueEdmonton,AlbertaCANADAT5J2Z2TradeName:LOGIC‐2.
0ClearedDate:06‐OCT‐2004ClearedUnderFifthDimensionInformationSystemsBK050060‐05DInformationManagementSuite500,10025‐102AAvenueEdmonton,AlbertaCANADAT5J2Z2TradeName:E‐Interview(eQue)‐1.
0.
0ClearedDate:24‐MAY‐2006ClearedUnderFifthDimensionInformationSystemsBK060051‐05DInformationManagementSuite500,10025‐102AAvenueEdmonton,AlbertaCANADAT5J2Z2TradeName:HaemoConnect(eLynx)‐1.
0.
0ClearedDate:06‐MAR‐2008BK070011‐0ABSORBERABDrottninggatan33Stockholm,SWEDENSE‐10395TradeName:XM‐ONETransplantationCrossMatchClearedDate:29‐JUL‐2008BK960027‐0ADACHealthCareInformationSystem5GreenwayPlazaSuite1900Houston,TX77046TradeName:ADACBloodBankSystemClearedDate:12‐AUG‐1998BK050005‐0ALBABioscienceLimited(doingbusinessasQuotient)21Ellen'sGlenRoadLiberton,EdinburghEH177QTScotland,UNITEDKINGDOM,UNITEDKINGDOMEH177QTTradeName:Quant‐RhoFITCAnti‐DforFetalCellAssayClearedDate:27‐SEP‐2005ClearedUnderALBABioscienceBK070033‐0ALBABioscienceLimited(doingbusinessasQuotient)21Ellen'sGlenRoadLiberton,EdinburghEH177QTScotland,UNITEDKINGDOM,UNITEDKINGDOMEH177QTTradeName:AlbaQ‐ChekSimulatedWholeBloodControlsClearedDate:27‐JUL‐2007ClearedUnderALBABioscienceBK080027‐0ALBABioscienceLimited(doingbusinessasQuotient)21Ellen'sGlenRoadLiberton,EdinburghEH177QTScotland,UNITEDKINGDOM,UNITEDKINGDOMEH177QTTradeName:ALBAcheck‐BGSReagentControlforAnti‐DClearedDate:29‐JUL‐2008ClearedUnderALBABioscienceBK080051‐0ALBABioscienceLimited(doingbusinessasQuotient)21Ellen'sGlenRoadLiberton,EdinburghEH177QTScotland,UNITEDKINGDOM,UNITEDKINGDOMEH177QTTradeName:FETALSCREENClearedDate:08‐APR‐2009ClearedUnderALBABioscienceBK090030‐0ALBABioscienceLimited(doingbusinessasQuotient)21Ellen'sGlenRoadLiberton,EdinburghEH177QTScotland,UNITEDKINGDOM,UNITEDKINGDOMEH177QTTradeName:ALBAcheck‐BGSWholeBloodControls‐SPClearedDate:14‐JUN‐2010ClearedUnderALBABioscienceBK100005‐0ALBABioscienceLimited(doingbusinessasQuotient)21Ellen'sGlenRoadLiberton,EdinburghEH177QTScotland,UNITEDKINGDOM,UNITEDKINGDOMEH177QTTradeName:ALBAcyteIgGSensitizedRedBloodCellsClearedDate:26‐AUG‐2010ClearedUnderALBABioscienceBK140144‐0ALBABioscienceLimited(doingbusinessasQuotient)21Ellen'sGlenRoadLiberton,EdinburghEH177QTScotland,UNITEDKINGDOM,UNITEDKINGDOMEH177QTTradeName:ALBAzyme(TM)PapainSolutionKitClearedDate:17‐SEP‐2014BK140208‐0ALBABioscienceLimited(doingbusinessasQuotient)21Ellen'sGlenRoadLiberton,EdinburghEH177QTScotland,UNITEDKINGDOM,UNITEDKINGDOMEH177QTTradeName:ALBAcyteC3CoatedRedBloodCellsClearedDate:04‐MAR‐2015BK150217‐0ALBABioscienceLimited(doingbusinessasQuotient)21Ellen'sGlenRoadLiberton,EdinburghEH177QTScotland,UNITEDKINGDOM,UNITEDKINGDOMEH177QTTradeName:ALBAsureQCKitClearedDate:01‐APR‐2015BK150246‐0ALBABioscienceLimited(doingbusinessasQuotient)21Ellen'sGlenRoadLiberton,EdinburghEH177QTScotland,UNITEDKINGDOM,UNITEDKINGDOMEH177QTTradeName:ORTHO(TM)SeraPapainClearedDate:20‐OCT‐2015BK180252‐0APEXBiologix5650SouthGreenStMurray,UT84123TradeName:XCELLPRPPlateletConcentratingSystem60mlClearedDate:05‐APR‐2019BK870009‐0ARK‐Bio‐MedicalCanadaCorp.
#671RusticoRoadWinsloe,CANADACIE1Z2TradeName:WesLabsModel601ClearedDate:15‐NOV‐1989ClearedUnderRushEnterprises,Inc.
BK900012‐0AbbottLaboratories100AbbottParkRoadAbbottPark,IL60064‐3500TradeName:AbbottAnti‐HBsPanelClearedDate:11‐OCT‐1990BK950046‐0AbbottLaboratories100AbbottParkRoadAbbottPark,IL60064‐3500TradeName:AbbottCMVTotalABEIAClearedDate:22‐DEC‐1995BK950048‐0AbbottLaboratories100AbbottParkRoadAbbottPark,IL60064‐3500TradeName:AbbottApheresisResultsTrackingSystem/AARTSClearedDate:24‐JUN‐1998BK950052‐0AbbottLaboratories100AbbottParkRoadAbbottPark,IL60064‐3500TradeName:AbbottDMSIIDataManagementSystemClearedDate:12‐AUG‐1998BK970042‐0AbbottLaboratories100AbbottParkRoadAbbottPark,IL60064‐3500TradeName:ABBOTTPRISMSystemClearedDate:14‐JUN‐1999BK010036‐0AbbottLaboratories100AbbottParkRoadAbbottPark,IL60064‐3500TradeName:ABBOTTPRISMRetestServer‐1.
0ClearedDate:17‐JUL‐2002BK060028‐0AbbottLaboratories100AbbottParkRoadAbbottPark,IL60064‐3500TradeName:AbbottPRISMRetestServerClearedDate:07‐JUN‐2006BK080015‐0AbbottLaboratories100AbbottParkRoadAbbottPark,IL60064‐3500TradeName:ABBOTTPRISMDirectorV2.
0ClearedDate:24‐APR‐2008BK130020‐0AbbottLaboratoriesDept09VA,BldgAP8‐1100AbbottParkRoadAbbottPark,IL60064‐3500TradeName:ABBOTTPRISMDirectorClearedDate:14‐MAY‐2013BK810599‐0Accugenics,Inc.
CostaMesa,CA92626TradeName:DadeRhControlReagentClearedDate:31‐MAR‐1981BK820004‐0Accugenics,Inc.
CostaMesa,CA92626TradeName:Trans‐TypeReagentsClearedDate:29‐OCT‐1982BK830001‐0Accugenics,Inc.
CostaMesa,CA92626TradeName:PolycationPotentiatorSystemClearedDate:06‐MAY‐1983BK860038‐0Accugenics,Inc.
CostaMesa,CA92626TradeName:Data‐FiThrombinReagentClearedDate:16‐JAN‐1987BK890018‐0AckradLaboratories70JacksonDr.
Cranford,NJ07016TradeName:AckradBloodWarmingAssemblyClearedDate:21‐SEP‐1990BK960071‐0AcroMetrixCorporation6058EgretCourtBenicia,CA94510TradeName:ViroSureMulti‐MarkerClearedDate:11‐FEB‐1998BK040060‐0AcroMetrixCorporation6058EgretCourtBenicia,CA94510TradeName:VeriSureProExternalQualityControlsClearedDate:03‐MAY‐2005BK050061‐0AcroMetrixCorporation6058EgretCourtBenicia,CA94510TradeName:VeriSureProWNVRNANegativeExternalQualityControlVeriSureProWNVRNAPositiveExternalQualityControlVeriSureProWestNileVirus(WNV)RNAExternalQualityControls:ClearedDate:21‐DEC‐2005BK060064‐0AcroMetrixCorporation6058EgretCourtBenicia,CA94510TradeName:VeriSureProHBVDNAExternalQualityControlClearedDate:08‐FEB‐2007BK960002‐0ActivatedCellTherapyInc.
291NorthBernardoAvenueMountainView,CA94043TradeName:ACTBuoyantDensitySolutionClearedDate:12‐AUG‐1996BK190393‐0AeonBiotherapeuticsCorp.
12F.
,No.
58,RuihuSt.
TaipeiCity,NeihuDistTAIWAN11494TradeName:AeonCPKitAutologousCellPrepKitClearedDate:05‐JUN‐2020BK170013‐0AlbaBioscienceLimited21Ellen'sGlenRdEdinburgh,TradeName:AlbaQ‐Chek(R)SimulatedWholeBloodControls,ModelZ498ClearedDate:09‐MAY‐2017BK170086‐0AlbaBioscienceLimited21Ellen'sGlenRdEdinburgh,TradeName:AlbaQ‐ChekSimulatedWholeBloodControlsClearedDate:20‐OCT‐2017BK180286‐0AlbaBioscienceLimitedJamesHamiltonWayPenicuik,MidlothianUNITEDKINGDOMEH260BFTradeName:ALBAcytelgGSensitizedRedBloodCellsIIClearedDate:05‐FEB‐2019BK190389‐0AlbaBioscienceLimitedJamesHamiltonWayPenicuik,MidlothianUNITEDKINGDOMEH260BFTradeName:ALBAcheckBGSMonoclonalControlALBAcheckBGSMonoclonalControlClearedDate:26‐NOV‐2019BK160045‐0AlliancePartnersLLC14206NorthbrookDriveSanAntonio,TX78232TradeName:CyclonePlateletRichPlasma(PRP)ConcentratingSystemClearedDate:04‐NOV‐2016BK170108‐0AlliancePartnersLLC14206NorthbrookDriveSanAntonio,TX78232TradeName:CycloneBlood&BoneMarrowConcentration(BBMC)SystemClearedDate:02‐JAN‐2018BK190361‐0AllianceTechnologies,LLC1552WestGriswoldRdPhoenix,,AZ85021TradeName:BloodRelay1.
0.
0ClearedDate:17‐SEP‐2019BK940054‐0AlphaScientificCorporationP.
O.
Box725Southeastern,PA19399TradeName:SEG‐Safe(TM)ClearedDate:15‐MAR‐1995BK950014‐0AlphaScientificCorporationP.
O.
Box725Southeastern,PA19399TradeName:SEG‐SAFEClearedDate:31‐MAR‐1995BK860014‐0AlphaTherapeuticCorporation5555ValleyBoulevardLosAngeles,CA90032TradeName:JMSDoubleBloodCollectionPackClearedDate:04‐JUN‐1986BK870004‐0AlphaTherapeuticCorporation5555ValleyBoulevardLosAngeles,CA90032TradeName:PlasmaTransferPackClearedDate:11‐MAR‐1987BK950044‐0AlphaTherapeuticCorporation13111TempleAvenueCityofIndustry,CA91746TradeName:TransferDeviceClearedDate:18‐OCT‐1995BK950021‐0AltonDeanMedical,Inc.
1547West2290SouthWoodsCross,UT84087TradeName:AltonDeanModelFW‐437ClearedDate:15‐MAY‐1995BK960030‐0AmericanBloodResourcesAssociationPOBox669Annapolis,MD21404TradeName:NationalDonorDeferralRegistryClearedDate:20‐MAR‐1997BK010012‐0AmericanBloodResourcesAssociation147OldSolomonsIslandRd.
Annapolis,MD21401TradeName:NationalDonorDeferralRegistry(NDDR)‐1.
0ClearedDate:06‐SEP‐2001BK960040‐0AmericanRedCrossDiagnosticManufacturingDivision2025EStreetNWWashington,DC20006TradeName:NBCS1.
1ClearedDate:28‐FEB‐1997BK090021‐0AmericanRedCrossDiagnosticManufacturingDivision2025EStreetNWWashington,DC20006TradeName:ControlCellsClearedDate:24‐JUN‐2009BK120042‐0AmericanRedCrossDiagnosticManufacturingDivision2025EStreetNWWashington,DC20006TradeName:DailyChekQCKitClearedDate:06‐OCT‐2012BK820016‐0AmericanRedCrossBloodServices15601CrabbsBranchWayRockville,MD20855TradeName:ARCHLAExtendedTraysARCHLATraysClearedDate:01‐JUN‐1983BK840015‐0AmericanRedCrossBloodServices15601CrabbsBranchWayRockville,MD20855TradeName:BovineAlbumin3%ClearedDate:25‐OCT‐1984BK880021‐0AmericanRedCrossBloodServices15601CrabbsBranchWayRockville,MD20855TradeName:Frozen‐DriedBromeleinClearedDate:21‐DEC‐1988BK020032‐0AmericanRedCrossBloodServicesQualityandRegulatoryAffairs1616FortMyerDriveArlington,VA22209TradeName:NGTLAutomationSystem(NAS)‐5.
2.
0ClearedDate:20‐MAR‐2003BK850010‐0AmtecDiagnosticsInternationalInc.
1107IH‐45SouthConroe,TX77305TradeName:Rh‐HrControlBK850023‐0BK860002‐0BK860003‐0BK860008‐0BK860009‐0BK860010‐0BK860020‐0BK860021‐0ClearedDate:27‐DEC‐1985AmtecDiagnosticsInternationalInc.
1107IH‐45SouthConroe,TX77305TradeName:AmtecCM‐TecControlClearedDate:30‐DEC‐1985AmtecDiagnosticsInternationalInc.
1107IH‐45SouthConroe,TX77305TradeName:BovineAlbumin22%ClearedDate:03‐MAR‐1986AmtecDiagnosticsInternationalInc.
1107IH‐45SouthConroe,TX77305TradeName:BovineAlbumin30%ClearedDate:03‐MAR‐1986AmtecDiagnosticsInternationalInc.
1107IH‐45SouthConroe,TX77305TradeName:AmtecAnti‐A1LectinClearedDate:16‐JUN‐1986AmtecDiagnosticsInternationalInc.
1107IH‐45SouthConroe,TX77305TradeName:AmtecAnti‐NLectinClearedDate:18‐SEP‐1987AmtecDiagnosticsInternationalInc.
1107IH‐45SouthConroe,TX77305TradeName:AmtecPSClearedDate:16‐DEC‐1986AmtecDiagnosticsInternationalInc.
1107IH‐45SouthConroe,TX77305TradeName:AmtecR‐E‐SSystemClearedDate:25‐FEB‐1987AmtecDiagnosticsInternationalInc.
1107IH‐45SouthConroe,TX77305TradeName:AmtecCoombsControlCellsClearedDate:26‐AUG‐1986BK860026‐0AmtecDiagnosticsInternationalInc.
1107IH‐45SouthConroe,TX77305TradeName:AmtecAnti‐HLectinClearedDate:27‐JAN‐1987BK860036‐0AmtecDiagnosticsInternationalInc.
1107IH‐45SouthConroe,TX77305TradeName:ModelSeries,Mini&BBClearedDate:24‐FEB‐1987BK870020‐0AmtecDiagnosticsInternationalInc.
1107IH‐45SouthConroe,TX77305TradeName:AmtecFicinSystemClearedDate:02‐FEB‐1988BK010024‐0AppliedBiosystems850LincolnCentreDriveFosterCity,CA94404TradeName:ViroSeqHIV‐1GenotypingSystemClearedDate:10‐DEC‐2002BK030005‐0AppliedBiosystems1401HarborBayParkwayAlameda,CA94502TradeName:ViroSeqHIV‐1GenotypingSystemClearedDate:29‐JAN‐2003BK010031‐0AppliedScience,Inc.
964‐BGoldenGateTerraceGrassValley,CA95945TradeName:HemoflowModel400withDataScannerClearedDate:23‐JAN‐2002BK990011‐0AppliedSciences,Inc.
964‐BGoldenGateTerraceGrassValley,CA95945TradeName:HemoFlowDonorMonitorClearedDate:16‐JUL‐1999BK990019‐0AppliedSciences,Inc.
964‐BGoldenGateTerraceGrassValley,CA95945TradeName:HemoFlowDonorMonitorandMixerClearedDate:05‐OCT‐1999BK200512‐0Arc‐OneSolutions,LLC7901RivieraBlvdMiramar,FL33023TradeName:RegulatedSoftwareApplication(RSA)‐Version2.
0ClearedDate:15‐OCT‐2020BK020031‐0ArlingtonScientific,Inc.
1840NorthTechnologyDr.
Springville,UT84663TradeName:ASITPHATestClearedDate:30‐JAN‐2003BK130001‐0ArlingtonScientific,Inc.
1840NorthTechnologyDr.
Springville,UT84663TradeName:ASiManager‐ATClearedDate:24‐FEB‐2014BK140192‐0ArlingtonScientific,Inc.
1840NorthTechnologyDr.
Springville,UT84663TradeName:ASiManager‐ATClearedDate:19‐FEB‐2015BK170114‐0ArlingtonScientific,Inc.
1840NorthTechnologyDr.
Springville,UT84663TradeName:ASIEvolution‐2800‐000ClearedDate:28‐DEC‐2017BK200488‐0ArlingtonScientific,Inc.
1840NorthTechnologyDr.
Springville,UT84663TradeName:ASIAutomatedRPRtestforSyphilisforuseontheASIEvolutionASIEvolutionClearedDate:30‐SEP‐2020BK200539‐0ArlingtonScientific,Inc.
1840NorthTechnologyDr.
Springville,UT84663TradeName:ASIAutomatedRPRtestforSyphilisforuseontheASIEvolutionASIEvolutionClearedDate:02‐FEB‐2021BK940022‐0ArrowInternational,Inc.
P.
O.
Box128883000BernvilleRoadReading,PA19612TradeName:ArrowQwik‐1TMBloodandFluidAdministrationSetClearedDate:14‐JUL‐1994BK950036‐0ArrowInternational,Inc.
P.
O.
Box128883000BernvilleRoadReading,PA19612TradeName:ArrowHighFlowFluidAdm.
SetwithBloodFilter&ClearedDate:02‐AUG‐1995BK070069‐0Arthrex,Inc.
1370CreeksideBoulevardNaples,FL34108TradeName:ArthrexDoubleSyringe(ACP,AutologousConditionedPlasma)SystemClearedDate:12‐DEC‐2008BK170144‐0Arthrex,Inc.
1370CreeksideBoulevardNaples,FL34108TradeName:ArthrexThrombinatorSystemThrombinatorSystemforusewiththeArthrexAngelconcentratedPlateletRichPlasma(PRP)SystemClearedDate:10‐MAY‐2018BK180180‐0Arthrex,Inc.
1370CreeksideBoulevardNaples,FL34108TradeName:ArthrexAngelSystemKitsClearedDate:05‐JUL‐2018BK180299‐0Arthrex,Inc.
1370CreeksideBoulevardNaples,FL34108TradeName:ArthrexThrombinatorSystemClearedDate:07‐MAR‐2019BK190383‐0Arthrex,Inc.
1370CreeksideBoulevardNaples,FL34108TradeName:ArthrexAngelSystemClearedDate:18‐SEP‐2019BK190406‐0Arthrex,Inc.
1370CreeksideBoulevardNaples,FL34108TradeName:ArthrexDoubleSyringe(ACP)SystemClearedDate:06‐NOV‐2019BK200442‐0Arthrex,Inc.
1370CreeksideBoulevardNaples,FL34108TradeName:ArthrexDoubleSyringe(ACP)SystemClearedDate:09‐JUL‐2020BK910017‐0Assoc.
ofCapeCodP.
O.
Box224WoodsHole,MA02543TradeName:ControlStandardEndotoxin/PepyrogenerationValid.
ClearedDate:21‐OCT‐1991BK940032‐0AugustineMedical,Inc.
10393West70thStreetEdenPrairie,MN55344TradeName:BairHuggerPatientWarmingDeviceClearedDate:29‐SEP‐1994BK190433‐0AuraGenAestheticsLLC11DellbrookRdWeston,MA02493TradeName:AuraGen1‐2‐3withAuraClensSuctionLipoplastySystem(A123+AuraClens)ClearedDate:13‐MAR‐2020BK130049‐0B.
T.
IBiotechnologyInstitute,S.
L.
LeonardoDaVinci14ParqueTecnologicoDeAlavaMinano,AlavaSPAIN01510TradeName:BTIBiotechnologyInstituteS.
L.
EndoretKitforPlateletandPlasmaSeparatorClearedDate:16‐JAN‐2014BK150294‐0B.
T.
IBiotechnologyInstitute,S.
L.
LeonardoDaVinci14ParqueTecnologicoDeAlavaMinano,AlavaSPAIN01510TradeName:ENDORETKitClearedDate:09‐DEC‐2015BK930027‐0BBIDiagnostics,ASeraCareCompany375WestStreetWestBridgewater,MA02379TradeName:Accurun1ClearedDate:25‐OCT‐1994ClearedUnderBostonBiomedica,Inc.
BK970004‐0BBIDiagnostics,ASeraCareCompany375WestStreetWestBridgewater,MA02379TradeName:ACCURUN155ClearedDate:23‐APR‐1999ClearedUnderBostonBiomedica,Inc.
BK990032‐0BBIDiagnostics,ASeraCareCompany375WestStreetWestBridgewater,MA02379TradeName:Accurun106HIV‐1AntigenClearedDate:20‐JAN‐2000ClearedUnderBostonBiomedica,Inc.
BK010038‐0BBIDiagnostics,ASeraCareCompany375WestStreetWestBridgewater,MA02379TradeName:Accurun1MultimarkerNegativeControlClearedDate:18‐DEC‐2001ClearedUnderBostonBiomedica,Inc.
BK040006‐0BBIDiagnostics,ASeraCareCompany375WestStreetWestBridgewater,MA02379TradeName:ACCURUN315HIV‐1RNAPositiveControlClearedDate:12‐OCT‐2004ClearedUnderBostonBiomedica,Inc.
BK040016‐0BBIDiagnostics,ASeraCareCompany375WestStreetWestBridgewater,MA02379TradeName:ACCURUN305HCVRNAPositiveQualityControlClearedDate:17‐DEC‐2004ClearedUnderBostonBiomedica,Inc.
BK040064‐0BBIDiagnostics,ASeraCareCompany375WestStreetWestBridgewater,MA02379TradeName:ACCURUN345HIV‐1RNA,HCVRNA,HBVDNAPositiveQualityControlSeries150ClearedDate:29‐OCT‐2004ClearedUnderBostonBiomedica,Inc.
BK040067‐0BBIDiagnostics,ASeraCareCompany375WestStreetWestBridgewater,MA02379TradeName:ACCURUN803NucleicAcidNegativeQualityControl(HIV,HCV,HBV)ClearedDate:19‐NOV‐2004ClearedUnderBostonBiomedica,Inc.
BK060022‐0BBIDiagnostics,ASeraCareCompany375WestStreetWestBridgewater,MA02379TradeName:ACCURUN365WestNileVirusRNAPositiveQualityControlClearedDate:12‐JUN‐2006BK060030‐0BBIDiagnostics,ASeraCareCompany375WestStreetWestBridgewater,MA02379TradeName:ACCURUN804NucleicAcidNegativeQualityControl(HIV,HCV,HBV,WNV)ClearedDate:18‐AUG‐2006BK100037‐0BBKTechnologyLLC2910EHighlandAvePhoenix,AZ85016TradeName:RC‐AIDClearedDate:13‐SEP‐2010BK030027‐0BDBiosciences2350QumeDriveSanJose,CA95131‐1807TradeName:BDIMAGNMicrovolumeFluorimeterandBDIMAGNrWBCAssayKitClearedDate:10‐JUL‐2003BK050062‐0BDBiosciences2350QumeDriveSanJose,CA95131‐1807TradeName:BDHLA‐B27kitClearedDate:27‐OCT‐2005BK050073‐0BDBiosciences2350QumeDriveSanJose,CA95131‐1807TradeName:BDHLA‐B27SystemClearedDate:16‐FEB‐2006BK110037‐0BDBiosciences2350QumeDriveSanJose,CA95131‐1807TradeName:BDStemCellEnumerationKitClearedDate:19‐OCT‐2011BK150307‐0BDBiosciences2350QumeDriveSanJose,CA95131‐1807TradeName:BDFACSViaSystemwiththeBDLeucocountreagentAssayClearedDate:16‐SEP‐2016BK970024‐0BECTONDICKINSONVACUTAINERSystems1BectonDriveFranklinLakes,NJ07417TradeName:PlasmaPreparationTube‐PPTClearedDate:10‐AUG‐1998BK980011‐0BECTONDICKINSONVACUTAINERSystems1BectonDriveFranklinLakes,NJ07417TradeName:VACUTAINERBrandPLUS(Plastic)BloodCollectionTubewithEDTAAnticoagulantClearedDate:07‐JUN‐1999BK820008‐0BMTIncorporated7315HazeltineBoulevardExcelsior,MN55331TradeName:BMTModel24BloodmixerClearedDate:22‐OCT‐1982BK940031‐0BardRadiology10115Highway142Covington,GA30209TradeName:True‐PulseInfusionCatheterClearedDate:27‐APR‐1995BK100063‐0BarkeyGmbH&CoKGGewerbestrasse8D‐33818Leopoldshoehe,LeopoldshoeheGERMANY33818TradeName:plasmathermClearedDate:14‐SEP‐2017BK170028‐0BaxaltaUSInc.
OneBaxterWayWestlakeVillage,CA91362TradeName:myPKFiTforADVATEVersion2.
0ClearedDate:14‐DEC‐2017BK900010‐0BaxterHealthcareCorporation1851DelawareParkwayMiami,FL33152TradeName:DadeChemicallyModifiedControlReagentClearedDate:21‐SEP‐1990BK920025‐0BaxterHealthcareCorporation1BaxterPkwy.
Deerfield,IL60015TradeName:DadeFetal‐CyteScreeningKitClearedDate:05‐AUG‐1993BK940062‐0BaxterHealthcareCorporation1BaxterPkwy.
Deerfield,IL60015TradeName:CryocyteTMClearedDate:27‐DEC‐1994BK950049‐0BaxterHealthcareCorporation9ParkerIrvine,CA92618TradeName:CryocyteFreezingContainerClearedDate:14‐FEB‐1996BK960010‐0BaxterHealthcareCorporation9ParkerIrvine,CA92618TradeName:CellWashSetClearedDate:22‐MAY‐1996BK980001‐0BaxterHealthcareCorporation1BaxterPkwy.
Deerfield,IL60015TradeName:CultureProTissueCultureFlaskClearedDate:19‐FEB‐1998BK980012‐0BaxterHealthcareCorporation1BaxterPkwy.
Deerfield,IL60015TradeName:N/AClearedDate:18‐MAY‐1998BK020002‐0BaxterHealthcareCorporation550NorthBrandBlvd.
Glendale,CA91203TradeName:SerologySQLLIMS‐1.
0ClearedDate:07‐AUG‐2002BK020059‐0BaxterHealthcareCorporation25212WestILLRoute120RoundLake,IL60073TradeName:ALYXComponentCollectionSystemClearedDate:23‐JAN‐2003BK170033‐0BaxterHealthcareCorporation32650NorthWilsonRdRoundLake,IL60073TradeName:DUOSetDUOSetADUPLOCATHApplicationCatheterDUPLOJECTClearedDate:24‐JUL‐2017BK030052‐0BayerHealthCareDiagnosticsDivision700BAYStreet,Suite1000Toronto,OntarioM5G1Z6CANADATradeName:TRUGENEHIV‐1GenotypingKitandOpenGeneDNASequencingSystemClearedDate:08‐OCT‐2003BK040052‐0BayerHealthCareDiagnosticsDivision700BAYStreet,Suite1000Toronto,OntarioM5G1Z6CANADATradeName:TRUGENEHIV‐1GenotypingKitandOpenGeneDNASequencingSystemClearedDate:15‐OCT‐2004BK050035‐0BayerHealthCareDiagnosticsDivisionP.
O.
Box2466Berkeley,CA94702‐5828TradeName:TRUGENEHIV‐1GenotypingKitandOpenGeneDNASequencingSystemClearedDate:20‐SEP‐2005BK010044‐0BeckmanCoulter,Inc.
11800SW147Avenue(M/C:31‐B06)Miami,FL33196‐2500TradeName:stemONESystemforEPICSXL/XL‐MCLFlowCytometrySystemsClearedDate:20‐MAY‐2002BK020063‐0BeckmanCoulter,Inc.
11800SW147Avenue(M/C:31‐B06)Miami,FL33196‐2500TradeName:LeukoSureEnumerationKitwithLeuko‐TrolRBCControlCellsandLeukoTrolPlateletControlCellsClearedDate:03‐FEB‐2003BK040032‐0BeckmanCoulter,Inc.
11800SW147Avenue(M/C:31‐B06)Miami,FL33196‐2500TradeName:Stem‐KitReagentsClearedDate:05‐MAY‐2004BK040055‐0BeckmanCoulter,Inc.
11800SW147Avenue(M/C:31‐B06)Miami,FL33196‐2500TradeName:stemCXPSystemfortheFC500withCXPSoftwareClearedDate:16‐SEP‐2004BK180292‐0BeckmanCoulter,Inc.
250SouthKraemerBlvdBrea,CA92821TradeName:PK7400AutomatedMicroplateSystemClearedDate:07‐MAY‐2020BK930010‐0BectonDickinsonImmunocytometrySystems2350QumeDriveSanJose,CA95131TradeName:HLA‐B27ScreeningSystemsClearedDate:09‐SEP‐1993BK940015‐0BectonDickinsonImmunocytometrySystems2350QumeDriveSanJose,CA95131TradeName:TheHLA‐B27SystemClearedDate:24‐OCT‐1994BK960087‐0BectonDickinsonImmunocytometrySystems2350QumeDriveSanJose,CA95131TradeName:ProCountProgenitorCellEnumerationKitClearedDate:04‐JUN‐1998BK970038‐0BectonDickinsonImmunocytometrySystems2350QumeDriveSanJose,CA95131TradeName:ProcountSoftwareClearedDate:04‐FEB‐1999BK970046‐0BectonDickinsonImmunocytometrySystems2350QumeDriveSanJose,CA95131TradeName:LeucoCOUNTReagentClearedDate:14‐AUG‐1998BK950068‐0Becton,Dickinson&Company1BectonDrive,MC300FranklinLakes,NJ07417‐1885TradeName:CMVScanCardTestClearedDate:22‐DEC‐1995BK040030‐0Becton,Dickinson&Company1BectonDrive,MC300FranklinLakes,NJ07417‐1885TradeName:BDVacutainerPlusPlasticSerumTubeswithClotActivatorClearedDate:05‐MAY‐2004BK050036‐0Becton,Dickinson&Company1BectonDrive,MC300FranklinLakes,NJ07417‐1885TradeName:BDVacutainerPlusK2EDTATubesBDVacutainerPlusSerumTubesBDVacutainerSSTGlassTubesBDVacutainerSSTIIAdvanceTubesBDVacutainerSSTPlusTubesClearedDate:24‐FEB‐2006BK060046‐0Becton,Dickinson&Company1BectonDrive,MC300FranklinLakes,NJ07417‐1885TradeName:Bd.
idPatientIdentificationSystemforTransfusionManagement‐V7.
00ClearedDate:13‐FEB‐2007BK180211‐0Becton,Dickinson&Company7LovetonCircle,MC694Sparks,MD21152‐0999TradeName:BDBACTECPlateletAerobic/FCulturevialsBDBACTECPlateletAnaerobic/FCultureVialsClearedDate:08‐AUG‐2018BK200530‐0Becton,Dickinson&Company7LovetonCircle,MC694Sparks,MD21152‐0999TradeName:BDBACTECPlateletAerobic/FCultureVialsBDBACTECPlateletAnaerobic/FCultureVialsClearedDate:23‐DEC‐2020BK960001‐0BehringDiagnostics175UniversityAvenueWestwood,MA02090TradeName:OPUSCMVClearedDate:09‐OCT‐1996BK850022‐0BellhouseMedicalProductsLtd.
LarkhillHouse;AbingdonOxford,OX141AS,TradeName:PlateletScreeningTestClearedDate:12‐NOV‐1985BK150301‐0BelmontInstrumentCorporation780BostonRoadBillerica,MA01821TradeName:TheBelmontbuddy(TM)2Blood/FluidWarmerClearedDate:02‐SEP‐2015BK140112‐0Bio‐RadLaboratories6565185thAveNEClinicalDiagnosticsGroupRedmond,WA98052‐5039TradeName:BioPlex2200SystemClearedDate:23‐JUL‐2015BK130070‐0Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:MLB210x10mLClearedDate:27‐NOV‐2013BK140106‐0Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:IH‐1000ClearedDate:20‐OCT‐2016BK140107‐0Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:IH‐COMClearedDate:20‐OCT‐2016BK140138‐0Bio‐RadMedicalDiagnosticsGmbHBK140139‐0BK150327‐0BK170019‐0BK170021‐0BK170064‐0BK170065‐0BK170066‐0BK170071‐0Industriestrasse1Dreieich,GERMANY63303TradeName:IH‐CardNeutralClearedDate:20‐OCT‐2016Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:IH‐CardControlClearedDate:20‐OCT‐2016Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:TangoInfinityTMClearedDate:16‐DEC‐2015Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:IH‐1000(Model#001100)ClearedDate:05‐MAY‐2017Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:IH‐ComV5.
0ClearedDate:05‐MAY‐2017Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:IH‐InternalQCClearedDate:18‐DEC‐2017Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:IH‐CenttrifugeLClearedDate:18‐DEC‐2017Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:IH‐IncubatorLClearedDate:18‐DEC‐2017Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303BK170075‐0BK180174‐0BK180175‐0BK180225‐0BK180226‐0BK180274‐0BK180275‐0BK190312‐0TradeName:IH‐ComV5.
0ClearedDate:26‐SEP‐2017Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:IH‐BasicQCIH‐QCSystemClearedDate:20‐DEC‐2017Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:IH‐ComV5.
0ClearedDate:01‐MAY‐2018Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:TANGOInfinityClearedDate:01‐MAY‐2018Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:IH‐Reader24ClearedDate:28‐SEP‐2018Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:IH‐ComV5.
0ClearedDate:28‐SEP‐2018Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:IH‐500AnalyzerClearedDate:21‐MAR‐2019Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:IH‐Com‐5.
0ClearedDate:21‐MAR‐2019Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:TANGOinfinityClearedDate:25‐APR‐2019BK190388‐0Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:TANGOInfinityClearedDate:13‐DEC‐2019BK190424‐0Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:IH‐COMV5.
2‐12010236ClearedDate:20‐DEC‐2019BK200548‐0Bio‐RadMedicalDiagnosticsGmbHIndustriestrasse1Dreieich,GERMANY63303TradeName:IH‐1000ClearedDate:12‐JAN‐2021BK970035‐0BioAccess,Inc.
8400CedarStreetSilverSpring,MD20910TradeName:BioaccessMarrowCollectionSystemClearedDate:23‐DEC‐1998BK130050‐0BioArraySolutions,Ltd.
35TechnologyDriveSuite100Warren,NJ07059TradeName:BeadCheckHEAPositiveControlClearedDate:21‐MAY‐2014BK130051‐0BioArraySolutions,Ltd.
35TechnologyDriveSuite100Warren,NJ07059TradeName:BioArrayImagingSystem(AIS)400CClearedDate:21‐MAY‐2014BK150270‐0BioArraySolutions,Ltd.
35TechnologyDriveSuite100Warren,NJ07059TradeName:ArrayImagingSystemAS400DClearedDate:15‐JUN‐2015BK000046‐0BioE,Inc.
4280CentervilleRoadSt.
Paul,MN55127TradeName:FluoroTrolControlKitsClearedDate:02‐APR‐2001ClearedUnderBioErgonomics,Inc.
BK070067‐0BioE,Inc.
4280CentervilleRoadSt.
Paul,MN55127TradeName:PrepaCyte(R)‐CBProcessingSystemClearedDate:17‐DEC‐2008BK150347‐0BioLifePlasmaServicesL.
P.
‐BaxaltaUSInc440N.
FairwayDrive,2W‐141VernonHills,IL60061TradeName:LookbackNotificationSystem(LNS),Version1.
0ClearedDate:12‐FEB‐2016BK160103‐0BioLifePlasmaServicesL.
P.
‐BaxaltaUSInc440N.
FairwayDrive,2W‐141VernonHills,IL60061TradeName:AutomatedPlasmaDispositioningSystem(APDS)‐Version2.
0ClearedDate:15‐NOV‐2016BK050029‐0BioLifePlasmaServicesLPOneBaxterParkwayDeerfield,IL60015TradeName:DonorInformationSystem(DIS)‐3.
1ClearedDate:07‐JUL‐2005BK060017‐0BioLifePlasmaServicesLPOneBaxterParkwayDeerfield,IL60015TradeName:DonorInformationSystem(DIS)‐3.
2ClearedDate:09‐MAY‐2006BK080016‐0BioLifePlasmaServicesLPOneBaxterParkwayDeerfield,IL60015TradeName:DonorInformationSystem‐v3.
3ClearedDate:02‐JUL‐2008BK090001‐0BioLifePlasmaServicesLPOneBaxterParkwayDeerfield,IL60015TradeName:DonorInformationSystem(DIS)‐version4.
0ClearedDate:18‐AUG‐2009BK100021‐0BioLifePlasmaServicesLPOneBaxterParkwayDeerfield,IL60015TradeName:DonorInformationSystem(DIS)ClearedDate:18‐JUN‐2010BK120064‐0BioLifePlasmaServicesLPOneBaxterParkwayDeerfield,IL60015TradeName:DonorInformationSystem(DIS)v6.
0ClearedDate:19‐DEC‐2012BK120069‐0BioLifePlasmaServicesLPOneBaxterParkwayDeerfield,IL60015TradeName:AutomatedPlasmaDIspositioningSystem(APDS)v1.
0ClearedDate:31‐MAY‐2013BK140164‐0BioLifePlasmaServicesLPOneBaxterParkwayDeerfield,IL60015TradeName:DonorInformationSystem(DIS)‐7.
0ClearedDate:20‐OCT‐2014BK970017‐0BioMerieux1022HinghamStreetRockland,MA02370TradeName:HLA‐DROligoDetectionKitClearedDate:28‐MAY‐1998BK130028‐0BiofortunaLTD1HawksheadRoadCroftBusinessParkWirral,MerseysideUNITEDKINGDOMCH623RJTradeName:BiofortunaLtd.
SSPGoHLATypingKitClearedDate:19‐DEC‐2013ClearedUnderBiofortunaLTDBK090082‐0BiomatUSA,Inc.
1311TempleAvenueCityofIndustry,CA91746TradeName:SGPVersion7.
0(PlasmaManagementSystem)ClearedDate:01‐OCT‐2010BK180240‐0BiomatUSA,Inc.
2410LillyvaleAveLosAngeles,CA90032TradeName:GDS(GrifolsDonationSystem)‐1.
0ClearedDate:05‐NOV‐2018BK200517‐0BiomatUSA,Inc.
2410LillyvaleAveLosAngeles,CA90032TradeName:GDS(GrifolsDonationSystem)ClearedDate:05‐NOV‐2020BK020019‐0BiometBiologics,Inc.
56EastBellDrivePOBox587Warsaw,IN46581‐0587TradeName:PCCSGraftDeliverySystemClearedDate:19‐JUN‐2002BK040036‐0BiometBiologics,Inc.
56EastBellDrivePOBox587Warsaw,IN46581‐0587TradeName:GPSIIPlateletConcentrateSeparationKitClearedDate:18‐JUN‐2004ClearedUnderBiomet,Inc.
BK050016‐0BiometBiologics,Inc.
56EastBellDrivePOBox587Warsaw,IN46581‐0587TradeName:FibrostikPlasmaConcentratorClearedDate:20‐JUL‐2005ClearedUnderBiomet,Inc.
BK070003‐0BiometBiologics,Inc.
56EastBellDrivePOBox587Warsaw,IN46581‐0587TradeName:GPSIIPlateletConcentrationSeparationKitwithACD‐APlasmaxPlasmaConcentratorwithGPSMiniPlateletConcentrateSeparationKitwithACD‐AClearedDate:22‐FEB‐2007ClearedUnderBiomet,Inc.
BK070026‐0BiometBiologics,Inc.
56EastBellDrivePOBox587Warsaw,IN46581‐0587TradeName:GPSIIIMiniPlateletConcentrateSeparationKitwithACD‐AGPSIIIPlateletConcentrateSeparationKitwithACD‐AGPSIIIPlateletConcentrateSeparationKitwithACD‐ADoubleKitClearedDate:06‐JUN‐2007ClearedUnderBiomet,Inc.
BK070036‐0BiometBiologics,Inc.
56EastBellDrivePOBox587Warsaw,IN46581‐0587TradeName:VortechConcentrationSystemClearedDate:21‐NOV‐2007BK080004‐0BiometBiologics,Inc.
56EastBellDrivePOBox587Warsaw,IN46581‐0587TradeName:ClotalystandGPSIIIMiniPlateletConcentrateSeparationKitwithACD‐AClotalystandGPSIIIPlateletConcentrateSeparationKitwithACD‐AClearedDate:14‐SEP‐2017BK090008‐0BiometBiologics,Inc.
56EastBellDrivePOBox587Warsaw,IN46581‐0587TradeName:MarrowStimConcentrationSystemClearedDate:18‐DEC‐2009BK090023‐0BiometBiologics,Inc.
56EastBellDrivePOBox587Warsaw,IN46581‐0587TradeName:CoAxialApplicatorSystemClearedDate:07‐AUG‐2009BK100027‐0BiometBiologics,Inc.
56EastBellDrivePOBox587Warsaw,IN46581‐0587TradeName:BioCUEPlateletConcentrationKitClearedDate:26‐MAY‐2010BK110040‐0BiometBiologics,Inc.
56EastBellDrivePOBox587Warsaw,IN46581‐0587TradeName:ClotalystKitwithGPS(R)IIISeparatorClearedDate:23‐DEC‐2011BK970015‐0BiometricImaging,Inc.
1025TerraBellaAvenueMountainView,CA94043TradeName:CEQerRBCAssayClearedDate:18‐SEP‐1998BK970016‐0BiometricImaging,Inc.
1025TerraBellaAvenueMountainView,CA94043TradeName:CEQerPRPAssayClearedDate:18‐SEP‐1998BK970018‐0BiometricImaging,Inc.
1025TerraBellaAvenueMountainView,CA94043TradeName:STELLerCD34AssayClearedDate:18‐AUG‐1998BK980035‐0BiopoolInternational,Inc.
1230WilsonDriveWestChester,PA19380‐4254TradeName:SliDeChekClearedDate:11‐JUN‐1999BK090037‐0BiosafeSARouteduPetit‐EysinsEysins,VaudSWITZERLAND1262TradeName:CryoSCFreezingBagClearedDate:22‐MAR‐2010BK110022‐0BiosafeSARouteduPetit‐EysinsEysins,VaudSWITZERLAND1262TradeName:SepaxCellSeparationandsingleusekitsClearedDate:28‐OCT‐2011BK140203‐0BiosafeSARouteduPetit‐EysinsEysins,VaudSWITZERLAND1262TradeName:SepaxCellSepartatonSystemandSIngleUseKitsClearedDate:13‐FEB‐2015BK840028‐0BiotechResearchLaboratories,Inc.
1600EastGudeDriveRockville,MD20850TradeName:RunControlforHBsAgAssayClearedDate:25‐JAN‐1985BK090069‐0BiotechnologyInstitute,SL.
C/LeonardoDaVinci14B,1B.
01510Minano(Alava)Alava,SPAIN01510TradeName:EndoretKitSecondaryProductCode:FMI,GKTClearedDate:01‐FEB‐2010BK060066‐0BiotestAGPostfach102040D‐63266Dreiech,GERMANYTradeName:TANGOAutomatedBloodBankAnalyzerSystem,Version3.
0ServicePack4ClearedDate:17‐JAN‐2007BK950015‐0BiotestDiagnosticsCorporation66FordRoad,Suite131Denville,NJ07834TradeName:BiotestDRB‐SSOTypingKitClearedDate:09‐JUN‐1995BK960061‐0BiotestDiagnosticsCorporation66FordRoad,Suite131Denville,NJ07834TradeName:BiotestDQB‐ELPHAClearedDate:04‐AUG‐1997BK960086‐0BiotestDiagnosticsCorporation66FordRoad,Suite131Denville,NJ07834TradeName:BiotestHighResolutionSupplementaryKitClearedDate:03‐JUL‐1997BK980007‐0BiotestDiagnosticsCorporation66FordRoad,Suite131Denville,NJ07834TradeName:BIOTESTDRB‐ELPHALowResolution(EnzymeLinkedProbeHybridizationAssay)ClearedDate:26‐JAN‐1999BK980033‐0BiotestDiagnosticsCorporation66FordRoad,Suite131Denville,NJ07834TradeName:LYMPHOSCREENABC60ClearedDate:15‐DEC‐1999BK980044‐0BiotestDiagnosticsCorporation66FordRoad,Suite131Denville,NJ07834TradeName:LymphoscreenDR30x2ClearedDate:15‐DEC‐1999BK020004‐0BiotestDiagnosticsCorporation66FordRoad,Suite131Denville,NJ07834TradeName:BiotestHLASSPKitClearedDate:07‐AUG‐2002BK080012‐0BiotestMedicalDiagnosticsGmbHP.
O.
Box10215063267Dreiech,GERMANYTradeName:(1)SeracloneControlABO+Rh(2)Coombscell‐E(3)MLB2ClearedDate:23‐JUL‐2008BK080013‐0BiotestMedicalDiagnosticsGmbHP.
O.
Box10215063267Dreiech,GERMANYTradeName:AlseversSolution(510(k)exemptbutpartofsystem)SolidscreenIIControlBSolidscreenNegativeControlTangoOptimoAutomatedBloodBankAnalyzerSystemwithversion3.
1ClearedDate:23‐JUL‐2008BK820009‐0Biotest‐Serum‐InstitutGmbHFlughafenstrasse46000Frankfurt/Main73,GERMANYTradeName:Anti‐HLALeukocyteTypingSerumClearedDate:20‐JAN‐1983BK820011‐0Biotest‐Serum‐InstitutGmbHFlughafenstrasse46000Frankfurt/Main73,GERMANYTradeName:MicrodropletTestingTray(LymphotypeABC‐72Well)ClearedDate:20‐JAN‐1983BK830027‐0Biotest‐Serum‐InstitutGmbHFlughafenstrasse46000Frankfurt/Main73,GERMANYTradeName:MicrotestTestingTray(HLA‐DRWells)ClearedDate:26‐APR‐1984BK170150‐0BiowyCorporation27031VistaTerraceLakeForest,CA92630TradeName:BiowyFreezingBagFB1000BiowyFreezingBagFB250BiowyFreezingBagFB50BiowyFreezingBagFB500ClearedDate:11‐MAY‐2018BK890015‐0BlackhawkBioSystems,Inc.
12945AlcostaBlvd.
SanRamon,CA94583TradeName:BloodScreening/DiagnosticSerumControlsClearedDate:17‐APR‐1992BK890019‐0BlackhawkBioSystems,Inc.
12945AlcostaBlvd.
SanRamon,CA94583TradeName:BloodBankSalineClearedDate:18‐JUL‐1990BK920008‐0BlackhawkBioSystems,Inc.
12945AlcostaBlvd.
SanRamon,CA94583TradeName:VIROTROLClearedDate:17‐SEP‐1992BK920028‐0BlackhawkBioSystems,Inc.
12945AlcostaBlvd.
SanRamon,CA94583TradeName:VirotrolHIV‐2ClearedDate:03‐JUN‐1993BK930016‐0BlackhawkBioSystems,Inc.
12945AlcostaBlvd.
SanRamon,CA94583TradeName:VirotrolIReagents(CMV)ClearedDate:16‐NOV‐1993BK930033‐0BlackhawkBioSystems,Inc.
12945AlcostaBlvd.
SanRamon,CA94583TradeName:VirotrolHIV‐AgClearedDate:27‐SEP‐1995BK930034‐0BlackhawkBioSystems,Inc.
12945AlcostaBlvd.
SanRamon,CA94583TradeName:VirotrolIIIClearedDate:27‐JUL‐1994BK950011‐0BlackhawkBioSystems,Inc.
12945AlcostaBlvd.
SanRamon,CA94583TradeName:ViroclearClearedDate:28‐AUG‐1995BK960085‐0BlackhawkBioSystems,Inc.
12945AlcostaBlvd.
SanRamon,CA94583TradeName:VIROTROLIIClearedDate:03‐OCT‐1997BK000041‐0BlackhawkBioSystems,Inc.
12945AlcostaBlvd.
SanRamon,CA94583TradeName:ViroclearClearedDate:28‐DEC‐2000BK060052‐0BlackhawkBioSystems,Inc.
12945AlcostaBlvd.
SanRamon,CA94583TradeName:AmpliTrolIIIClearedDate:07‐NOV‐2006BK960044‐0BloodBankComputerSystems,Inc.
1501WestValleyHighway,NorthSuite101Auburn,WA98001TradeName:BloodBankControlSystemClearedDate:15‐OCT‐1997BK040056‐0BloodBankComputerSystems,Inc.
100215thSt.
SW,Suite120Auburn,WA98001‐6502TradeName:BloodBankControlSystem(BBCS)‐5.
0ClearedDate:22‐OCT‐2004BK040087‐0BloodBankComputerSystems,Inc.
100215thSt.
SW,Suite120Auburn,WA98001‐6502TradeName:BBCSLabInterfaceApplication(BBCSLab)‐5.
0LClearedDate:15‐FEB‐2005BK050013‐0BloodBankComputerSystems,Inc.
100215thSt.
SW,Suite120Auburn,WA98001‐6502TradeName:BBCSMobileApplication‐5.
0MClearedDate:01‐JUN‐2005BK090081‐0BloodBankComputerSystems,Inc.
100215thSt.
SW,Suite120Auburn,WA98001‐6502TradeName:BBCSHospitalInterfaceApplication(BBCSH),H1.
0.
0ClearedDate:20‐JAN‐2010BK120028‐0BloodBankComputerSystems,Inc.
100215thSt.
SW,Suite120Auburn,WA98001‐6502TradeName:BBCSBloodTrackInterfaceApplication(BBCSBT),BT1.
0.
0BloodBankControlSystem‐V.
5.
0ClearedDate:21‐JUN‐2012BK140130‐0BloodBankComputerSystems,Inc.
100215thSt.
SW,Suite120Auburn,WA98001‐6502TradeName:ABOQuickPass,version1.
0.
0ClearedDate:10‐OCT‐2014BK140142‐0BloodBankComputerSystems,Inc.
100215thSt.
SW,Suite120Auburn,WA98001‐6502TradeName:BBCSPrimaryApplication,version5.
4.
3ClearedDate:10‐OCT‐2014BK140184‐0BloodBankComputerSystems,Inc.
100215thSt.
SW,Suite120Auburn,WA98001‐6502TradeName:ABOWheels‐1.
0.
0ClearedDate:30‐DEC‐2014BK140198‐0BloodBankComputerSystems,Inc.
100215thSt.
SW,Suite120Auburn,WA98001‐6502TradeName:ABOQuickPass‐1.
0.
0ClearedDate:04‐FEB‐2015BK160011‐0BloodBankComputerSystems,Inc.
100215thSt.
SW,Suite120Auburn,WA98001‐6502TradeName:ABOExpress‐Model2.
0.
0ClearedDate:26‐APR‐2016BK940048‐0BloodCare9000HarryHinesBlvd.
Dallas,TX75235TradeName:LifeTrak/Lab(a.
k.
a.
Lab*Care)‐V.
2.
01ClearedDate:01‐OCT‐1998BK100051‐0BoekelScientific,Inc855PennsylvaniaBlvd.
Feasterville,PA19053TradeName:BoekelPlasmaThawer,Model301000ClearedDate:22‐APR‐2011BK940025‐0BostonScientific,Inc.
1BostonScientificPlaceNatick,MA01760‐1537TradeName:KatzenThrombolysisGuidewareClearedDate:24‐JAN‐1996BK890009‐0C‐sixDiagnostics,Inc.
9653N.
GranvilleRd.
Meguon,WI53092TradeName:FrozenCellPanelTray(Human)ClearedDate:02‐AUG‐1989BK890010‐0C‐sixDiagnostics,Inc.
9653N.
GranvilleRd.
Meguon,WI53092TradeName:LeukocyteTypingSerumTrays(Human)ClearedDate:02‐AUG‐1989BK890011‐0C‐sixDiagnostics,Inc.
9653N.
GranvilleRd.
Meguon,WI53092TradeName:LeukocyteTypingSerumTrays(Human)ClearedDate:02‐AUG‐1989BK960049‐0CIS‐US,Inc.
10deAngeloDriveBedford,MA01730TradeName:DoseWriterClearedDate:25‐MAR‐1998BK950024‐0COBECardiovascular,Inc.
1201OakStreetLakewood,CO80215TradeName:COBEPlateletFiltrationandStorageSetClearedDate:29‐NOV‐1995ClearedUnderCOBEBCTBK950056‐0COBECardiovascular,Inc.
1201OakStreetLakewood,CO80215TradeName:CobeSpectraLRDLeukoreduction(SystemVersions)ClearedDate:31‐JAN‐1996ClearedUnderCOBEBCTBK950065‐0COBECardiovascular,Inc.
1201OakStreetLakewood,CO80215TradeName:CobeSpectrumApheresisSystem(stemcellcollection)ClearedDate:12‐NOV‐2002ClearedUnderCOBEBCTBK960076‐0COBECardiovascular,Inc.
1201OakStreetLakewood,CO80215TradeName:COBESpectraLRSTurboSystemClearedDate:14‐JUL‐1997ClearedUnderCOBEBCTBK970005‐0COBECardiovascular,Inc.
1201OakStreetLakewood,CO80215TradeName:FocussedSystemClearedDate:13‐OCT‐1998ClearedUnderCOBEBCTBK970023‐0COBECardiovascular,Inc.
1201OakStreetLakewood,CO80215TradeName:CollectionofpRBCUsingtheFocussedSystemClearedDate:13‐OCT‐1998ClearedUnderCOBEBCTBK980004‐0COBECardiovascular,Inc.
1201OakStreetLakewood,CO80215TradeName:COBESpectraApheresisSystemAnticoagulantFreeFlowRestrictionClearedDate:09‐JUL‐1998ClearedUnderCOBEBCTBK990025‐0COBECardiovascular,Inc.
1201OakStreetLakewood,CO80215TradeName:CobeTrimaClearedDate:07‐APR‐2000ClearedUnderCOBEBCTBK990040‐0COBECardiovascular,Inc.
1201OakStreetLakewood,CO80215TradeName:COBETrimawithther/LSRBCLeukoreductionFilterClearedDate:03‐MAR‐2000ClearedUnderCOBEBCTBK050033‐0COBECardiovascular,Inc.
14401West65thWayArvada,CO80004‐3599TradeName:COBEAngelWholeBloodSeparationSystemClearedDate:22‐AUG‐2005ClearedUnderCOBEBCTBK060010‐0COBECardiovascular,Inc.
14401West65thWayArvada,CO80004‐3599TradeName:COBEAngelWholeBloodSeparationSystemClearedDate:27‐FEB‐2006BK130003‐0CPSI6600WallStreetMobile,AL36695TradeName:BloodAdministration‐Version1800ClearedDate:30‐APR‐2014BK020020‐0CSLBehringAGWankdorfstrasse103014Bern,SWITZERLANDTradeName:SystemforPlasmaIdentification(SPI)‐1.
0ClearedDate:30‐OCT‐2002ClearedUnderZLBBehringAGBK050078‐0CSLBehringAGWankdorfstrasse103014Bern,SWITZERLANDTradeName:SystemforPlasmaIdentification(SPI)‐2.
0.
0ClearedDate:22‐DEC‐2005BK110023‐0CSLBehringAGWankdorfstrasse103014Bern,SWITZERLANDTradeName:SystemforPlasmaIdentification(SPI),version‐3.
1.
0ClearedDate:08‐JUN‐2011BK120002‐0CSLPlasma900BrokenSoundParkwaySuite400BocaRaton,FL33487TradeName:LOGICversion3.
0.
0ClearedDate:24‐APR‐2012ClearedUnderHaemoneticsCorporationBK190430‐0CSLPlasma900BrokenSoundParkwaySuite400BocaRaton,FL33487TradeName:Anti‐DDonorManagementandInventorySystem(ADIMS)‐Version1.
7ClearedDate:11‐MAR‐2020BK090054‐0CalimexUSACorporation258HollisterAvenuAlameda,CA94501TradeName:Picture‐IDClearedDate:11‐JAN‐2010BK110070‐0CalimexUSACorporation258HollisterAvenuAlameda,CA94501TradeName:eOrders,Version1‐1ClearedDate:17‐FEB‐2012BK120035‐0CalimexUSACorporation258HollisterAvenuAlameda,CA94501TradeName:Picture‐IDVersion2.
0ClearedDate:17‐DEC‐2012BK940027‐0CardiovascularDynamics,Inc.
15HammondSuite307Irvine,CA92718TradeName:CVDBullettInfusionCatheterClearedDate:27‐FEB‐1995BK940028‐0CardiovascularDynamics,Inc.
15HammondSuite307Irvine,CA92718TradeName:CVDBullettHi‐FloInfusionClearedDate:27‐FEB‐1995BK040002‐0CareFusion,Inc.
1430SpringHillRoad,Suite510McLean,VA22102TradeName:wBloodCare‐1.
0ClearedDate:10‐NOV‐2004BK080035‐0CaridianBCT10811W.
CollinsAvenueLakewood,CO80215‐4498TradeName:COBESpectraApheresisSystemTrimaAccelAutomatedBloodComponentCollectionSystemClearedDate:29‐AUG‐2008BK080043‐0CaridianBCT10811W.
CollinsAvenueLakewood,CO80215‐4498TradeName:AtreusWholeBloodProcessingSystemClearedDate:29‐SEP‐2008BK080058‐0CaridianBCT10811W.
CollinsAvenueLakewood,CO80215‐4498TradeName:TrimaAccelAutomatedBloodComponentCollectionSystemClearedDate:25‐NOV‐2008BK090003‐0CaridianBCT10811W.
CollinsAvenueLakewood,CO80215‐4498TradeName:TrimaAccelSystemClearedDate:16‐FEB‐2010BK100032‐0CaridianBCT10811W.
CollinsAvenueLakewood,CO80215‐4498TradeName:TrimaAccelSystemVersion6.
0ClearedDate:06‐AUG‐2010BK110009‐0CaridianBCT10811W.
CollinsAvenueLakewood,CO80215‐4498TradeName:TrimaAccelAutomatedBloodComponentCollectionSystemClearedDate:19‐APR‐2011BK110051‐0CaridianBCT10811W.
CollinsAvenueLakewood,CO80215‐4498TradeName:TrimaAccelAutomatedBloodComponentCollectionSystemversion5.
1.
8ClearedDate:20‐DEC‐2011BK110068‐0CaridianBCT10811W.
CollinsAvenueLakewood,CO80215‐4498TradeName:TrimaAccelAutomatedBloodCOmponentCollectionSystemClearedDate:23‐MAR‐2012BK990015‐0CarterBloodCare2205Highway121Bedford,TX76021TradeName:LifeTrak/Distribution‐2.
03ClearedDate:22‐OCT‐1999BK990027‐0CarterBloodCare2205Highway121Bedford,TX76021TradeName:LifeTrak/Donor‐2.
03ClearedDate:15‐DEC‐1999BK180246‐0CarterBloodCare2205Highway121Bedford,TX76021TradeName:BloodBankInformationSystem‐v2.
06.
00ClearedDate:01‐NOV‐2018BK200491‐0CarterBloodCare2205Highway121Bedford,TX76021TradeName:iWeBBelectronicLaboratoryInformationSystem(iWeBB‐eLIS)ClearedDate:29‐JUL‐2020BK200514‐0Cartiva,Inc.
6120WindwardPkwyAlpharetta,GA30005TradeName:CartivaSCIDisposableInstrumentationsetClearedDate:14‐AUG‐2020BK020051‐0CascadeMedicalEnterprises,LLC20GreenupCourtWayne,NJ07470TradeName:CascadeMedicalFibrinet,AutologousPlateletSystemClearedDate:20‐DEC‐2002BK030024‐0CascadeMedicalEnterprises,LLC20GreenupCourtWayne,NJ07470TradeName:CascadeMedicalFibrinetSystemClearedDate:02‐JUN‐2003BK060006‐0CascadeMedicalEnterprises,LLC20GreenupCourtWayne,NJ07470TradeName:CascadeMedicalFIBRINETSystemClearedDate:16‐FEB‐2006BK120009‐0CascadeMedicalEnterprises,LLC20GreenupCourtWayne,NJ07470TradeName:FIBRINET(R)AutologousPRPSystemClearedDate:01‐AUG‐2012BK170096‐0CascadeMedicalEnterprises,LLC20GreenupCourtWayne,NJ07470TradeName:FibrinetPlateletSystemFibrinetPlateletSystemClearedDate:21‐NOV‐2017BK030033‐0CeleraCorporation1401HarborBayParkwayAlameda,CA94502TradeName:ViroSeqHIV‐1GenotypingSystemClearedDate:11‐JUN‐2003ClearedUnderCeleraDiagnostics,LLCBK030088‐0CeleraCorporation1401HarborBayParkwayAlameda,CA94502TradeName:ViroSeqHIV‐1GenotypingSystemv2.
0ClearedDate:22‐JAN‐2004ClearedUnderCeleraDiagnostics,LLCBK060049‐0CeleraCorporation1401HarborBayParkwayAlameda,CA94502TradeName:ViroSeqHIV‐1GenotypingSystemClearedDate:31‐AUG‐2006ClearedUnderCeleraDiagnostics,LLCBK080026‐0CeleraCorporation1401HarborBayParkwayAlameda,CA94502TradeName:ViroSeqHIV‐1GenotypingSystemv2.
0ClearedDate:10‐JUL‐2008ClearedUnderCeleraDiagnostics,LLCBK130039‐0CeleraCorporation1401HarborBayParkwayAlameda,CA94502TradeName:ViroSeqHIV‐1GenotypingSystemv2.
0ClearedDate:05‐SEP‐2013BK150221‐0CellingBiosciences,Inc.
93RedRiverSt.
Austin,TX78701TradeName:CircleBiologicsAutologousPlateletSeparator(APS)SystemClearedDate:09‐JUN‐2015BK130079‐0CellmedixHoldings,LLC.
19ParkDriveFranklin,NJ07416TradeName:CentrepidPlateletConcentratorClearedDate:31‐JUL‐2014BK880002‐0CellularProducts688MainStreetBuffalo,NY14202TradeName:BloodBankRefrigeratorClearedDate:04‐MAY‐1988BK950010‐0Centocor,Inc.
200GreatValleyParkwayMalvern,PA19355TradeName:CAPTIACMV‐TAEIAClearedDate:22‐MAR‐1995BK950051‐0CernerCorporation2800RockCreekParkwayKansasCity,MO64117‐2551TradeName:PathnetBloodCenter(L‐2510)ClearedDate:16‐JUL‐1997BK950053‐0CernerCorporation2800RockCreekParkwayKansasCity,MO64117‐2551TradeName:PathnetBloodBankTransfusion(L‐2300)ClearedDate:16‐JUL‐1997BK950055‐0CernerCorporation2800RockCreekParkwayKansasCity,MO64117‐2551TradeName:PathnetBloodBankDonor(L2400)ClearedDate:16‐JUL‐1997BK960024‐0CernerCorporation2800RockCreekParkwayKansasCity,MO64117‐2551TradeName:PathNetWorksystemBloodBankTransfusion(L2812)ClearedDate:16‐JUL‐1997BK990007‐0CernerCorporation2800RockCreekParkwayKansasCity,MO64117‐2551TradeName:HNAMillenniumPathNetBloodBankTransfusionClearedDate:02‐NOV‐1999BK030028‐0CernerCorporation2800RockCreekParkwayKansasCity,MO64117‐2551TradeName:CernerMillenniumPathNetBloodBankDonor(PA‐22200)‐2003.
01ClearedDate:19‐AUG‐2003BK060037‐0CernerCorporation2800RockCreekParkwayKansasCity,MO64117‐2551TradeName:CernerBridgeMedicalTransfusionAdministrationandSpecimenCollections‐3.
3ClearedDate:24‐MAY‐2007BK860025‐0CetusCorporation140053rdStreetEmeryville,CA94608TradeName:ProGroupSystemClearedDate:27‐APR‐1987BK050021‐0CharterMedical,Ltd.
3948‐AWestpointBlvd.
Winston‐Salem,NC27103TradeName:CharterMedicalTransferSetClearedDate:22‐JUL‐2005BK060042‐0CharterMedical,Ltd.
3948‐AWestpointBlvd.
Winston‐Salem,NC27103TradeName:CellFreezeLiquidNitrogenFreezingContainerClearedDate:03‐OCT‐2008BK100049‐0CharterMedical,Ltd.
3948‐AWestpointBlvd.
Winston‐Salem,NC27103TradeName:Cell‐FreezeCryogenicStorageContainerClearedDate:07‐DEC‐2010BK170004‐0CharterMedical,Ltd.
3948‐AWestpointBlvd.
Winston‐Salem,NC27103TradeName:CharterMedicalCellTherapyFluidTransferSetClearedDate:06‐OCT‐2017BK910003‐0CharterMed,Inc.
3948‐AWestPointBlvd.
Winston‐Salem,NC27103TradeName:CharterMedBloodFreezingBagClearedDate:11‐MAR‐1993BK960043‐0CharterMed,Inc.
3948‐AWestPointBlvd.
Winston‐Salem,NC27103TradeName:CharterMedTransferBagsClearedDate:11‐SEP‐1996BK000049‐0ChironCorporation4560HortonStreetEmeryville,CA94608‐2916TradeName:ChironCPTPoolingSoftware,Version2.
0.
0.
2ClearedDate:04‐DEC‐2001BK010025‐0ChironCorporation4560HortonStreetEmeryville,CA94608‐2916TradeName:ChironProcleixNATTracker‐1.
0EClearedDate:03‐JAN‐2002ClearedUnderRubin&PoorBK030030‐0ChironCorporation4560HortonStreetEmeryville,CA94608‐2916TradeName:ProcleixNATTrackerClearedDate:23‐MAY‐2003ClearedUnderRubin&PoorBK040058‐0ChironCorporation4560HortonStreetEmeryville,CA94608‐2916TradeName:ChironCPTPoolingSoftware,Version2.
0.
0.
2ClearedDate:28‐JUL‐2004BK040072‐0ChironCorporation4560HortonStreetEmeryville,CA94608‐2916TradeName:ProcleixNATTrackerSoftwareVersion2.
1ClearedDate:04‐NOV‐2004BK050004‐0ChironCorporation4560HortonStreetEmeryville,CA94608‐2916TradeName:ProcleixOptivaRASClearedDate:08‐APR‐2005BK060005‐0ChironCorporation4560HortonStreetEmeryville,CA94608‐2916TradeName:ChironProcleixNATTracker‐3.
0ClearedDate:01‐MAR‐2006BK070007‐0ChironCorporation4560HortonStreetEmeryville,CA94608‐2916TradeName:PROCLEIXNATTRACKERClearedDate:06‐MAR‐2007BK980043‐0Chrono‐LogCorporation2WestParkRoadHavertown,PA19083‐4691TradeName:Chrono‐logLumi‐AgrregometerClearedDate:22‐DEC‐1998BK100014‐0CircleBiologics,Inc.
3650AnnapolisLane,Suite105Minneapolis,MN55447TradeName:AutologousFluidConcentrator(AFC)SystemChangedwith6/25/10Submissionto:"AutologousPlateletConcentrator(APC)(TM)SystemClearedDate:09‐JUL‐2010ClearedUnderCircleBiologic,LLCBK840008‐0CobeLaboratories,Inc.
1185OakStreetLakewood,CO80215TradeName:IBM2991‐ChangeofOwnershipClearedDate:08‐JUN‐1984BK840009‐0CobeLaboratories,Inc.
1185OakStreetLakewood,CO80215TradeName:IBM2997‐ChangeofOwnershipClearedDate:08‐JUN‐1984BK870022‐0CobeLaboratories,Inc.
1185OakStreetLakewood,CO80215TradeName:COBESpectraBloodComponentSeparatorClearedDate:20‐JUN‐1988BK900002‐0CobeLaboratories,Inc.
1185OakStreetLakewood,CO80215TradeName:COBESpectra:SimultaneousCollectionofPlatletsandPlasmaClearedDate:21‐JUN‐1990BK900003‐0CobeLaboratories,Inc.
1185OakStreetLakewood,CO80215TradeName:COBESpectra:ChangeinAnticoagulantRatioClearedDate:14‐NOV‐1990BK900004‐0CobeLaboratories,Inc.
1185OakStreetLakewood,CO80215TradeName:COBESpectra:SingleNeedleSystemClearedDate:21‐JUN‐1990BK910020‐0CobeLaboratories,Inc.
1185OakStreetLakewood,CO80215TradeName:COBESPECTRATHERMClearedDate:02‐NOV‐1992BK920011‐0CobeLaboratories,Inc.
1185OakStreetLakewood,CO80215TradeName:CobeSpectrawithPCMClearedDate:15‐MAY‐1995BK920036‐0CobeLaboratories,Inc.
1185OakStreetLakewood,CO80215TradeName:COBESpectraSingle‐NeedleExtendedLifePlatelet(ELP)SetClearedDate:06‐APR‐1993BK930017‐0CobeLaboratories,Inc.
1185OakStreetLakewood,CO80215TradeName:COBESpectraApheresisSystem(TriplePlatelet)ClearedDate:27‐JUL‐1994BK940016‐0CobeLaboratories,Inc.
1185OakStreetLakewood,CO80215TradeName:COBESpectraVersion4ClearedDate:20‐SEP‐1994BK950030‐0CobeLaboratories,Inc.
1185OakStreetLakewood,CO80215TradeName:COBESpectraExtendedLifePlateletSetClearedDate:15‐FEB‐1996BK970007‐0CommunityBio‐Resources,Inc.
2197ParkwayLakeDriveHoover,AL35244TradeName:DonorInformationSystem‐1.
0ClearedDate:09‐APR‐1997BK960060‐0CommunityBloodCenterofGreaterKansasCity4040MainStreetKansasCity,MO64111TradeName:CBCBloodSystem,Version1.
2ClearedDate:20‐NOV‐1997BK110048‐0CommunityBloodCentersofSouthFlorida1700NorthStateRoad7Lauderhill,FL33313TradeName:RegulatedSoftwareApplication(RSA)‐1.
0ClearedDate:12‐JAN‐2012BK920006‐0ConnaughtLaboratoriesLimitedDiscoveryDriveSwiftwater,PA18370TradeName:CONTINENTALREFRIG.
BLD.
BNK.
MODELC‐BBRA‐1SClearedDate:17‐JUL‐1992BK970010‐0ControlledChemicals,Inc.
317S.
DivisionSuite9AnnArbor,MI48104TradeName:CryoGuardThermalExposureIndicatorClearedDate:26‐AUG‐1997BK940026‐0Cook,Inc.
925S.
CurryPikeBloomington,IN47402TradeName:RoubinInfusionCatheterClearedDate:29‐JUN‐1995BK830008‐0CooperBiomedical1230WilsonDriveWestChester,PA19380TradeName:W.
A.
R.
M.
ClearedDate:21‐JUN‐1983BK850008‐0CooperBiomedical1TechnologyCourtMalvern,PA29355TradeName:H.
P.
C.
ClearedDate:09‐JAN‐1986BK820007‐0Cry‐O‐Safe,Inc.
999AirportRoadLakewood,NJ08701TradeName:PlasmaSafeClearedDate:26‐JUL‐1982BK190356‐0Cryo‐CellInternational,Inc.
700BrookerCreekBlvdOldsmar,FL34677TradeName:PrepaCyte‐CBProcessingSystem‐PCB2100‐270ClearedDate:17‐JUN‐2020BK820018‐0CryosanInc.
850ProvidenceHighwayDedham,MA02026TradeName:DidecoBTSeriesClearedDate:16‐DEC‐1982BK820021‐0CryosanInc.
850ProvidenceHighwayDedham,MA02026TradeName:DidecoBT790/ADidecoBT792ClearedDate:03‐JAN‐1983BK830015‐0CryosanInc.
850ProvidenceHighwayDedham,MA02026TradeName:DidecoBT125DidecoBT225DidecoBT375DidecoBT691ClearedDate:31‐OCT‐1983BK830016‐0CryosanInc.
850ProvidenceHighwayDedham,MA02026TradeName:DidecoProgressBT790/AClearedDate:07‐FEB‐1984BK840011‐0CryosanInc.
850ProvidenceHighwayDedham,MA02026TradeName:BT765BloodCellSeparatorEquipmentClearedDate:10‐APR‐1985BK840012‐0CryosanInc.
850ProvidenceHighwayDedham,MA02026TradeName:BT765ElutriationPumpClearedDate:06‐FEB‐1985BK870003‐0CryosanInc.
850ProvidenceHighwayDedham,MA02026TradeName:Cryo‐PakTMSystemClearedDate:17‐APR‐1987BK960012‐0CytoThermLP110SewellAvenueTrenton,NJ08610TradeName:CytoTherm(T‐S)ClearedDate:15‐APR‐1996ClearedUnderPhoto‐ThermBK980042‐0CytoThermLP110SewellAvenueTrenton,NJ08610TradeName:CytoThermJClearedDate:07‐JAN‐1999ClearedUnderPhoto‐ThermBK060027‐0CytoThermLP110SewellAvenueTrenton,NJ08610TradeName:CytoThermPlasmaThawingSystemClearedDate:01‐AUG‐2006BK060063‐0CytoThermLP110SewellAvenueTrenton,NJ08610TradeName:CytoThermCryoprecipitateThawer,ModelCT‐4T.
6CClearedDate:04‐MAY‐2007BK080019‐0CytoThermLP110SewellAvenueTrenton,NJ08610TradeName:CytoThermPlasmaThawingSystemClearedDate:16‐JUL‐2008BK060007‐0Cytomedix,Inc416HungerfordDriveRockville,MD20850TradeName:AutologelSystemClearedDate:20‐SEP‐2007BK110046‐0Cytomedix,Inc416HungerfordDriveRockville,MD20850TradeName:Angel(R)WholeBloodSeparationSystemClearedDate:07‐NOV‐2012BK130060‐0CytonicsCorporation555HeritageDrive,Suite115Jupiter,FL33458TradeName:AutologousPlateletIntegratedConcentration("APIC")SystemClearedDate:17‐JAN‐2014BK950060‐0CytosolLaboratories,Inc.
55MessinaDriveBraintree,MA02184‐6783TradeName:Y‐TypeRejuvenationSetPN7212ClearedDate:25‐NOV‐1996BK000022‐0DENCO,INC.
P.
O.
BOX9600Wilmington,DE19809TradeName:TotalContainmentDeviceClearedDate:18‐APR‐2000BK990041‐0DENCO,INC.
P.
O.
BOX9600Wilmington,DE19809TradeName:TotalContainmentDeviceClearedDate:21‐DEC‐1999BK160084‐0DIAGASTParcEurasanté251,AvenueEugéneAvinéeBP9LOOSCedex,FRANCE59374TradeName:NegControlClearedDate:02‐FEB‐2018BK190313‐0DIAGASTParcEurasanté251,AvenueEugéneAvinéeBP9LOOSCedex,FRANCE59374TradeName:PKSYSTEMCONTROLClearedDate:07‐MAY‐2020BK130053‐0DSMBIOMEDICAL735PennsylvaniaDriveExton,PA19341TradeName:DSMBiomedicalPRPDeviceClearedDate:25‐MAR‐2014BK140176‐0DSMBIOMEDICAL735PennsylvaniaDriveExton,PA19341TradeName:TheJENDeviceClearedDate:06‐MAR‐2015BK950019‐0DUPACO2620TEMPLEHEIGHTSDR.
OCEANSIDE,CA92056TradeName:DUPACOBLOOD/FLUIDWARMINGSETD25416ClearedDate:27‐APR‐1995BK950038‐0DUPACO2620TEMPLEHEIGHTSDR.
OCEANSIDE,CA92056TradeName:DupacoCounterflo300Blood/FluidWarmerClearedDate:01‐SEP‐1995BK020057‐0DataInnovationsLLC120KimballAve.
,Suite100SouthBurlington,VT05430TradeName:imExpress‐7.
2.
5ClearedDate:29‐JUL‐2003ClearedUnderDataInnovationsBK060053‐0DataInnovationsLLC120KimballAve.
,Suite100SouthBurlington,VT05430TradeName:InstrumentManager‐8.
05.
01.
10ClearedDate:05‐JAN‐2007ClearedUnderDataInnovationsInc.
BK080052‐0DataInnovationsLLC120KimballAve.
,Suite100SouthBurlington,VT05430TradeName:INSTRUMENTMANAGER‐V8.
07ClearedDate:28‐OCT‐2008ClearedUnderDataInnovationsInc.
BK100046‐0DataInnovationsLLC120KimballAve.
,Suite100SouthBurlington,VT05430TradeName:InstrumentManager‐8.
10.
01ClearedDate:12‐AUG‐2010ClearedUnderDataInnovationsInc.
BK120051‐0DataInnovationsLLC120KimballAve.
,Suite100SouthBurlington,VT05430TradeName:InstrumentManagerv8.
12ClearedDate:17‐OCT‐2012ClearedUnderDataInnovationsInc.
BK180245‐0DataInnovationsLLC120KimballAve.
,Suite100SouthBurlington,VT05430TradeName:InstrumentManager‐8.
16.
10ClearedDate:08‐NOV‐2018BK070035‐0DefenseBloodStandardSystem5205LeesburgPikeSuite1000FallsChurch,VA22041TradeName:DefenseBloodStandardSystem(DBSS)‐10.
0.
0ClearedDate:22‐MAY‐2008BK180229‐0DelconS.
R.
LViaZanicaGrassobbio,BGITALY24050TradeName:HEMOMIX3HemoMix3withDCSXSoftwareClearedDate:04‐OCT‐2018BK190429‐0DelconS.
R.
LViaZanicaGrassobbio,BGITALY24050TradeName:HemoMix4(Basicversion)HemoMix4(InternaloptionalRFIDinstalledversion)ClearedDate:30‐JAN‐2020BK970021‐0DepartmentofVeteransAffairsP.
O.
Box5000VAHinesMedicalCenterHines,IL60141TradeName:VistaBloodBankSoftware(V5.
2)ClearedDate:23‐APR‐1999BK060043‐0DepartmentofVeteransAffairsP.
O.
Box7008Hines,IL60141‐7008TradeName:VistABloodEstablishmentComputerSoftware(VBECS)‐1.
0ClearedDate:19‐OCT‐2006BK140172‐0DepartmentofVeteransAffairsP.
O.
Box7008Hines,IL60141‐7008TradeName:VistABloodEstablishmentComputerSoftware(VBECS)‐2.
0.
0ClearedDate:20‐NOV‐2014BK180227‐0DepartmentofVeteransAffairsP.
OBox70085thAveandRooseveltRdBldg37Hines,IL60141TradeName:VistABloodEstablishmentComputerSoftware(VBECS)ClearedDate:01‐OCT‐2018BK830025‐0DiaTech2525ShaderRoadOrlando,FL328TradeName:DiaCent2AutomatedCellWasher/CentrifugeClearedDate:10‐JAN‐1984BK840001‐0DiaTech2525ShaderRoadOrlando,FL328TradeName:DIACENT1,AutomatedCellWasher/CentrifugeClearedDate:19‐MAR‐1984BK870007‐0DiaClinLaboratories,Inc.
45010thCircleNorthNashville,TN37203TradeName:SEOPFROPTrayClearedDate:04‐APR‐1990BK120043‐0DiagnosticGrifols,S.
A.
PasseigFluvial,24BarcelonaParetsDelValles,SPAIN08150TradeName:DGGel8NeutralGelClearedDate:19‐JUL‐2013BK120044‐0DiagnosticGrifols,S.
A.
PasseigFluvial,24BarcelonaParetsDelValles,SPAIN08150TradeName:GrifolsDiluentClearedDate:19‐JUL‐2013BK120045‐0DiagnosticGrifols,S.
A.
PasseigFluvial,24BarcelonaParetsDelValles,SPAIN08150TradeName:DGSpinClearedDate:19‐JUL‐2013BK120046‐0DiagnosticGrifols,S.
A.
PasseigFluvial,24BarcelonaParetsDelValles,SPAIN08150TradeName:DGTHERMClearedDate:19‐JUL‐2013BK130025‐0DiagnosticGrifols,S.
A.
PasseigFluvial,24BarcelonaParetsDelValles,SPAIN08150TradeName:WADiana(R)CompactClearedDate:30‐AUG‐2013BK130067‐0DiagnosticGrifols,S.
A.
PasseigFluvial,24BarcelonaParetsDelValles,SPAIN08150TradeName:Erytra(R)ClearedDate:17‐JAN‐2014BK140101‐0DiagnosticGrifols,S.
A.
PasseigFluvial,24BarcelonaParetsDelValles,SPAIN08150TradeName:DGReaderClearedDate:21‐MAY‐2014BK150266‐0DiagnosticGrifols,S.
A.
PasseigFluvial,24BarcelonaParetsDelValles,SPAIN08150TradeName:DGGel(R)8NeutralClearedDate:28‐JUL‐2015BK160100‐0DiagnosticGrifols,S.
A.
PasseigFluvial,24BarcelonaParetsDelValles,SPAIN08150TradeName:DGGel8NeutralClearedDate:09‐NOV‐2016BK170130‐0BK180260‐0BK180262‐0BK190318‐0BK190320‐0BK190321‐0BK190379‐0DiagnosticGrifols,S.
A.
PasseigFluvial,24BarcelonaParetsDelValles,SPAIN08150TradeName:ErytraErytraClearedDate:01‐NOV‐2017DiagnosticGrifols,S.
A.
PasseigFluvial,24BarcelonaParetsDelValles,SPAIN08150TradeName:ErytraEflexisClearedDate:20‐DEC‐2018DiagnosticGrifols,S.
A.
PasseigFluvial,24BarcelonaParetsDelValles,SPAIN08150TradeName:DGGel8NeutralClearedDate:20‐DEC‐2018DiagnosticGrifols,S.
A.
PasseigFluvial,24BarcelonaParetsDelValles,SPAIN08150TradeName:ErytraClearedDate:10‐DEC‐2019DiagnosticGrifols,S.
A.
PasseigFluvial,24BarcelonaParetsDelValles,SPAIN08150TradeName:DGReaderClearedDate:10‐DEC‐2019DiagnosticGrifols,S.
A.
PasseigFluvial,24BarcelonaParetsDelValles,SPAIN08150TradeName:WADianaCompactClearedDate:10‐DEC‐2019DiagnosticGrifols,S.
A.
PasseigFluvial,24BarcelonaParetsDelValles,SPAIN08150TradeName:DGReaderNetClearedDate:11‐OCT‐2019BK200467‐0DiagnosticGrifols,S.
A.
PasseigFluvial,24BarcelonaParetsDelValles,SPAIN08150TradeName:ErytraEflexisClearedDate:23‐APR‐2020BK110036‐0DiaspectMedicalGMBH800E.
LeighStreetSuite206‐5Richmond,VA23219TradeName:DiaSpectHemoglobinTandDiaSpectHemoglobinCuvettesClearedDate:01‐NOV‐2011BK120052‐0DiaspectMedicalGMBH800E.
LeighStreetSuite206‐5Richmond,VA23219TradeName:DiaSpectControlHBT(‐L,‐M.
‐H)ClearedDate:14‐NOV‐2012BK970013‐0Digi‐TraxCorporation1550BarclayBoulevardBuffaloGrove,IL60089TradeName:Donor‐IDClearedDate:27‐FEB‐1998BK000020‐0Digi‐TraxCorporation1550BarclayBoulevardBuffaloGrove,IL60089TradeName:Digi‐TraxDonor‐ID‐2.
0ClearedDate:20‐APR‐2000BK010049‐0Digi‐TraxCorporation1550BarclayBoulevardBuffaloGrove,IL60089TradeName:Donor‐ID‐2.
2ClearedDate:26‐APR‐2002BK850006‐0DivisionofImmunologicOncology3900ReservoirRd.
,NW,Box63,Med‐DenBldWashington,DC20007TradeName:GTUDR/DQTypingTrayClearedDate:25‐APR‐1985BK980009‐0DominionBiologicalsLimited5IsnorDriveDartmouth,NovaScotiaCANADAB3B1M1TradeName:CoombsControlCells(IgGCoated)ClearedDate:30‐OCT‐1998BK070065‐0DuleyHopkinsandAssociates1200MountainCreekRoad#215Chattanooga,TN37405TradeName:BloodBankInformationManagementSystem(BBIMS)‐V2.
05.
01ClearedDate:25‐APR‐2008BK090079‐0DuleyHopkinsandAssociates1200MountainCreekRoad#215Chattanooga,TN37405TradeName:BloodBankInformationManagementSystem(BBIMSV2.
05.
01)ClearedDate:13‐JAN‐2010BK030056‐0DynalBiotechLtd11BassendaleRoadCroftBusinesParkBromborough,Wirral,CH623QL,UNITEDKINGDOMTradeName:DynalReliSSOHLA‐ATypingKitClearedDate:29‐JAN‐2004BK030057‐0DynalBiotechLtd11BassendaleRoadCroftBusinesParkBromborough,Wirral,CH623QL,UNITEDKINGDOMTradeName:DynalReliSSOHLA‐BTypingKitClearedDate:29‐JAN‐2004BK030058‐0DynalBiotechLtd11BassendaleRoadCroftBusinesParkBromborough,Wirral,CH623QL,UNITEDKINGDOMTradeName:DYNALRELISSOHLA‐CwTypingKitClearedDate:29‐JAN‐2004BK030059‐0DynalBiotechLtd11BassendaleRoadCroftBusinesParkBromborough,Wirral,CH623QL,UNITEDKINGDOMTradeName:DynalRELISSOHLA‐DQB1TypingKitClearedDate:29‐JAN‐2004BK030060‐0DynalBiotechLtd11BassendaleRoadCroftBusinesParkBromborough,Wirral,CH623QL,UNITEDKINGDOMTradeName:DYNALRELISSOHLA‐DRBTypingSystem.
ClearedDate:29‐JAN‐2004BK050012‐0DynalBiotechLtd11BassendaleRoadCroftBusinesParkBromborough,Wirral,CH623QL,UNITEDKINGDOMTradeName:DynalRELISSOHLA‐DRB1TypingKit‐ForUseasamanualasssayorwiththeAutoRELIInstrumentClearedDate:18‐MAY‐2005BK960041‐0DynamicHealthcareTechnologies,Inc.
101SouthhallLane,Suite210Maitland,FL32751TradeName:TransfusionServiceMgr.
ClearedDate:16‐DEC‐1997BK840004‐0DynatechLaboratories,Inc.
900SlatersLaneAlexandria,VA22314TradeName:MicroBBank220AutomatedMicroplateReaderClearedDate:18‐MAY‐1984BK850013‐0DynatechLaboratories,Inc.
900SlatersLaneAlexandria,VA22314TradeName:MicroBankSystemClearedDate:08‐OCT‐1985BK840003‐0E.
I.
duPontdeNemours&CompanyMedicalProductsDepartmentWilmington,DE19898TradeName:DuPontSCDClearedDate:07‐NOV‐1984BK910022‐0E.
I.
duPontdeNemours&CompanyMedicalProductsDepartmentWilmington,DE19898TradeName:DuPontSorvallRC3BPlusDuPontSorvallRC3CPlusCentrifugeClearedDate:21‐JAN‐1992BK840018‐0EKIndustries,Inc.
411KayAvenueAddison,IL60101TradeName:CopperSulfateSolution(forwomen)ClearedDate:11‐DEC‐1984BK840019‐0EKIndustries,Inc.
411KayAvenueAddison,IL60101TradeName:CopperSulfateSolution(formen)ClearedDate:11‐DEC‐1984BK200520‐0EKF‐diagnosticGmbHEbendorferChaussee3,BarlebenGERMANY39179TradeName:DiaSpectTMSystemDiaSpectTmDiaSpectTmCuvettesDiaSpectTMsysterClearedDate:24‐NOV‐2020BK170138‐0ETHICONInc.
Route22WestP.
O.
Box151Somerville,NJ08876TradeName:EVICELLaparoscopicAirlessSprayAccessory(35cmRigid)ClearedDate:26‐JAN‐2018BK180287‐0ETHICONInc.
Route22WestP.
O.
Box151Somerville,NJ08876TradeName:VISTASEALAirlessSprayAccessoryClearedDate:10‐APR‐2019BK190324‐0ETHICONInc.
Route22WestP.
O.
Box151Somerville,NJ08876TradeName:VISTASEALLaparoscopicDualApplicator(35cmRigidor45cmFlexible)VISTASEALLaparoscopicDualApplicator(35emRigidor45emFlexible)ClearedDate:05‐JUN‐2019BK090044‐0EclypsisCorporation450LappRoadMalvern,PA19355TradeName:SunriseBloodBankversion2.
0SP2ClearedDate:13‐NOV‐2009BK900006‐0ElectroluxSARL1317FSt.
NW,suite150Washington,DC20004TradeName:BloodChainThermostabilizerRCB42PClearedDate:18‐JUL‐1990BK190317‐0EmCyteCorporation4331VeronicaSouthShoemakerBlvdForMyers,FL33916TradeName:PurePRPSupraPhysiologicConcentratingSystemClearedDate:12‐FEB‐2020BK860018‐0Engineering&ResearchAssociates,Inc.
500NorthTucsonBoulevard(ERAPlaza)Tucson,AZ85716TradeName:SEBRAModel1150(BloodWeigthMonitor)ClearedDate:11‐JUL‐1986BK860019‐0Engineering&ResearchAssociates,Inc.
500NorthTucsonBoulevard(ERAPlaza)Tucson,AZ85716TradeName:SEBRAModel1300(TubeStripper)ClearedDate:29‐SEP‐1986BK870023‐0Engineering&ResearchAssociates,Inc.
500NorthTucsonBoulevard(ERAPlaza)Tucson,AZ85716TradeName:SebraModel#1500CentrifugeCupBloodBagHolderClearedDate:25‐SEP‐1986BK900025‐0Engineering&ResearchAssociates,Inc.
500NorthTucsonBoulevard(ERAPlaza)Tucson,AZ85716TradeName:SEBRAModel#2470,MobileTubeSealerClearedDate:26‐JUN‐1991BK900026‐0Engineering&ResearchAssociates,Inc.
500NorthTucsonBoulevard(ERAPlaza)Tucson,AZ85716TradeName:SEBRAMODEL#1040,DIGITALBLOODSHAKER/WEIGHTMONITORClearedDate:26‐JUN‐1991BK900029‐0Engineering&ResearchAssociates,Inc.
500NorthTucsonBoulevard(ERAPlaza)Tucson,AZ85716TradeName:SebraModel#2390,MobileTubeSealerClearedDate:26‐JUN‐1991BK910015‐0Engineering&ResearchAssociates,Inc.
500NorthTucsonBoulevard(ERAPlaza)Tucson,AZ85716TradeName:SebraModel#1290,Blood/PlateletCoolantClearedDate:11‐SEP‐1991BK910024‐0Engineering&ResearchAssociates,Inc.
500NorthTucsonBoulevard(ERAPlaza)Tucson,AZ85716TradeName:SEBRA/MODEL#2100TUBESEALERClearedDate:05‐NOV‐1992BK910025‐0Engineering&ResearchAssociates,Inc.
500NorthTucsonBoulevard(ERAPlaza)Tucson,AZ85716TradeName:SEBRAMODEL1440BLD.
SHAKER/WT.
MONITORClearedDate:05‐NOV‐1992BK910026‐0Engineering&ResearchAssociates,Inc.
500NorthTucsonBoulevard(ERAPlaza)Tucson,AZ85716TradeName:SEBRA/MODEL2590HANDHELDTUBESEALERClearedDate:05‐NOV‐1992BK130037‐0EpicSystemsCorporation1979MilkyWayVerona,WI53593TradeName:BloodProductAdministrationModuleversion0.
9ClearedDate:06‐MAR‐2014BK170032‐0EpicSystemsCorporation1979MilkyWayVerona,WI53593TradeName:BloodProductAdministrationModule,Version2‐2017ClearedDate:28‐JUN‐2017BK200482‐0EpicSystemsCorporation1979MilkyWayVerona,WI53593TradeName:BloodProductAdministrationModuleClearedDate:10‐JUN‐2020BK110035‐0EstarTechnologiesLTD420LexingtonAvenueSuite2400NewYork,NY10170TradeName:TropoCellsAutologousPlateletPreparationKitClearedDate:28‐MAR‐2012BK920002‐0EthoxCorp.
251SenecaSt,Buffalo,NY14204TradeName:EthoxTransferPackClearedDate:17‐SEP‐1992BK830010‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:TransferPackUnit(s)withSterileConnectorClearedDate:23‐AUG‐1988ClearedUnderTravenolLaboratoriesBK830011‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:ClosedApheresisKitforExtendedPlateletStorageClearedDate:27‐MAY‐1983ClearedUnderTravenolLaboratoriesBK830009‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:Plasma‐GardClearedDate:25‐JAN‐1984ClearedUnderTravenolLaboratoriesBK860015‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:ApheresisKit/ExtendedPlate.
Stor.
&Plas.
Coll.
ClearedDate:03‐JUL‐1986ClearedUnderTravenolLaboratoriesBK860029‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:IsoradialSeparationChamberClearedDate:28‐NOV‐1986ClearedUnderTravenolLaboratoriesBK860035‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:CS‐3000BldCellSeparatorBldSampleContainersClearedDate:26‐FEB‐1987ClearedUnderTravenolLaboratoriesBK870017‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:FenwalLS‐300CentrifugeClearedDate:16‐NOV‐1987ClearedUnderFenwalLaboratoriesBK880023‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:FenualCS3000BloodCellSeparatorClearedDate:13‐JUN‐1989ClearedUnderTravenolLaboratoriesBK900005‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:ClosedSystemApheresisKit‐CS3000BloodCellSeparatorClearedDate:05‐JUN‐1990ClearedUnderBaxterHealthcareCorporationBK900016‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:ClosedSystemApheresisKitCS‐3000BloodCellSeparator(singlevenousaccessforplateletcollection)ClearedDate:07‐JUN‐1991ClearedUnderBaxterHealthcareCorporationBK900020‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:OptumPlateletSeparationChamberClearedDate:07‐NOV‐1990ClearedUnderBaxterHealthcareCorporationBK910014‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:SepacellR‐200;Pre‐StorageLeukocyteDepletionSetforRedBloodClearedDate:18‐SEP‐1991ClearedUnderBaxterHealthcareCorporationBK910032‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:OptiPressClearedDate:03‐JUN‐1993ClearedUnderBaxterHealthcareCorporationBK920003‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:FenwalNeedle/TubeSamplingProtector/SafetyCoverClearedDate:12‐MAR‐1992ClearedUnderBaxterHealthcareCorporationBK920029‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:30‐mLCollectionChamberforCS‐3000PlusBloodCellSeparatorClearedDate:06‐MAY‐1994ClearedUnderBaxterHealthcareCorporationBK920032‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:SepacellPre‐storageLeukocyteDepletionSetforRedCellClearedDate:07‐JUN‐1993ClearedUnderBaxterHealthcareCorporationBK920038‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:ClosedSystemApheresisKitwithIntegralLeukocyteRemovalFilterClearedDate:27‐JUL‐1994ClearedUnderBaxterHealthcareCorporationBK930029‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:AccessTMManagementSystem(AMS)ClearedDate:20‐JUN‐1994ClearedUnderBaxterHealthcareCorporationBK940005‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:FenwalBoneMarrowCollectionKitw/FlexiblePre‐filterandInlineFiltersandFenwalBoneMarrowCollectionStandClearedDate:18‐MAY‐1994ClearedUnderBaxterHealthcareCorporationBK940009‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:OptipressTMAutomatedBloodComponentClearedDate:18‐MAY‐1994ClearedUnderBaxterHealthcareCorporationBK940013‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:ExStoragePL732Containersw/SepacellFilterforLeukocytesReducedPlateletsClearedDate:27‐JUL‐1994ClearedUnderBaxterHealthcareCorporationBK940023‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:AccessoryWeightScaleforMedicalPurposesClearedDate:05‐JUL‐1994ClearedUnderBaxterHealthcareCorporationBK940036‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:StorageContainersforCS‐3000ApheresisKitClearedDate:27‐DEC‐1994ClearedUnderBaxterHealthcareCorporationBK940040‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:SepacellPLS‐10A,5ALeukocyteReductionFilterPlateletProductsClearedDate:28‐FEB‐1995ClearedUnderBaxterHealthcareCorporationBK940041‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:SepacellR‐2000PrestorageLeukocyteReductionSetforRedBloodCellsClearedDate:14‐FEB‐1995ClearedUnderBaxterHealthcareCorporationBK950013‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:CS‐3000Plus(mononeuclearcells)ClearedDate:12‐NOV‐2002ClearedUnderBaxterHealthcareCorporationBK950016‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:PallBPF4LeukocyteReductionSetforRBCClearedDate:20‐SEP‐1995ClearedUnderBaxterHealthcareCorporationBK950023‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:CS‐3000BloodCellSeparatorApheresisKitClearedDate:29‐JUN‐1995ClearedUnderBaxterHealthcareCorporationBK960005‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:AmicusSeparatorClearedDate:19‐DEC‐1996ClearedUnderBaxterHealthcareCorporationBK960083‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:HematypeSegmentDeviceClearedDate:28‐FEB‐1997ClearedUnderMedicalSafetyProducts,Inc.
BK980041‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:SepacellPre‐StorageLeukocyteReductionSetforRedCellsClearedDate:16‐JUL‐1999ClearedUnderBaxterHealthcareCorporationBK990009‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:FenwalAmicusSeparatorCollectionofThreePlateletProductsClearedDate:03‐MAR‐2000ClearedUnderBaxterHealthcareCorporationBK000039‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:AmicusSeparator,ConcurrentCollectionofRedBloodCellsClearedDate:26‐AUG‐2002ClearedUnderBaxterHealthcareCorporationBK000047‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:AmicusSeparator,MononuclearCellCollectionClearedDate:31‐JUL‐2002ClearedUnderBaxterHealthcareCorporationBK010016‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:ApheresisDataIntegrationSystem(ADIS)ClearedDate:04‐DEC‐2001ClearedUnderBaxterHealthcareCorporationBK010033‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:CygnetSystemClearedDate:27‐AUG‐2002ClearedUnderBaxterHealthcareCorporationBK020008‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:LeukoConnect‐Pre‐StorageSterileConnectLeukoreductionSetwithSepacellFilterforRedBloodCellsClearedDate:10‐DEC‐2002ClearedUnderBaxterHealthcareCorporation‐I.
V.
SystemsDivisionBK020056‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:ALYXSystemClearedDate:20‐DEC‐2002ClearedUnderBaxterHealthcareCorporationBK030085‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:ALYXComponentCollectionSystemandAmicusSeparatorSystemClearedDate:15‐MAR‐2004ClearedUnderBaxterHealthcareCorporationBK040059‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:AmicusSeparatorSystemClearedDate:24‐SEP‐2004ClearedUnderBaxterHealthcareCorporation‐TransfusionTherapiesDivisionBK040084‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:ALYXComponentCollectionSystemClearedDate:15‐MAR‐2005ClearedUnderBaxterHealthcareCorporationBK050020‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:LeukoConnect‐Pre‐StorageSterileConnectLeukoreductionSetwithSepacellFilterforRedBloodCellsinadditivesolutionClearedDate:17‐MAY‐2005ClearedUnderBaxterHealthcareCorporationBK050038‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:AMICUSSeparatorSystemClearedDate:03‐NOV‐2005ClearedUnderBaxterHealthcareCorporationBK060061‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:ALYXComponentCollectionSystem:ALYX2RBC‐NLRKitClearedDate:09‐FEB‐2007ClearedUnderBaxterHealthcareCorporationBK080024‐0FenwalIncThreeCorporateDrive2ndFloorLakeZurich,IL60047TradeName:ALYXComponentCollectionSystemClearedDate:24‐JUN‐2008BK080048‐0FenwalIncThreeCorporateDrive2ndFloorLakeZurich,IL60047TradeName:AMICUSSeparatorClearedDate:02‐OCT‐2008BK080053‐0FenwalIncThreeCorporateDrive2ndFloorLakeZurich,IL60047TradeName:ALYXComponentCollectionSystemClearedDate:22‐DEC‐2008BK090031‐0FenwalIncThreeCorporateDrive2ndFloorLakeZurich,IL60047TradeName:BoneMarrowCollectionKitandAccessoriesClearedDate:23‐JUL‐2009BK090058‐0FenwalIncThreeCorporateDrive2ndFloorLakeZurich,IL60047TradeName:AMICUSSeparatorSystemClearedDate:18‐FEB‐2010BK090065‐0FenwalIncThreeCorporateDrive2ndFloorLakeZurich,IL60047TradeName:AMICUSSeparatorSystemClearedDate:04‐MAR‐2010BK100041‐0FenwalIncThreeCorporateDrive2ndFloorLakeZurich,IL60047TradeName:Autopheresis‐CPlasmapheresisSystemClearedDate:14‐SEP‐2017BK100050‐0FenwalIncThreeCorporateDrive2ndFloorLakeZurich,IL60047TradeName:Autopheresis‐CPlasmapheresissystemClearedDate:16‐NOV‐2010BK100056‐0FenwalIncThreeCorporateDrive2ndFloorLakeZurich,IL60047TradeName:ALYXComponentCollectionSystemClearedDate:07‐DEC‐2010BK110025‐0FenwalIncThreeCorporateDrive2ndFloorLakeZurich,IL60047TradeName:Software,BloodBan,StandAloneClearedDate:22‐AUG‐2011BK110030‐0FenwalIncThreeCorporateDrive2ndFloorLakeZurich,IL60047TradeName:AMICUSSeparatorSystemwithSoftwareVersion4.
3ClearedDate:23‐DEC‐2011BK110066‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:ProductSamplePackClearedDate:27‐FEB‐2012BK110072‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:AuroraPlasmapheresisSystemPlasmacell‐CDisposableSetClearedDate:29‐MAR‐2012BK120082‐0FenwalIncThreeCorporateDrive2ndFloorLakeZurich,IL60047TradeName:AMICUSApheresisKitsAMICUSSeparatorSystemClearedDate:08‐JAN‐2013BK130004‐0FenwalIncThreeCorporateDrLakeZurich,IL60047TradeName:AlyxComponentCollectionSystemClearedDate:11‐SEP‐2013BK150236‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:Alyx2RBCClosedDisposableApheresisKitAlyxComponentCollectionSystem(AlyxClassic)AlyxComponentCollectionSystem(AlyxbyFenwal)ClearedDate:22‐APR‐2015BK170001‐0FenwalIncThreeCorporateDrLakeZurich,IL60047TradeName:AlyxComponentCollectionSystem(AlyxClassic)AlyxComponentCollectionSystem(AlyxbyFenwal)AlyxComponentCollectionSystem(FreseniusKabi)ClearedDate:03‐APR‐2017BK200475‐0FenwalIncThreeCorporateDriveLakeZurich,IL60047TradeName:ALYXComponentCollectionSystemClearedDate:10‐JUN‐2020BK920026‐0Fenwal,Inc.
25212W.
IllinoisRoute120,RLP‐34RoundLake,Il60073RoundLake,IL60073TradeName:SDPMicroplateAssayManagementSoftwareClearedDate:30‐JUL‐1993ClearedUnderGeneticSystemsCorporationBK080018‐0Fenwal,Inc.
ThreeCorporateDriveLakeZurich,IL60047TradeName:AmicusSeparatorSystemClearedDate:26‐AUG‐2008ClearedUnderFenwalBloodTechnologiesBK080033‐0Fenwal,Inc.
ThreeCorporateDriveLakeZurich,IL60047TradeName:PLASMALINKClearedDate:22‐AUG‐2008ClearedUnderFenwalBloodTechnologiesBK100044‐0Fenwal,Inc.
ThreeCorporateDriveLakeZurich,IL60047TradeName:AmicusSeparatorSystemClearedDate:30‐JUL‐2010ClearedUnderFenwalBloodTechnologiesBK120018‐0Fenwal,Inc.
ThreeCorporateDriveLakeZurich,IL60047TradeName:AMICUSApheresisKitsAMICUSSeparatorSystemClearedDate:20‐JUL‐2012BK120041‐0Fenwal,Inc.
ThreeCorporateDriveLakeZurich,IL60047TradeName:ALYXComponentCollectionSystemAMICUSSeparatorSystemClearedDate:03‐OCT‐2012BK120047‐0Fenwal,Inc.
ThreeCorporateDriveLakeZurich,IL60047TradeName:Autopheresis‐CPlasmapheresisSystemPlasmacell‐CSetClearedDate:18‐DEC‐2012BK130030‐0Fenwal,Inc.
ThreeCorporateDriveLakeZurich,IL60047TradeName:AlyxComponentCollectionSystem(AlyxClassic)AlyxComponentCollectionSystem(AlyxbyFenwal)AlyxPlasmaKitClearedDate:01‐NOV‐2013BK180296‐0FidiaFarmaceuticiS.
p.
A.
ViaPontedellaFabbrica3/A,AbanoTerme,PaduaITALY35031TradeName:FidiaPRPKitFidiaPRPKit‐20mLFidiaPRPKit‐50mLClearedDate:05‐NOV‐2019BK190401‐0FremonScientificInc5726LaJollaBlvdLaJolla,CA92037TradeName:ZipThaw202ClearedDate:18‐DEC‐2019BK160042‐0FreseniusKabiThreeCorporateDriveLakeZurich,IL60047TradeName:BoneMarrowCollectionKitandStandClearedDate:09‐JUN‐2016BK170030‐0FreseniusKabiThreeCorporateDriveLakeZurich,IL60047TradeName:BoneMarrowCollectionKitwithFlexiblePre‐FilterandInlineFiltersBoneMarrowCollectionStandClearedDate:24‐JUL‐2017BK160012‐0FreseniusKabiAGElse‐Kroner‐Strasse1BadHomburg,GERMANY61346TradeName:AuroraPlasmapheresisSystem,SoftwareVersion1.
3ClearedDate:19‐MAY‐2016BK160028‐0FreseniusKabiAGThreeCorporateDrLakeZurich,IL60047TradeName:AuroraXiPlasmapheresisSystemClearedDate:21‐SEP‐2016BK170057‐0FreseniusKabiAGThreeCorporateDrLakeZurich,IL60047TradeName:AuroraXiPlasmapheresisSystem/AuroraXi/AuroraXisystem/AuroraXiSoftwareVersion1.
1ClearedDate:25‐AUG‐2017BK170072‐0FreseniusKabiAGThreeCorporateDrLakeZurich,IL60047TradeName:DXTDataManagementSystemClearedDate:26‐SEP‐2017BK180230‐0FreseniusKabiAGThreeCorporateDrLakeZurich,IL60047TradeName:DXTDataManagementSystem‐3.
1ClearedDate:14‐AUG‐2018BK180254‐0FreseniusKabiAGThreeCorporateDrLakeZurich,IL60047TradeName:Glycerolyte57Solution,400mLGlycerolyte57Solution,500mLClearedDate:03‐DEC‐2018BK180268‐0FreseniusKabiAGThreeCorporateDrLakeZurich,IL60047TradeName:AuroraXIPlasmapheresisSystem/AuroraXISystem/AuroraXI‐1.
2ClearedDate:02‐NOV‐2018BK180293‐0FreseniusKabiAGThreeCorporateDrLakeZurich,IL60047TradeName:PlasmalinkBottlewithLockingLuerAdapterClearedDate:21‐DEC‐2018BK190362‐0FreseniusKabiAGThreeCorporateDrLakeZurich,IL60047TradeName:PlasmalinkBottlewithLockingLuerAdapterClearedDate:19‐JUL‐2019BK190368‐0FreseniusKabiAGElse‐Kroner‐Strasse1BadHomburg,GERMANY61346TradeName:AuroraPlasmapheresisSystem/Aurora/Aurorasystem/AuroraSoftwareVersion2.
1/Aurora2.
1‐2.
1AuroraSoftwareVersion2.
1UpgradeKit/AuroraUpgradeKit‐2.
1ClearedDate:26‐JUL‐2019BK190413‐0FreseniusKabiAGElse‐Kroner‐Strasse1,BadHomburgGERMANY61352TradeName:CompoMasterNetG5Plus‐9026551CompoMatG5Plus‐9026561ClearedDate:06‐FEB‐2020BK190421‐0FreseniusKabiAGElse‐Kroner‐Strasse1BadHomburg,GERMANY61346TradeName:FenwalPlasmalinkTransferPackContainerwithLuerAdapterandNoOutletFenwalPlasmalinkTransferPackContainerwithLuerAdapterandNoOutletPorts‐4R2088PClearedDate:11‐MAR‐2020BK200478‐0FreseniusKabiAGElse‐Kroner‐Strasse1BadHomburg,GERMANY61346TradeName:AuroraXiPlasmapheresisSystem/AuroraXi/AuroraXisystem/AuroraXi‐1.
2ClearedDate:07‐MAY‐2020BK110012‐0FreseniusKabiUSALLC.
ThreeCorporateDriveLakeZurich,IL60047TradeName:CompoMatG5andCompoMasterNetG5SystemClearedDate:02‐AUG‐2012ClearedUnderfreseniusKabi,LLC.
BK150242‐0FreseniusKabiUSALLC.
ThreeCorporateDriveLakeZurich,IL60047TradeName:AmicusSeparatorSystemClearedDate:22‐JUL‐2015BK150288‐0FreseniusKabiUSALLC.
ThreeCorporateDriveLakeZurich,IL60047TradeName:AMICUSApheresisKitsAMICUSApheresisSystemClearedDate:28‐AUG‐2015BK150357‐0FreseniusKabiUSALLC.
ThreeCorporateDriveLakeZurich,IL60047TradeName:AMICUSApheresisKits(Model#4R4580,4R4580R)AMICUSSeparatorSystem(Model#4R2353,4R2354)ClearedDate:20‐APR‐2016BK160112‐0FreseniusKabiUSALLC.
ThreeCorporateDriveLakeZurich,IL60047TradeName:AMICUSSeparatorSystemClearedDate:07‐APR‐2017BK170099‐0FreseniusKabiUSALLC.
ThreeCorporateDriveLakeZurich,IL60047TradeName:AMICUSSeparatorSystemAMICUSSeparatorSystem;RefurbishedClearedDate:10‐OCT‐2017BK190351‐0FreseniusKabiUSALLC.
ThreeCorporateDriveLakeZurich,IL60047TradeName:ALYX2RBCLRKitALYXComponentCollectionSystemALYXRBC/PlasmaKitALYXRedKitClearedDate:06‐JUN‐2019BK030022‐0FreseniusMedicalCareNorthAmerica6675185thAvenueNESuite100Redmond,WA98052TradeName:FreseniusCompomatG4&CompomasterNTClearedDate:11‐JUL‐2003ClearedUnderFreseniusHemocareInc.
BK040005‐0FreseniusMedicalCareNorthAmerica95HaydenAvenueLexington,MA02420‐9192TradeName:FreseniusCompoguard&DonationmasterNTClearedDate:26‐MAR‐2004ClearedUnderFreseniusHemocareInc.
BK040076‐0FreseniusMedicalCareNorthAmerica95HaydenAvenueLexington,MA02420‐9192TradeName:CompodockClearedDate:17‐DEC‐2004ClearedUnderFreseniusHemocareInc.
BK880007‐0FreseniusUSA/SeratronicsInc.
2637ShadelandsDriveWalnutCreek,CA94598TradeName:FreseniusAS104CellSeparatorClearedDate:22‐JUL‐1996BK880018‐0FreseniusUSA/SeratronicsInc.
4090PikeLaneConcord,CA94502TradeName:AstothermIFT200;IFT220ClearedDate:25‐AUG‐1988BK960066‐0FrigidaireCommercialProductsCompany707RobinsStConway,AR72032TradeName:EagleSeriesBloodStorageRefrigerator#ST30RGBBandST50ClearedDate:30‐AUG‐1996BK960092‐0FujirebioAmericaInc.
30TwoBridgesRoadSuite250Fairfield,NJ07004TradeName:OlympusPKCMV‐PASystem&ControlsClearedDate:28‐OCT‐1998BK960070‐0FujirebioDiagnostics,Inc201GreatValleyParkwayMalvern,PA19355TradeName:OlympusPK‐TPSystemControlSetClearedDate:19‐JUN‐1997ClearedUnderSCIMEDXCorporationBK200476‐0FujirebioDiagnostics,Inc201GreatValleyParkwayMalvern,PA19355TradeName:PKCMV‐PASystemPKCMV‐PASystemControlSetClearedDate:19‐OCT‐2020BK030007‐0FujirebioDiagnostics,Inc.
201GreatValleyParkwayMalvern,PA19355TradeName:OlympusPKTPSystemClearedDate:21‐FEB‐2003BK060062‐0FujirebioDiagnostics,Inc.
201GreatValleyParkwayMalvern,PA19355TradeName:OlympusPKTPReagentSystemClearedDate:25‐JUN‐2007BK070030‐0FujirebioDiagnostics,Inc.
201GreatValleyParkwayMalvern,PA19355TradeName:OlympusPKCMV‐PATestSystemandControlsOlympusPK7300AutomatedBloodBankAnalyzerClearedDate:20‐SEP‐2007BK940047‐0Fujirebio,Inc.
1129BloomfieldAve,WestCaldwell,NJ07006TradeName:OlympusPKTPSystemReactiveControlClearedDate:29‐NOV‐1995BK920005‐0Futuremed2076DeerParkAvenueDeerPark,NY11729TradeName:AM‐4ClearedDate:29‐SEP‐1994BK940055‐0Futuremed2076DeerParkAvenueDeerPark,NY11729TradeName:LFusionBagsforWarmingBlood/Plasmaw/ANIMEC4ClearedDate:27‐DEC‐1994BK050018‐0GEMedicalInformationTechnologies540NorthwestHighwayBarrington,IL60010TradeName:CentricityUltraLaboratoryTransfusionMedicine(UltraTM)‐4.
0ClearedDate:13‐JUN‐2005BK870024‐0GambroInc.
23872KelseyRoadBarrington,IL60010TradeName:GambroWeldingDeviceWD2ClearedDate:02‐NOV‐1987BK820017‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:Omni‐SeriesControlClearedDate:21‐JAN‐1983BK830012‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaOmniCoombsControlCellsClearedDate:13‐JUN‐1983BK830014‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:Elu‐KitIIClearedDate:25‐NOV‐1983BK830019‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaMicrotearSystemClearedDate:21‐SEP‐1983BK830026‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaMicro‐UPlateClearedDate:08‐DEC‐1983BK850001‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaSTS‐MClearedDate:05‐APR‐1985BK850002‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaSTSRedCellDiluentClearedDate:05‐APR‐1985BK850005‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaSTS‐AClearedDate:03‐OCT‐1986BK850019‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaMicro‐UAccessoryEquipment(TimerDevice)ClearedDate:20‐MAR‐1986BK850020‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaMicro‐UAccessoryEquipmentClearedDate:20‐MAR‐1986BK850021‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaMicro‐UAccessoryEquipmentClearedDate:20‐MAR‐1986BK850024‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaMicro‐UCoombsWashSolutionClearedDate:20‐MAR‐1986BK850025‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaMicro‐UEnhancementReagentClearedDate:20‐MAR‐1986BK860024‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaN‐HANCEClearedDate:26‐AUG‐1986BK880016‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaZyme‐BClearedDate:25‐AUG‐1988BK900021‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:Gamma‐cloneControlClearedDate:26‐OCT‐1990BK910001‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaPegClearedDate:24‐MAR‐1992BK930026‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaRQC‐KitClearedDate:16‐NOV‐1993BK960055‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:CoombsControlCells(EIgG)StrongClearedDate:23‐OCT‐1996BK960056‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:CoombsControlCells(EIgG)WeakClearedDate:23‐OCT‐1996BK960077‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaRe‐ACTCentrifugeClearedDate:18‐SEP‐1997BK960078‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaReACTIncubatorClearedDate:18‐SEP‐1997BK960079‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaReACTAntibodyDetectionStripsClearedDate:18‐SEP‐1997BK960080‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaReACTDiluentClearedDate:18‐SEP‐1997BK960081‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaReACTControlCells(EIgG)ClearedDate:18‐SEP‐1997BK960090‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:GammaEGAKitClearedDate:21‐JUL‐1997BK970002‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:Gamma‐ReACTworkstationClearedDate:30‐MAY‐1997BK970003‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:Gamma‐ReACTReaderClearedDate:30‐MAY‐1997BK970047‐0GammaBiologicals,Inc.
3700MangumRoadHouston,TX77092TradeName:OlympusSystemControlReagentClearedDate:11‐DEC‐1998BK060050‐0GaymarIndustries,Inc.
1700PennsylvaniaAvenue,N.
W.
Washington,DC20006‐4706TradeName:Medi‐TempIII,ModelFW600Blood/FluidWarmerClearedDate:07‐NOV‐2006BK950002‐0GenTrak,Inc.
5100CampusDr.
PlymouthMeeting,NJ19462TradeName:CQuentialsDRDNATypingKitClearedDate:15‐MAY‐1995BK000051‐0Gen‐Probe10210GeneticCenterDriveSanDiego,CA92121‐4362TradeName:TheChironProcleixSystemClearedDate:08‐FEB‐2002BK010003‐0Gen‐Probe10210GeneticCenterDriveSanDiego,CA92121‐4362TradeName:CHironProcleixHIV‐1/HCVControlsClearedDate:22‐FEB‐2002BK010005‐0Gen‐Probe10210GeneticCenterDriveSanDiego,CA92121‐4362TradeName:ChironProcleixHIV/HCVProficiencyPanelClearedDate:01‐OCT‐2001BK020045‐0Gen‐Probe10210GeneticCenterDriveSanDiego,CA92121‐4362TradeName:ChironProcleixSystemClearedDate:21‐NOV‐2002BK050007‐0Gen‐Probe10210GeneticCenterDriveSanDiego,CA92121‐4362TradeName:ProcleixSystemClearedDate:29‐APR‐2005BK050042‐0Gen‐Probe10210GeneticCenterDriveSanDiego,CA92121‐4362TradeName:ProcleixSystemfortheProcleixWNVAssayClearedDate:15‐NOV‐2005BK060012‐0Gen‐Probe10210GeneticCenterDriveSanDiego,CA92121‐4362TradeName:ProcleixSystemClearedDate:15‐MAR‐2006BK060021‐0Gen‐Probe10210GeneticCenterDriveSanDiego,CA92121‐4362TradeName:ProcleixTIGRISSystemforusewiththeProcleixWNVAssayClearedDate:20‐FEB‐2007BK110002‐0Gen‐Probe550WestAvenueStanford,CT06902TradeName:LIFECODESHLA‐AeRESTypingKitforusewithLuminexLIFECODESHLA‐BeRESTypingKitforusewithLuminexLIFECODESHLA‐DRB3,4,5TypingKitforusewithLuminexLIFECODESHLA‐DRB1eRESTypingKitforusewithLuminexClearedDate:02‐DEC‐2011BK120063‐0Gen‐Probe550WestAvenueStanford,CT06902TradeName:LIFECODESHLA‐CeRESTypingKitforusewithLuminexClearedDate:21‐NOV‐2012BK040019‐0Gen‐ProbeGTIDiagnostics20925CrossroadsCircleWaukesha,WI53186TradeName:AntibodyMonitoringSystemClassIandClassII(AMS1andAMS1+2)ClearedDate:06‐JUL‐2004ClearedUnderGTI,INCBK040034‐0Gen‐ProbeGTIDiagnostics20925CrossroadsCircleWaukesha,WI53186TradeName:LifecodesLifeScreen:ALuminex100ScreeningAssayfortheDetectionofIgGAntibodiestoHLAClassIandClassIIMoleculesofHumanOriginClearedDate:16‐JUL‐2004ClearedUnderGTI,INCBK040035‐0Gen‐ProbeGTIDiagnostics20925CrossroadsCircleWaukesha,WI53186TradeName:LifecodesIDClassI:ALuminex100screeningassayforthequalitativedetectionofIgGpanelreactiveantibodies(PRA)toHLAClassImoleculesLifecodesIDClassII:ALuminex100screeningassayforthequalitativedetectionofIgGpanelreactiveantibodies(PRA)toHLAClassIImoleculesClearedDate:16‐JUL‐2004ClearedUnderGTI,INCBK050040‐0Gen‐ProbeGTIDiagnostics20925CrossroadsCircleWaukesha,WI53186TradeName:ThromboType(HPA1‐6,15)andThromboType1(HPA1)ClearedDate:20‐JAN‐2006ClearedUnderGTI,INCBK050054‐0Gen‐ProbeGTIDiagnostics20925CrossroadsCircleWaukesha,WI53186TradeName:GranType(TM)ClearedDate:02‐MAR‐2006ClearedUnderGTI,INCBK060038‐0Gen‐ProbeGTIDiagnostics20925CrossroadsCircleWaukesha,WI53186TradeName:MICROAMSClearedDate:28‐JUL‐2006ClearedUnderGTI,INCBK070034‐0Gen‐ProbeGTIDiagnostics20925CrossroadsCircleWaukesha,WI53186TradeName:HLAEZTypeClearedDate:10‐JUL‐2008ClearedUnderGTI,INCBK070045‐0Gen‐ProbeGTIDiagnostics20925CrossroadsCircleWaukesha,WI53186TradeName:DonorScreenHLAClassIandClassIIClearedDate:30‐JUL‐2008ClearedUnderGTI,INCBK110011‐0Gen‐ProbeGTIDiagnostics20925CrossroadsCircleWaukesha,WI53186TradeName:LifecodesClassIIIDv2ClearedDate:04‐JUN‐2012BK850003‐0GenesisBPS,LLC65CommerceWayHackensack,NJ07601TradeName:CryosanPediatricPackClearedDate:05‐APR‐1985ClearedUnderCryosanInc.
BK950018‐0GenesisBPS,LLC65CommerceWayHackensack,NJ07601TradeName:TOTALCONTAINMENTDEVICE(TCD)ClearedDate:14‐NOV‐1995ClearedUnderDENCO,INC.
BK140187‐0GenesisBPS,LLC465StateRoute17Ramsey,NJ07446TradeName:BladeArmModuleGenesisRapidWeldSTWWeldBladeModuleReplacementKitsClearedDate:06‐MAR‐2015BK880025‐0GeneticDesignInc.
7019AlbertPickRd.
;SuiteHGreensboro,NC27409TradeName:HLA‐DRTypingTraysClearedDate:30‐DEC‐1988BK870006‐0GeneticSystemsCorporation3005FirstAvenueSeattle,WA98121TradeName:HLA‐B27AntigenTypingKitClearedDate:20‐JUL‐1987BK900011‐0GeneticSystemsCorporation3005FirstAvenueSeattle,WA98121TradeName:GeneticSystemsBloodVirusSoftwareClearedDate:15‐MAR‐1991BK930031‐0GeneticSystemsCorporation3005FirstAvenueSeattle,WA98121TradeName:ExpressoCartridgeSoftwareforBloodVirusApplicationsClearedDate:24‐FEB‐1994BK860022‐0GeneticTestingInstitute1701W.
WisconsinAvenue,Suite429Milwaukee,WI53233TradeName:GTI‐60HLATypingTraysGTI‐72HLATypingTraysGTI‐96HLATypingTraysClearedDate:24‐FEB‐1987BK910013‐0GeneticTestingInstitute1701W.
WisconsinAvenue,Suite429Milwaukee,WI53233TradeName:GTIPepAntibodyEnhancementSolutionClearedDate:23‐JUN‐1992BK930014‐0GeneticTestingInstitute1701W.
WisconsinAvenue,Suite429Milwaukee,WI53233TradeName:GTIReducedWashElutionKitClearedDate:28‐OCT‐1993BK930032‐0GeneticTestingInstitute1701W.
WisconsinAvenue,Suite429Milwaukee,WI53233TradeName:GTIACEAntigenCaptureELISAforDetectionofIgGAntibodiestoPlateletSpecificAntibodiesClearedDate:20‐JUN‐1994BK950004‐0GeneticTestingInstitute1701W.
WisconsinAvenue,Suite429Milwaukee,WI53233TradeName:GTI‐PAK2PlateletAntibodyScreeningKitClearedDate:15‐MAY‐1995BK950005‐0GeneticTestingInstitute1701W.
WisconsinAvenue,Suite429Milwaukee,WI53233TradeName:GTI‐HLA1,ClassIAntibodyScreeningKitClearedDate:19‐MAY‐1995BK970006‐0GeneticTestingInstitute1701W.
WisconsinAvenue,Suite429Milwaukee,WI53233TradeName:GTI‐HAT,Heparin‐AssociatedAntibodyScreeningKitClearedDate:14‐APR‐1997BK980005‐0GeneticTestingInstitute150N.
PatrickBlvd.
Brookfield,WI53045TradeName:GTIPATHPA‐1(PI)GenotypingKitClearedDate:23‐APR‐1999BK000015‐0GeneticTestingInstitute150N.
PatrickBlvd.
Brookfield,WI53045TradeName:QuickIDSolidPhaseELISAfordetectionofPanelReactiveHLAClassIIgGAntibodies(PRA)ClearedDate:17‐OCT‐2000BK000031‐0GeneticTestingInstitute150N.
PatrickBlvd.
Brookfield,WI53045TradeName:GTI‐MACE(ModifiedCaptureElisa)ClearedDate:29‐JAN‐2001BK990043‐0GeneticTestingInstitute150N.
PatrickBlvd.
Brookfield,WI53045TradeName:B‐ScreenSolidPhaseELISAAssayforDetectionofIgGAntibodiestoHLAClassIIAntigensClearedDate:02‐OCT‐2000BK010010‐0GeneticTestingInstitute150N.
PatrickBlvd.
Brookfield,WI53045TradeName:Quik‐IDClassIIClearedDate:01‐OCT‐2001BK960059‐0GeneticTestingInstitute,Inc.
(GTI)20925CrossroadsCircleSutie200Waukesha,WI53186TradeName:PAKAUTOPlateletAntibodyScreeningKitClearedDate:22‐OCT‐1998ClearedUnderGeneticTestingInstituteBK090002‐0GeneticTestingInstitute,Inc.
(GTI)20925CrossroadsCircleSutie200Waukesha,WI53186TradeName:LifecodesLifeScreenDeluxeClearedDate:17‐APR‐2009BK150354‐0GenteelLLC4011LivingstonStMidland,TX79709TradeName:GenteelLancingDevice(Genteel)ClearedDate:18‐DEC‐2015BK940057‐0George‐KingBio‐Medical,Inc.
11771W112thSt,OverlandPark,KS66210TradeName:B‐Fact,BorderlineFactorAssayControlClearedDate:14‐NOV‐1994BK940058‐0George‐KingBio‐Medical,Inc.
11771W112thSt,OverlandPark,KS66210TradeName:A‐Fact,AbnormalFactorAssayControlClearedDate:14‐NOV‐1994BK940059‐0George‐KingBio‐Medical,Inc.
11771W112thSt,OverlandPark,KS66210TradeName:PositiveLupusAnticoagulantPlasmaClearedDate:14‐NOV‐1994BK940060‐0George‐KingBio‐Medical,Inc.
11771W112thSt,OverlandPark,KS66210TradeName:ProteinCDeficientPlasmaClearedDate:14‐NOV‐1994BK050026‐0GreinerBioOneNorthAmerica,Inc.
4238CapitalDriveMonroe,NC28110TradeName:GreinerVacuetteNoAdditiveTubesClearedDate:07‐JUL‐2005BK050028‐0GreinerBioOneNorthAmerica,Inc.
4238CapitalDriveMonroe,NC28110TradeName:GreinerVacuetteClotActivatorTubeClearedDate:07‐JUL‐2005BK030001‐0GreinerBio‐OneGmbH4238CapitalDriveMonroe,NC28112TradeName:GreinerVacuetteEDTAK3TubeClearedDate:26‐FEB‐2003BK030032‐0GreinerBio‐OneGmbH4238CapitalDriveMonroe,NC28112TradeName:VacuetteEDTAK2TubeClearedDate:18‐JUL‐2003BK040066‐0GreinerVacuetteNorthAmerica,Inc.
4238CapitalDrMonroe,NC28110TradeName:GreinerVACUETTENoAdditiveEvacuatedBloodCollectionTubesandSerumClotActivatorBloodCollectionTubesClearedDate:10‐SEP‐2004ClearedUndersiennapartnersBK140150‐0GrifolsDiagnosticSolutionsInc.
4560HortonStreet,M/SN‐200Emeryville,CA94608‐2916TradeName:ProcleixXpressSystemClearedDate:27‐AUG‐2014BK170162‐0GrifolsDiagnosticSolutionsInc.
4560HortonStreet,M/SN‐200Emeryville,CA94608‐2916TradeName:ProcleixXpressSystem(Softwarev3.
0)ClearedDate:18‐JAN‐2018BK200449‐0HaeleonMedical,Inc.
1090LawrenceDrNewburyPark,CA91320TradeName:HealeonDuetClearedDate:06‐AUG‐2020BK840002‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:AlphaPlasmaPoolingBottleIIClearedDate:13‐JUL‐1984BK840007‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:AlphaPlasmaPoolingBottleClearedDate:21‐SEP‐1984BK840014‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsV50SurgeProcedureClearedDate:06‐JUL‐1984BK840021‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsPCSPlasmaCollectionSystemClearedDate:03‐JAN‐1985BK840022‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:Haemonetics115CellWasherClearedDate:24‐OCT‐1984BK840025‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:Haemonetics16ProgrammedPumpClearedDate:14‐NOV‐1984BK860013‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:603‐EXExtendedStoragePlateletpheresisSetClearedDate:06‐NOV‐1987BK870026‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsUltralitePlasmaCollectionSystemClearedDate:17‐MAR‐1988BK890007‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:Haemonetics705TimeSaverPlateletPackClearedDate:13‐AUG‐1990BK900019‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:AlphaPlasmaPoolingBottleII(SignificantRev.
)ClearedDate:14‐AUG‐1990BK900022‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:PlasmaPoolingBottleII(SignificantRevision)ClearedDate:11‐OCT‐1990BK900027‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:790ESPCollectionSetClearedDate:19‐APR‐1991BK910009‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:AlphaPlasmaPoolingBottleII(SignificantRev.
)ClearedDate:08‐SEP‐1991BK920012‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:705FTSPP/790FClearedDate:16‐SEP‐1992BK920039‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:PlasmaCollectionSystemPCS2ClearedDate:02‐SEP‐1993BK930007‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:790ExtendedStoragePlateletCollectionSetClearedDate:16‐NOV‐1993BK930008‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:791AFreshFrozenPlasmaCollectionSet(LathamBowl)ClearedDate:16‐NOV‐1993BK930009‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:791FreshFrozenPlasmaCollectionSet(BlowMoldedBowl)ClearedDate:16‐NOV‐1993BK930013‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:MCSPlus&Disp.
Sets,ListNo.
890,790,791A,791ClearedDate:12‐JAN‐1994BK940064‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:RedCellandPlasmaApheresisSet/FORUSEWITHMCPPLUSClearedDate:23‐OCT‐1995BK950001‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsRBCApheresisSetforMCS+(NO.
831)ClearedDate:22‐APR‐1996BK950006‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:List#890FExtendedStoragePltCollectionSetClearedDate:09‐JUN‐1995BK950007‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:ESPWhiteCellFilter(No.
790F)ClearedDate:28‐JUN‐1995BK950033‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsPCS2ClearedDate:16‐APR‐1996BK950034‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:DoubleProductCollection(SDP‐3)ClearedDate:15‐FEB‐1996BK950063‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:RedBloodCellandPlasmaCollectionSetfortheMCSPlus#823ClearedDate:22‐JUL‐1996BK960006‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:DoubleUnitRedBloodCellAphersisSetMCS#833ClearedDate:15‐OCT‐1996BK960022‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:MCS+DoubleUnitRBCApheresisSet‐Dry(LN832)ClearedDate:16‐APR‐1997BK960023‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:MCS+RedCell&PlasmaApheresisSet‐Dry(LN822)ClearedDate:16‐APR‐1997BK960095‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:MCS+ApheresisSystem(LN8150)ClearedDate:11‐APR‐1997BK970029‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:AlphaPlasmaPoolingBottleII(60‐2227S)ClearedDate:07‐JAN‐1998ClearedUnderAlphaTherapeuticCorporationBK970034‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:LN994CFClearedDate:15‐SEP‐1998BK970041‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsCorp.
ExtendedStoragePlatelet&PlasmaApheresisSetwithSalineCompensation&PallLRF‐XL(LN994C)ClearedDate:16‐NOV‐1998BK980040‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:CitroflexPlalsticizedPVCExtendedStoragePlateletBagClearedDate:07‐JAN‐1999BK000002‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:Model215AutomatedGlycerolizationandDeglycerolizationSystemClearedDate:04‐MAY‐2001BK990033‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:MCS+LN8150ClearedDate:20‐JAN‐2000BK990044‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsLN832FTwoUnitRedCellsDisposableSetwithLeukocytereductionFilterClearedDate:27‐OCT‐2000BK000048‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsLN832FClearedDate:09‐APR‐2001BK010035‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:MCS+MobileCollectionSystemClearedDate:20‐DEC‐2002BK020001‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:PlasmaPoolingBottleIIClearedDate:29‐MAR‐2002BK030031‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsModel215AutomatedGlycerolyzation/DeglycerolyzationandCellWashingSystemClearedDate:10‐SEP‐2003BK030062‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsModel215AutomatedGlycerolization/deglycerolizationSystemClearedDate:10‐DEC‐2003BK030084‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsLN994CF‐CPP‐BAExtendedStoragePlateletandPlasmaApheresisSetClearedDate:09‐JAN‐2004BK040001‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:Haemonetics4mLSamplingSystemClearedDate:27‐FEB‐2004BK040020‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsLN994CF‐BAExtendedStoragePlateletandPlasmaApheresisSetwithLeukocyteReductionFilter,and4mLSamplingSystem.
ClearedDate:29‐MAR‐2004BK040025‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:PCS2PlasmaCollectionSystemClearedDate:02‐JUN‐2004BK040041‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsMCS+8150ApheresisSystemClearedDate:12‐JUL‐2004BK040077‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsModel215AutomatedGlycerolization/DeglycerolizationSystemClearedDate:21‐DEC‐2004BK050006‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:ACP215Glycerolization/DeglycerolizationSystemClearedDate:14‐APR‐2005BK050047‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:MCS+9000,SDPrevisionEsoftware,994CF‐CPPseriesdisposablesetsClearedDate:21‐NOV‐2005BK050048‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsMCS+8150ApheresisSystemClearedDate:27‐SEP‐2005BK060008‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsACP215Glycerolization/DeglycerolizationSystemClearedDate:23‐MAY‐2006BK060023‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsMCS+8150ApheresisSystemClearedDate:23‐MAY‐2006BK060033‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsPCS2PlasmaCollectionSystem,Wireless(W)CapableModification‐ClearedDate:27‐MAR‐2008BK060057‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:CymbalAutomatedBloodCollectionSystemClearedDate:28‐FEB‐2007BK070019‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsPCS2PlasmaCollectionSystemClearedDate:23‐MAY‐2007BK080025‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:CymbalAutomatedBloodCollectionSystemClearedDate:15‐AUG‐2008BK090041‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:SymphonySystemClearedDate:28‐SEP‐2009BK090083‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:CymbalAutomatedBloodCollectionSystemClearedDate:27‐JAN‐2010BK110015‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:Nextgen‐1.
0.
0ClearedDate:13‐JUN‐2011BK120065‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:PCS2PlasmaCollectionSystemClearedDate:26‐NOV‐2012BK120083‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:MCS+8150System‐WirelessClearedDate:20‐MAR‐2013BK120084‐0HaemoneticsCorporation4925RobertJMathewsParkwaySuite100ElDoradoHills,CA95762TradeName:PhlebotomySystemClearedDate:30‐APR‐2013BK130056‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsPCS2PlasmaCollectionSystemClearedDate:29‐AUG‐2014BK130081‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:CymbalAutomatedBloodCollectionSystemClearedDate:23‐JAN‐2014BK130082‐0HaemoneticsCorporation4925RobertJMathewsParkwaySuite100ElDoradoHills,CA95762TradeName:NextGenClearedDate:08‐AUG‐2014BK140108‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:MCS+8150ClearedDate:26‐AUG‐2014BK140199‐0HaemoneticsCorporation4925RobertJMathewsParkwaySuite100ElDoradoHills,CA95762TradeName:Surround5.
1ClearedDate:05‐FEB‐2015BK150287‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsMCS+8150ApheresisSystemClearedDate:28‐JUL‐2015BK150292‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:HaemoneticsPCS2PlasmaCollectionSystemClearedDate:28‐JUL‐2015BK150360‐0HaemoneticsCorporation4925RobertJMathewsParkwaySuite100ElDoradoHills,CA95762TradeName:SafeTraceTx3.
12.
0DeviceClearedDate:11‐MAR‐2016BK160019‐0HaemoneticsCorporation4925RobertJMathewsParkwaySuite100ElDoradoHills,CA95762TradeName:ElDoradoDonor4NextGenerationDonorManagementSolution1.
0.
0ClearedDate:17‐MAY‐2016BK160052‐0HaemoneticsCorporation4925RobertJMathewsParkwaySuite100ElDoradoHills,CA95762TradeName:InstaMatch1.
0.
0ClearedDate:25‐AUG‐2016BK170045‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:PCS300PlasmaCollectionSystemClearedDate:25‐JUL‐2017BK180185‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:PCS300PlasmaCollectionSystemClearedDate:27‐MAR‐2018BK180209‐0HaemoneticsCorporation400WoodRoadBraintree,MA02184‐9114TradeName:SafeTraceTx‐4.
0.
0SafeTraceTxClearedDate:07‐AUG‐2018BK200498‐0HaemoneticsCorporation125SummerStBoston,MA02110TradeName:NexSysPCSPlasmaCollectionSystemwithPersonaTechnologyClearedDate:02‐OCT‐2020BK080001‐0HaemoneticsCorporationSoftwareSolutions1630IndustrialParkStreetCovina,CA91722‐9144TradeName:PCS2PlasmaCollectionSystem_RevisionKsoftwareClearedDate:28‐MAY‐2008ClearedUnderHaemoneticsCorporationBK080038‐0HaemoneticsCorporationSoftwareSolutions1630IndustrialParkStreetCovina,CA91722‐9144TradeName:MCS+9000SystemClearedDate:04‐SEP‐2008ClearedUnderHaemoneticsCorporationBK090004‐0HaemoneticsCorporationSoftwareSolutions1630IndustrialParkStreetCovina,CA91722‐9144TradeName:MCS+8150System‐WirelessClearedDate:20‐FEB‐2009ClearedUnderHaemoneticsCorporationBK140133‐0HaemoneticsCorporationSoftwareSolutions4925RobertJ.
MatthewsParkwaySuite100ElDoradoHills,CA95762TradeName:BloodTrack‐4.
7.
0ClearedDate:29‐AUG‐2014BK140166‐0HaemoneticsCorporationSoftwareSolutions4925RobertJ.
MatthewsParkwaySuite100ElDoradoHills,CA95762TradeName:CrossDonationCheckSystem(CDCS)‐1.
0.
0ClearedDate:10‐OCT‐2014BK140183‐0HaemoneticsCorporationSoftwareSolutions4925RobertJ.
MatthewsParkwaySuite100ElDoradoHills,CA95762TradeName:DonorDoc3.
0.
0ClearedDate:10‐DEC‐2014BK150308‐0HaemoneticsCorporationSoftwareSolutions4925RobertJ.
MatthewsParkwaySuite100ElDoradoHills,CA95762TradeName:ElDoradoDonor‐3.
0.
0ClearedDate:20‐NOV‐2015BK150330‐0HaemoneticsCorporationSoftwareSolutions4925RobertJ.
MatthewsParkwaySuite100ElDoradoHills,CA95762TradeName:NextGen3.
0.
0ClearedDate:03‐MAR‐2016BK820014‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PlasmaPoolingBagsClearedDate:08‐FEB‐1983ClearedUnderCutterBiologicalBK840010‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:CLXTransferBagClearedDate:15‐AUG‐1984ClearedUnderCutterBiologicalBK850026‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:NeocelSystemClearedDate:22‐MAY‐1986ClearedUnderMiles,Inc.
BK860001‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:LeukotrapSystemClearedDate:05‐AUG‐1986ClearedUnderCutterBiologicalBK860006‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:CutterPPPHarnessClearedDate:17‐SEP‐1986ClearedUnderMiles,Inc.
BK860028‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:ComponentAliquotSystemClearedDate:07‐DEC‐1987ClearedUnderMiles,Inc.
BK860040‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:BloodCollectionUnitw/oAnticoagulantClearedDate:24‐JUN‐1987ClearedUnderCutterBiologicalBK900034‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PhlebotomistProtectionDeviceClearedDate:27‐JAN‐1992ClearedUnderMiles,Inc.
BK920027‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PlasmaPoolingBagClearedDate:13‐APR‐1993ClearedUnderMiles,Inc.
BK930001‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PlasmaSampleVialClearedDate:20‐SEP‐1993ClearedUnderMiles,Inc.
BK970040‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:MedsepPlasmaBagClearedDate:23‐JAN‐1998ClearedUnderMEDSEPCorp.
BK000032‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:ModifiedPlasmaBagClearedDate:27‐SEP‐2000ClearedUnderMEDSEPCorp.
BK020014‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PallBacterialDetectionSystem(BDS)ClearedDate:22‐OCT‐2002ClearedUnderMedsepCorporationBK030082‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PalleBDSClearedDate:04‐FEB‐2004ClearedUnderMedsepCorporationBK050015‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:LeukotrapSCRCFiltrationSystemClearedDate:14‐APR‐2005ClearedUnderMEDSEPCorp.
BK050034‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PallAcrodosePLSystem,PlateletPoolandStoreSetwitheBDSPallPlateletPoolandStoreSetwithPalleBDSClearedDate:28‐SEP‐2005ClearedUnderMedsepCorporationBK050074‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PallAcrodosePLSystemClearedDate:26‐JAN‐2006ClearedUnderMedsepCorporationBK050075‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PalleBDSClearedDate:20‐DEC‐2005ClearedUnderMedsepCorporationBK060040‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PallAcrodosePLSystem,PlateletPoolandStoreSetwithin‐lineLeukocyteReductionFilterClearedDate:12‐APR‐2007ClearedUnderMedsepCorporationBK060044‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PallAcrodosePLSystem,PlateletPoolandStoreSetwitheBDSClearedDate:01‐SEP‐2006ClearedUnderMedsepCorporationBK060045‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PallAcrodosePLSystem,PlateletPoolandStoreSetClearedDate:01‐SEP‐2006ClearedUnderMedsepCorporationBK060047‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PalleBDSClearedDate:04‐APR‐2007ClearedUnderMedsepCorporationBK070004‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PalleBDSClearedDate:26‐JUN‐2007ClearedUnderMedsepCorporationBK070056‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PallAcrodosePLusSystemPlateletPoolandStoreSetwithin‐lineLeukocyteReductionFilterandeBDSClearedDate:27‐SEP‐2007ClearedUnderMedsepCorporationBK070057‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PallAcrodosePLusSystemPlateletPoolandStoreSetwithin‐lineLeukocyteReductionFilterClearedDate:27‐SEP‐2007ClearedUnderMedsepCorporationBK070063‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PalleBDSClearedDate:26‐JAN‐2008ClearedUnderMedsepCorporationBK080003‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PallAcrodosePLusSystem,PlateletPoolandStoreSetwithin‐LineLeukocyteReductionFilterClearedDate:18‐APR‐2008ClearedUnderMEDSEPCorporationBK090007‐0HaemoneticsManufacturingInc.
400WoodRoadBraintree,MA02184TradeName:PallAcrodosePLSystemClearedDate:25‐FEB‐2009ClearedUnderMedsepCorporationBK160027‐0HaemoneticsManufacturingInc.
1630IndustrialParkStreetCovina,CA91722TradeName:AcrodosePLSystemClearedDate:16‐MAY‐2016BK000037‐0HarvestTechnologies40GrissomRoadPlymouth,MA02360TradeName:HarvestPRPSeparationSystemClearedDate:05‐FEB‐2001BK100059‐0HarvestTechnologies40GrissomRoadPlymouth,MA02360TradeName:HarvestPRPSeparationSystemClearedDate:18‐NOV‐2010BK120038‐0HarvestTechnologies40GrissomRoadPlymouth,MA02360TradeName:HarvestPRPSeparationSystemwithACDA(30mL)ClearedDate:28‐SEP‐2012BK130068‐0HarvestTechnologies40GrissomRoadPlymouth,MA02360TradeName:SmartPrep2SystemClearedDate:24‐MAR‐2014BK200526‐0HeadspringHealthcare,Inc10415MoradoCircleAustin,TX78759TradeName:NDDRandCDCSClearedDate:18‐NOV‐2020BK170136‐0HealeonMedical,Inc.
1111RanchoConejoBlvd#204NewburyPark,CA91320TradeName:HealeonPRPPlateletPreparationSystemClearedDate:20‐NOV‐2018BK050001‐0HealthcareManagementSystems,Inc.
3102WestEndAvenue,Suite400Nashville,TN37203TradeName:MonitorBloodAdministrationModule‐Release24.
0ClearedDate:28‐SEP‐2005BK090025‐0HealthcareManagementSystems,Inc.
3102WestEndAvenue,Suite400Nashville,TN37203TradeName:HMSBloodAdministrationModule,Release8.
0ClearedDate:04‐MAR‐2010BK030049‐0Healthcare‐ID,Inc.
1635BarclayBlvd.
BuffaloGrove,IL60089TradeName:Donor‐ID‐version2.
5ClearedDate:31‐OCT‐2003ClearedUnderHealthcare‐IDBK060058‐0Healthcare‐ID,Inc.
1635BarclayBlvd.
BuffaloGrove,IL60089TradeName:Donor‐ID‐3.
0ClearedDate:08‐FEB‐2007ClearedUnderHealthcare‐IDBK080044‐0Healthcare‐ID,Inc.
1635BarclayBlvd.
BuffaloGrove,IL60089TradeName:Donor‐IDWeb‐3.
1.
4ClearedDate:10‐JUN‐2009ClearedUnderHealthcare‐IDBK120030‐0Healthcare‐ID,Inc.
1635BarclayBlvd.
BuffaloGrove,IL60089TradeName:Donor‐IDWeb(TM)3.
2ClearedDate:25‐JUN‐2012ClearedUnderHealthcare‐IDBK140149‐0Healthcare‐ID,Inc.
1635BarclayBlvd.
BuffaloGrove,IL60089TradeName:Donor‐IDTMversion3.
2.
6ClearedDate:23‐JAN‐2015BK150279‐0Healthcare‐ID,Inc.
1635BarclayBlvd.
BuffaloGrove,IL60089TradeName:Donor‐ID3.
2integratedwithiCASIAppiOSClearedDate:12‐NOV‐2015BK160039‐0Healthcare‐ID,Inc.
1635BarclayBlvd.
BuffaloGrove,IL60089TradeName:Donor‐ID3.
2integratedwithiCASIAppAndroidClearedDate:29‐JUL‐2016BK170141‐0HelmerInc.
14400BergenBlvdNoblesville,IN46060TradeName:UltraCWUltraCWIIAutomaticCellWashingSystemClearedDate:22‐JAN‐2018BK820013‐0HelmerLabs.
,Inc.
5415DistributionDriveFortWayne,IN46825TradeName:PlateletAgitatorClearedDate:29‐OCT‐1982BK820022‐0HelmerLabs.
,Inc.
5415DistributionDriveFortWayne,IN46825TradeName:HelmerIncubator‐AgitatorClearedDate:03‐JAN‐1983BK840027‐0HelmerLabs.
,Inc.
5415DistributionDriveFortWayne,IN46825TradeName:HelmerPlateletAgitatorPF108HelmerPlateletAgitatorPF54ClearedDate:16‐APR‐1985BK850014‐0HelmerLabs.
,Inc.
5415DistributionDriveFortWayne,IN46825TradeName:PLATELETFLATBEDAGITATORMODELPF456ClearedDate:30‐AUG‐1985BK850015‐0HelmerLabs.
,Inc.
5415DistributionDriveFortWayne,IN46825TradeName:HelmerIncubatorModelsPC1000HelmerIncubatorModelsPC2000HelmerIncubatorModelsPC3000ClearedDate:20‐SEP‐1985BK850018‐0HelmerLabs.
,Inc.
5415DistributionDriveFortWayne,IN46825TradeName:TubeStripperClearedDate:21‐OCT‐1985BK940051‐0HelmerLabs.
,Inc.
5415DistributionDriveFortWayne,IN46825TradeName:HelmerWaterPlasmaThawerClearedDate:03‐MAR‐1995BK020029‐0HelmerLabs.
,Inc.
15425HerrimanBoulevardNoblesville,IN46060TradeName:UltraCW(withSoftwareversion3.
13)ClearedDate:04‐OCT‐2002BK890028‐0HemagenDiagnostics,Inc.
9033RedBranchRoadColumbia,MD21045TradeName:OlypmusPKCMVSystemClearedDate:11‐DEC‐1989BK940035‐0HemagenDiagnostics,Inc.
9033RedBranchRoadColumbia,MD21045TradeName:OlympusPKTMCMVSystem&SystemControlsClearedDate:15‐JUL‐1996BK150300‐0HemasoftSoftwareSLAntonioLopez249,43AMadrid,SPAIN28041TradeName:e‐DelphynBloodmanagementSoftwareversion7.
1.
0.
0ClearedDate:24‐OCT‐2015BK200513‐0HemasoftSoftwareSLCalleAntonioLopez,2494,MadridSPAIN28041TradeName:e‐DelphynLISDonor‐11.
0.
0.
1ClearedDate:09‐NOV‐2020BK200515‐0HemasoftSoftwareSLCalleAntonioLopez,2494,MadridSPAIN28041TradeName:e‐DelphynDonor‐11.
0.
0.
1ClearedDate:05‐NOV‐2020BK950008‐0Hemasure,Inc.
140LockeDriveMarlborough,MA01752TradeName:LeukoNetPreStorageLeukodepletionFilterationSystemClearedDate:28‐JUN‐1995BK980014‐0Hemasure,Inc.
140LockeDriveMarlborough,MA01752TradeName:HemaSurer|LSPre‐StorageLeukoreductionFiltrationSystemforRedBloodCellsHemaSurer|LSPre‐StorageLeukoreductionFiltrationSystemwithspikeforRedBloodCellsClearedDate:27‐MAY‐1999BK070024‐0HemerusMedical,LLC5000TownshipParkwaySaintPaul,MN55110TradeName:LEUKOSEPHRC‐600‐CLeukocyteReductionFiltrationSystemforRedBloodCellsClearedDate:23‐AUG‐2007BK080031‐0HemerusMedical,LLC5000TownshipParkwaySaintPaul,MN55110TradeName:HEMERUSLEUKOSEPHRC‐600‐CLeukocyteReductionFiltrationSystemforRedBloodCellsClearedDate:11‐SEP‐2008BK120022‐0Hemobioscience801CapitolaDrive,Suite9ResearchTriangleParkDurham,NC27713TradeName:C3ControlCellsClearedDate:24‐OCT‐2012BK140161‐0Hemobioscience801CapitolaDrive,Suite9ResearchTriangleParkDurham,NC27713TradeName:HemoQCClearedDate:08‐SEP‐2014BK160079‐0Hemobioscience633DavisDriveSuite100Morrisville,NC27560TradeName:MQCClearedDate:27‐FEB‐2017BK160081‐0Hemobioscience633DavisDriveSuite100Morrisville,NC27560TradeName:MQC‐CATClearedDate:30‐MAR‐2017BK060020‐0HemoCueAB40EmpireDriveLakeForest,CA92630TradeName:HemoCueHb301SystemClearedDate:14‐APR‐2006BK060048‐0HemoCueABKuvettgatan1Angelholm,SWEDENSE‐26271TradeName:HemoCueHb301SystemClearedDate:05‐OCT‐2006BK000043‐0HemoCue,Incorporated9229CranfordDrivePotomac,MD20854TradeName:HemoCueLowHemoglobinAnalyzingSystemClearedDate:09‐APR‐2001BK030020‐0HemoCue,Incorporated9229CranfordDrivePotomac,MD20854TradeName:DonorHemoglobinCheckerSystemClearedDate:17‐APR‐2003BK030067‐0HemoCue,Incorporated9229CranfordDrivePotomac,MD20854TradeName:HemoCueDonorHbCheckerControlClearedDate:19‐DEC‐2003BK040031‐0Hemosystem,S.
A.
45,CoursGouffe13006Marseille,FRANCETradeName:ScansytembacterialdetectiondeviceClearedDate:23‐SEP‐2004BK900024‐0HeraeusInc.
111ACorporateBlvd,S.
Plainfield,NJ07080TradeName:Cryofuge6000ClearedDate:05‐NOV‐1992BK200519‐0HoldingTechnologies600‐ARoyalCommerceRdSuiteARoyalPalmBeach,FL33411TradeName:MaximusBloodPRPKitClearedDate:19‐NOV‐2020BK900015‐0I.
B.
G.
SystemsInc.
P.
O.
Box5306Laytonsville,MD20882TradeName:InvernessBloodGroupingSystemClearedDate:20‐SEP‐1990BK920019‐0I.
B.
G.
SystemsInc.
P.
O.
Box5306Laytonsville,MD20882TradeName:InvernessAutomatedAntibodyScreeningSystemClearedDate:26‐MAR‐1993BK930025‐0ICUMEDICALINC142TECHNOLOGYDRIVEIRVINE,CA92718TradeName:KelseaClampNeedleCover&GuideClearedDate:28‐OCT‐1993BK110064‐0ITSynergistics,LLC115TreeStreetFlowood,MS39232TradeName:DoVacElite1.
0ClearedDate:06‐SEP‐2012BK140091‐0ITSynergistics,LLC115TreeStreetFlowood,MS39232TradeName:DVacElitev2.
0ClearedDate:09‐APR‐2014BK030087‐0ITLCorporationPty,Ltd41‐45TennantStreetCanberraACT2609,AUSTRALIATradeName:ITLSampLokSamplingKitClearedDate:18‐FEB‐2004BK170102‐0ITLCorporationPty,Ltd41‐45TennantStreetCanberraACT2609,AUSTRALIATradeName:SamplokSegmentSamplerClearedDate:28‐NOV‐2017BK980008‐0ITLCorporation,LTD.
22MolongloMallFyshwick,CanberraAUSTRALIA2609TradeName:BloodpackNeedleProtector(BNP)ClearedDate:07‐APR‐1998BK820010‐0IdasAmericaLtd.
LockviewPlazaLockport,NY14094TradeName:AnimecClearedDate:14‐SEP‐1982BK130046‐0ImmucorGTIDiagnostics,Inc.
20925CrossroadsCircleWaukesha,WI53186TradeName:LIFECODES(R)LifeScreenDeluxe(LMX)ClearedDate:23‐SEP‐2013BK140163‐0ImmucorGTIDiagnostics,Inc.
20925CrossroadsCircleWaukesha,WI53186TradeName:PakPlusClearedDate:27‐APR‐2015BK160035‐0ImmucorGTIDiagnostics,Inc.
20925CrossroadsCircleWaukesha,WI53186TradeName:LIFECODESLifeScreenDeluxe(LMX)ClearedDate:21‐APR‐2016BK180181‐0ImmucorGTIDiagnostics,Inc.
20925CrossroadsCircleWaukesha,WI53186TradeName:DonorScreen‐HLAClassIandClassIIClearedDate:14‐JUN‐2018BK190439‐0ImmucorGTIDiagnostics,Inc.
20925CrossroadsCircleWaukesha,WI53186TradeName:MATCHIT!
DNAClearedDate:21‐JAN‐2020BK130075‐0ImmucorTransplantDiagnostics,Inc.
550WestAvenueStamford,CT06902‐6352TradeName:LIFECODESHLA‐ASSOTypingKitforusewithLuminexLIFECODESHLA‐AeRESSSOTypingKitforusewithLuminexLIFECODESHLA‐BSSOTypingKitforusewithLuminexLIFECODESHLA‐BeRESSSOTypingKitforusewithLuminexLIFECODESHLA‐CeRESSSOTypingKitforusewithLuminexLIFECODESHLA‐DQBSSOTypingKitforusewithLuminexLIFECODESHLA‐DRB1SSOTypingKitforusewithLuminexLIFECODESHLA‐DRB1eRESSSOTypingKitforusewithLuminexClearedDate:24‐DEC‐2013BK150302‐0ImmucorTransplantDiagnostics,Inc.
550WestAvenueStamford,CT06902‐6352TradeName:LIFECODESHLA‐DPA1/B1SSOTypingKitLIFECODESHLA‐DQAI/B1SSOTypingKitClearedDate:11‐MAY‐2016BK150343‐0ImmucorTransplantDiagnostics,Inc.
550WestAvenueStamford,CT06902‐6352TradeName:LIFECODESMATCHIT!
DNASoftwarev1.
2ClearedDate:11‐MAY‐2016BK820019‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:CheckcellClearedDate:15‐DEC‐1982BK830004‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:22%BovineAlbuminClearedDate:17‐MAR‐1983BK830005‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:30%BovineAlbuminClearedDate:17‐MAR‐1983BK830007‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:LowIonicStrengthSolution(LISS)ClearedDate:11‐MAY‐1983BK830013‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Rh‐HrControlClearedDate:19‐JUL‐1983BK830021‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Anti‐NLectinClearedDate:07‐NOV‐1983BK830022‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:ImmuAddClearedDate:07‐NOV‐1983BK830018‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Anti‐A1LectinClearedDate:07‐NOV‐1983BK840024‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:corQcTestSystemClearedDate:08‐NOV‐1984BK860017‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:CapturePSolidPhaseSystemClearedDate:06‐OCT‐1986BK880010‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Capture‐R(IandII)ClearedDate:03‐JUN‐1988BK880011‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Capture‐R(Pooled)ClearedDate:03‐JUN‐1988BK880014‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:ModifiedCapture‐PClearedDate:08‐DEC‐1988BK880015‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Capture‐PPlateletsWash&StorageSolutionClearedDate:08‐DEC‐1988BK880022‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:CapturePReadyScreenSolidPhaseAssayClearedDate:03‐MAY‐1989BK890012‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Capture‐RReady‐Screen(Pooled)ClearedDate:21‐JUN‐1990BK890013‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Capture‐RReady‐Screen(I&II)ClearedDate:21‐JUN‐1990BK890014‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Capture‐RReady‐IdClearedDate:21‐JUN‐1990BK890022‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:FicinSolutionReagentSetClearedDate:26‐JAN‐1990BK920033‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:pHixClearedDate:21‐SEP‐1993BK950017‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:CaptureSClearedDate:24‐OCT‐1997BK950029‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Capture‐CMVClearedDate:22‐DEC‐1995BK960016‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Hemaglutination/DilutionStripsClearedDate:04‐JUN‐1997BK960017‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:ModifiedCapture‐RClearedDate:30‐JUN‐1998BK960018‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:ABSQCTestSystem/ABSQCTestSystemPlusClearedDate:21‐JUL‐1997BK960019‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:ABS2000ClearedDate:30‐JUN‐1998BK960020‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Capture‐RControlCellsClearedDate:04‐JUN‐1997BK000021‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Capture‐SSolidPhaseAssayClearedDate:22‐JUN‐2000BK000024‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:ABS2000,Version2software(2.
05.
00Aand2.
05.
00B)ClearedDate:03‐JUL‐2001BK010002‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:ABS2000(version1.
00.
30ASR‐1)ClearedDate:16‐FEB‐2001BK010020‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:ABS2000withVersion2.
05.
00ASoftwareABS2000withVersion2.
05.
00BSoftwareABS2000withVersion1.
00.
30ASR‐2SoftwareClearedDate:24‐SEP‐2001BK020053‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Capture‐RReadyIndicatorRedCellsClearedDate:27‐JAN‐2003BK020054‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Capture‐RControlCellsClearedDate:27‐JAN‐2003BK040010‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:MonoclonalControlClearedDate:23‐APR‐2004BK040013‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Galileoversion1.
3.
6SP4ClearedDate:23‐APR‐2004BK040014‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:GalileoQCCellClearedDate:22‐APR‐2004BK040023‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:DATPositiveControlCellClearedDate:23‐APR‐2004BK040024‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Capture‐RSelectSolidPhaseSystemClearedDate:28‐APR‐2004BK040057‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Checkcell(Weak)ClearedDate:06‐OCT‐2004BK050050‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Capture‐CMVGalileoAutomatedBloodBankSystemClearedDate:14‐NOV‐2005BK060009‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:GalileoAutomatedBloodBankSystemwithCapture‐SSyphilisScreeningAssayClearedDate:11‐APR‐2006BK060016‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:corQCTestSystemClearedDate:09‐MAY‐2006BK070013‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:MonoclonalControlClearedDate:14‐JUN‐2007BK070014‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:DATPositiveControlCellClearedDate:14‐JUN‐2007BK070015‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:WBcorQCClearedDate:14‐JUN‐2007BK070016‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:GalileoEchoAutomatedBloodBankSystemClearedDate:14‐JUN‐2007BK070039‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:corQCExtendClearedDate:28‐SEP‐2007BK070040‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:GalileoAutomatedBloodBankSystemwithassaystoperformredbloodcellphenotyingClearedDate:28‐SEP‐2007BK070051‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:Immucor'sWBcorQCClearedDate:16‐NOV‐2007BK070054‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:GalileowithReverseABOGroupAssayClearedDate:30‐NOV‐2007BK080070‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:AutomatedBloodBankAnalyzerClearedDate:05‐FEB‐2009BK090057‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:GalileoClearedDate:09‐JUL‐2010BK100001‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:GalileoNeoClearedDate:29‐APR‐2010BK100033‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:GalileoNeoClearedDate:23‐AUG‐2010BK110050‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:CheckcellClearedDate:03‐OCT‐2011BK110067‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:FMHRapidScreenClearedDate:22‐MAY‐2012BK120016‐0Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:ImmuLINK,version2.
0ClearedDate:14‐JUN‐2012BK120021‐0Immucor,Inc.
BK150333‐0BK170067‐0BK170132‐0BK170135‐0BK180220‐0BK180243‐0BK180247‐03130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:TPHAScreenClearedDate:24‐OCT‐2012Immucor,Inc.
3130GatewayDriveP.
O.
Box5625Norcross,GA30091‐5625TradeName:ImmuLINK‐V.
1.
7ClearedDate:19‐NOV‐2015Immucor,Inc.
3130GatewayDriveNorcross,GA30071TradeName:GalileoNeoClearedDate:19‐JUL‐2017Immucor,Inc.
3130GatewayDriveNorcross,GA30071TradeName:GalileoEchoClearedDate:27‐APR‐2018Immucor,Inc.
3130GatewayDriveNorcross,GA30071TradeName:EchoLumenaClearedDate:27‐APR‐2018Immucor,Inc.
3130GatewayDriveNorcross,GA30071TradeName:GalileoEchoClearedDate:17‐JUL‐2018Immucor,Inc.
3130GatewayDriveNorcross,GA30071TradeName:NEOIrisNeoIris‐Version3ClearedDate:07‐NOV‐2018Immucor,Inc.
3130GatewayDriveNorcross,GA30071TradeName:Capture‐CMVClearedDate:20‐NOV‐2018BK190337‐0Immucor,Inc.
3130GatewayDriveNorcross,GA30071TradeName:GalileoNEOClearedDate:19‐JUN‐2019BK200474‐0Immucor,Inc.
3130GatewayDriveNorcross,GA30071TradeName:NEOIrisClearedDate:12‐JUN‐2020BK200483‐0Immucor,Inc.
3130GatewayDriveNorcross,GA30071TradeName:EchoLumenaGalileoEcho(v.
2.
0)ClearedDate:22‐JUN‐2020BK200502‐0Immucor,Inc.
3130GatewayDriveNorcross,GA30071TradeName:GalileoNEOClearedDate:13‐OCT‐2020BK200542‐0Immucor,Inc.
3130GatewayDriveNorcross,GA30071TradeName:Capture‐CMV‐0066206,0066216ClearedDate:08‐FEB‐2021BK110054‐0Immunetics,Inc.
27DrydockAvenueBoston,MA02210‐2377TradeName:BacTx(R)BacterialDetectionKitforPlateletsClearedDate:11‐JUN‐2012BK130017‐0Immunetics,Inc.
27DrydockAvenueBoston,MA02210‐2377TradeName:BacTxReaderBacTxSoftwareBacTxBacterialDetectionKitforDetectionofBacteriainPlateletsClearedDate:12‐AUG‐2013BK170149‐0Immunetics,Inc.
27DrydockAvenueBoston,MA02210‐2377TradeName:BacTxBacterialDetectionKitsClearedDate:16‐APR‐2018BK910033‐0In‐TouchCompany101N700WestSaltLakeCity,UT84954TradeName:AltonDeanModel537BloodWarmerClearedDate:18‐NOV‐1992BK960068‐0Indico,Inc.
Suite1376325103StreetEdmonton,ALBERTACANADAT6H5H6TradeName:RadTagClearedDate:30‐OCT‐1996BK000008‐0Indico,Inc.
Suite1376325103StreetEdmonton,ALBERTACANADAT6H5H6TradeName:RadTagClearedDate:01‐MAR‐2000BK950064‐0Informatics4000KrusoWayPlaceBuilding3Suite210LakeOswego,OR97035TradeName:LifelineBloodBankDataManagementSystem,Release4.
2ClearedDate:01‐JUL‐1998BK950032‐0InformationDataManagement,Inc.
9701WestHigginsRoadRosemont,IL60018TradeName:AbbottDataManagementSystem,version3.
0.
2ClearedDate:18‐AUG‐1998ClearedUnderAbbottLaboratoriesBK950037‐0InformationDataManagement,Inc.
9701WestHigginsRoadRosemont,IL60018TradeName:Components&DistributionInformationSystem(CDIS)ClearedDate:26‐AUG‐1996BK950045‐0InformationDataManagement,Inc.
9701WestHigginsRoadRosemont,IL60018TradeName:DONORMANAGEMENTINFORMATIONSYSTEMSClearedDate:26‐AUG‐1996BK980020‐0InformationDataManagement,Inc.
9701WestHigginsRoadRosemont,IL60018TradeName:PlasmaCenterManagementSystem‐Version1.
0ClearedDate:31‐JUL‐1998BK980028‐0InformationDataManagement,Inc.
9701WestHigginsRoadRosemont,IL60018TradeName:PCMS‐version1.
1ClearedDate:04‐SEP‐1998BK990016‐0InformationDataManagement,Inc.
9701WestHigginsRoadRosemont,IL60018TradeName:SurroundSystem‐1.
0ClearedDate:27‐AUG‐1999BK990029‐0InformationDataManagement,Inc.
9701WestHigginsRoadRosemont,IL60018TradeName:PlasmaCenterManagementSystem(PCMS)Version1.
2ClearedDate:13‐OCT‐1999BK000016‐0InformationDataManagement,Inc.
9701WestHigginsRoadRosemont,IL60018TradeName:InformationDataManagementSurroundSystem‐2.
0ClearedDate:07‐APR‐2000BK990046‐0InformationDataManagement,Inc.
9701WestHigginsRoadRosemont,IL60018TradeName:PlasmaCenterManagementSystem(PCMS)‐Version2.
0ClearedDate:06‐JAN‐2000BK010028‐0InformationDataManagement,Inc.
9701WestHigginsRoadRosemont,IL60018TradeName:IDMSurroundSystem‐3.
0ClearedDate:05‐SEP‐2001BK020038‐0InformationDataManagement,Inc.
9701WestHigginsRoadRosemont,IL60018TradeName:SurroundSystem,Version3.
2ClearedDate:08‐OCT‐2002BK050014‐0InformationDataManagement,Inc.
9701WestHigginsRoadRosemont,IL60018TradeName:IDMPreludeSystem,Version1.
1ClearedDate:18‐JUL‐2005BK070031‐0InformationDataManagement,Inc.
9701WestHigginsRoadRosemont,IL60018TradeName:IDMSymphonySystem‐2.
0ClearedDate:13‐DEC‐2007BK860042‐0InstaCool,IncofNorthAmerica11300SandersDrive,Suite14RanchoCordova,CA95742TradeName:InstaCoolModelBP2502ClearedDate:04‐MAR‐1987BK900032‐0InstaCool,IncofNorthAmerica11300SandersDrive,Suite14RanchoCordova,CA95742TradeName:MPIIIClearedDate:30‐MAR‐1992BK910011‐0InstaCool,IncofNorthAmerica11300SandersDrive,Suite14RanchoCordova,CA95742TradeName:MT‐200FROZENPLASMATHAWERClearedDate:19‐DEC‐1991BK940019‐0InstaCool,IncofNorthAmerica11300SandersDrive,Suite14RanchoCordova,CA95742TradeName:HemopharmPB‐500PocketSealerClearedDate:26‐SEP‐1994BK850016‐0IntegratedDiagnostics,Inc.
1901SulphurSpringRoadBaltimore,MD1227TradeName:HLACOMPREHENSIVETRAYClearedDate:30‐DEC‐1985BK870018‐0IntegratedDiagnostics,Inc.
1901SulphurSpringRoadBaltimore,MD1227TradeName:INDXHLA‐DR,DQLymphocytePhenotypingTrayClearedDate:28‐OCT‐1987BK080006‐0IntelliDOTCorporation13520EveningCreekDriveNorth,Suite400SanDiego,CA92128TradeName:IntelliDOTBloodProductAdministrationClearedDate:13‐JUN‐2008BK820001‐0InternationalBusinessMachinesPrinceton,NJ08540TradeName:IBM2991ClearedDate:28‐JUN‐1982BK830003‐0InternationalBusinessMachinesPrinceton,NJ08540TradeName:IBM2991‐SingleUnitLeukocytesfromWholeBloodClearedDate:27‐MAY‐1983BK830020‐0InternationalBusinessMachinesPrinceton,NJ08540TradeName:Plasticfor2997Plasticfor2991ClearedDate:27‐OCT‐1983BK830024‐0InternationalBusinessMachinesPrinceton,NJ08540TradeName:Plasticfor2991Plasticfor2997ClearedDate:09‐MAR‐1984BK820020‐0InternationalEquipmentCompany300SecondAvenueNeedhamHeights,MA02194TradeName:IECCentra‐WCellWasherClearedDate:05‐APR‐1983BK940004‐0InternationalEquipmentCompany300SecondAvenueNeedhamHeights,MA02194TradeName:SeromaxClearedDate:08‐APR‐1994BK910018‐0InternationalSpecialtyProducts1361AlpsRoadWayne,NJ07470TradeName:RAD‐SUREBLOODIRRADIATIONLABELClearedDate:12‐MAR‐1992BK920035‐0InternationalSpecialtyProducts1361AlpsRd,Wayne,NJ07470TradeName:RAD‐Sure2500ClearedDate:01‐APR‐1993BK120048‐0Intra‐LockInternational6560WestRogersCircleBocaRaton,FL33487TradeName:Intra‐SpinSystemClearedDate:28‐JAN‐2013BK960054‐0JewettRefrigeratorCo.
,Inc.
2‐18LetchworthStreetBuffalo,NY14213‐1098TradeName:JewettModelsBPL13,BPL21,BPL25ClearedDate:08‐AUG‐1996BK960073‐0JewettRefrigeratorCo.
,Inc.
2‐18LetchworthStreetBuffalo,NY14213‐1098TradeName:ModelsBBR17,BBR25,BBR37&BBR55ClearedDate:30‐OCT‐1996BK960089‐0JewettRefrigeratorCo.
,Inc.
2‐18LetchworthStreetBuffalo,NY14213‐1098TradeName:JewettModelCT1ClearedDate:06‐FEB‐1997BK970001‐0JewettRefrigeratorCo.
,Inc.
2‐18LetchworthStreetBuffalo,NY14213‐1098TradeName:JewettModelCTF‐1ClearedDate:16‐APR‐1997BK970014‐0JewettRefrigeratorCo.
,Inc.
2‐18LetchworthStreetBuffalo,NY14213‐1098TradeName:JewettModelBBWM3ClearedDate:18‐JUL‐1997BK970028‐0JewettRefrigeratorCo.
,Inc.
2‐18LetchworthStreetBuffalo,NY14213‐1098TradeName:JewettModelBPL55ClearedDate:15‐OCT‐1997BK860037‐0Jouan,Inc.
Route8,Box1202;P.
O.
Box2716Winchester,VA22601TradeName:ModelLR5.
22centrifugeClearedDate:15‐DEC‐1986BK870001‐0Jouan,Inc.
Route8,Box1202;P.
O.
Box2716Winchester,VA22601TradeName:ModelGR4.
11centrifugeClearedDate:20‐FEB‐1987BK890027‐0Jouan,Inc.
Route8,Box1202;P.
O.
Box2716Winchester,VA22601TradeName:ModelKR4‐22CentrifugeClearedDate:02‐FEB‐1990BK000003‐0KawasumiLaboratories,Inc.
1900KStreetWashington,,DC20006TradeName:KawasumiLaboratoriesPhlebotomySeyClearedDate:20‐MAR‐2000BK170113‐0KawasumiLaboratories,Inc.
ShinagawaIntercityTowerB2‐15‐2KonanMinato‐KuTokyo,JAPAN108‐6109TradeName:KawasumiLaboratoriesBloodDrawingKit(BDK)System‐BK‐64AKawasumiLaboratoriesBloodDrawingKit(BDK)SystemClearedDate:27‐SEP‐2017BK080057‐0KaylightCorporation602AnacapaIrvine,CA92602TradeName:MyCellsAutologousPlateletPreparationKitClearedDate:25‐SEP‐2009BK200456‐0KedrionS.
p.
A.
Loc.
AiContiBarga,LuccaITALY55051TradeName:GeTrapClearedDate:20‐APR‐2020BK840005‐0KontronBloodBankSystems9PlymouthStreetEverett,MA02149TradeName:KontronMicrogroupamaticClearedDate:27‐JUN‐1984BK870012‐0KontronBloodBankSystems9PlymouthStreetEverett,MA02149TradeName:LHS‐500SamplerandDeliverySystemClearedDate:02‐NOV‐1987BK890008‐0KontronBloodBankSystems9PlymouthStreetEverett,MA02149TradeName:G‐1000G‐2000G‐2000MKIIClearedDate:30‐AUG‐1989BK040053‐0KorchekTechnologies,LLC770PlattsvilleRoadTrumbull,CT06611TradeName:CareChekPatientIdentificationSystem,CareChekTX‐version1ClearedDate:12‐AUG‐2005BK030037‐0KowaCompany,Ltd.
c/oQuintilesConsulting1801RockvillePike,Suite300Rockville,MD20852TradeName:LD‐2000LeukocyteCounterClearedDate:14‐JUN‐2004BK100024‐0Lab21HealthcareLtd184CambridgeScienceParkCambridge,CambridgeshireUNITEDKINGDOMCB40GA,UKTradeName:Lab21TPHAOCKitClearedDate:03‐AUG‐2010BK860031‐0Lab‐LineInstruments,Inc.
15thandBloomingdaleAvenuesMelrosePark,IL60160TradeName:Hema‐BathClearedDate:02‐MAR‐1987BK110055‐0Lattice,Inc.
1751SouthNapervilleRdSuite100Wheaton,IL60189TradeName:MediCopiaTransfusion‐v4.
1ClearedDate:06‐JAN‐2012BK860023‐0Level1Technologies,Inc.
160WeymouthStreetRockland,MA02370TradeName:Level1FluidWarmerClearedDate:25‐SEP‐1986BK920021‐0Level1Technologies,Inc.
160WeymouthStreetRockland,MA02370TradeName:A/VRewarmingProceduralKitGentilelloTechniqueClearedDate:29‐JAN‐1993BK940056‐0Level1Technologies,Inc.
160WeymouthStreetRockland,MA02370TradeName:LevelIFluidWarmerClearedDate:27‐DEC‐1994BK020043‐0Level1Technologies,Inc.
160WeymouthStreetRockland,MA02370TradeName:level1fluidwarmingsystemClearedDate:16‐JUN‐2003BK070038‐0LifeTechnologiesCorporation9099NorthDeerbrookTrailBrownDeer,WI53223TradeName:AllSetGoldSSPClearedDate:26‐SEP‐2007ClearedUnderInvitrogenCorporationBK070041‐0LifeTechnologiesCorporation9099NorthDeerbrookTrailBrownDeer,WI53223TradeName:DynaChipHLAAntibodyAnalysisSystemClearedDate:30‐APR‐2008ClearedUnderInvitrogenCorporationBK070046‐0LifeTechnologiesCorporation9099NorthDeerbrookTrailBrownDeer,WI53223TradeName:UniMatchPlusVersion4.
0ClearedDate:27‐SEP‐2007ClearedUnderInvitrogenCorporationBK110038‐0LifeTechnologiesCorporation9099NorthDeerbrookTrailBrownDeer,WI53223TradeName:SeCoreHLASequencingSystemuTypeDxHLAAnalysisSoftwarev1.
0ClearedDate:05‐FEB‐2013BK110039‐0LifeTechnologiesCorporation9099NorthDeerbrookTrailBrownDeer,WI53223TradeName:3500Dx/3500xLDxGeneticAnalyzer8CS2and3500DxSeriesSoftwareClearedDate:05‐FEB‐2013BK080017‐0LifeSouthCommunityBloodCentersInc.
4039NewberryRoadGainesville,FL32607TradeName:IntegratedBloodBankInformationSystem(IBBIS)RegistrationModule‐v1.
0ClearedDate:05‐AUG‐2008BK090064‐0LifeSouthCommunityBloodCentersInc.
4039NewberryRoadGainesville,FL32607TradeName:IntegratedBloodBankInformationSystemClearedDate:08‐DEC‐2009BK130054‐0LifeSouthCommunityBloodCentersInc.
4039NewberryRoadGainesville,FL32607TradeName:IntegratedBloodBankInformationSystem,version3.
0(IBBIS)ClearedDate:17‐JAN‐2014BK160004‐0LifeSouthCommunityBloodCentersInc.
4039NewberryRoadGainesville,FL32607TradeName:IntegratedBloodBankInformationSystem(IBBIS),Version4.
0ClearedDate:29‐MAR‐2016BK830006‐0LiquidCrystalProducts,Inc.
724AlgonquinRoadArlingtonHeights,IL60005TradeName:HemoTempIIBloodTemperatureIndicatorClearedDate:04‐MAY‐1983BK990013‐0Ljungberg&KogelC/OKamm&Associates333MilfordRd.
Deerfield,IL60015TradeName:Biomixer330&Biomixer323ClearedDate:07‐JUL‐1999BK090010‐0Ljungberg&KogelC/OKamm&Associates333MilfordRd.
Deerfield,IL60015TradeName:BiomixerBM330withXBee(Wireless)OptionClearedDate:17‐JUL‐2009BK180232‐0MAK‐SYSTEMSAInternationalGroup10AvenuedelaGrande‐Armee,ParisFRANCE75017TradeName:PatientHealthSoftware(P.
H.
S)‐2.
0ClearedDate:18‐OCT‐2018BK960050‐0MAK‐SystemZ.
I.
ParisNordII14,RuedelaPerdrix95946RoissyC.
D.
G.
CEDEX,FRANCEB.
P.
50035TradeName:ProgesaClearedDate:10‐DEC‐1998BK060035‐0MAK‐System10AvenuedelaGrandeArmee75017Paris,FRANCE75017TradeName:PatientHealthSoftware‐1.
0ClearedDate:09‐MAY‐2007BK070062‐0MAK‐System10AvenuedelaGrandeArmee75017Paris,FRANCE75017TradeName:PROGESA‐4.
4hClearedDate:26‐OCT‐2007BK080002‐0MAK‐System10AvenuedelaGrandeArmee75017Paris,FRANCE75017TradeName:ePROGESA‐5.
0.
1ClearedDate:13‐MAY‐2008BK960029‐0MEDITECHMedicalInformationTechnology,Inc.
MEDITECHCircleWestwood,MA02090TradeName:MEDITECHClearedDate:19‐MAR‐1999BK980046‐0MEDITECHMedicalInformationTechnology,Inc.
MEDITECHCircleWestwood,MA02090TradeName:MagicClientServer‐5.
1ClearedDate:08‐FEB‐2000BK060029‐0MEDITECHMedicalInformationTechnology,Inc.
MEDITECHCircleWestwood,MA02090TradeName:MEDITECHMAGICBloodBankSoftware‐4.
9ClearedDate:06‐FEB‐2007BK080037‐0MEDITECHMedicalInformationTechnology,Inc.
MEDITECHCircleWestwood,MA02090TradeName:MEDITECHClientServerBloodbankmodule5.
6‐v5.
6ClearedDate:30‐OCT‐2008BK080061‐0MEDIWAREINFORMATIONSYSTEMS,INC.
11711West79thStreetLenexa,KS66214TradeName:HCLLDonorClearedDate:02‐DEC‐2008BK100043‐0MEDIWAREINFORMATIONSYSTEMS,INC.
11711West79thStreetLenexa,KS66214TradeName:LifeTrak/Donor‐4.
6.
0ClearedDate:21‐OCT‐2010BK100057‐0MEDIWAREINFORMATIONSYSTEMS,INC.
11711West79thStreetLenexa,KS66214TradeName:LifeTrak/LabandDistribution‐4.
6.
0ClearedDate:16‐NOV‐2010BK100069‐0MEDIWAREINFORMATIONSYSTEMS,INC.
11711West79thStreetLenexa,KS66214TradeName:LifeTrak/Plasma‐1.
0.
0ClearedDate:04‐MAR‐2011BK980027‐0MEDSEPCorporation330TurnbullCanyonRoadCityofIndustry,CA91745TradeName:Transfer/FreezingBagSetClearedDate:26‐MAR‐1999ClearedUnderMEDSEPCorp.
BK980030‐0MEDSEPCorporation330TurnbullCanyonRoadCityofIndustry,CA91745TradeName:MedsepFreezingbagClearedDate:29‐AUG‐1998ClearedUnderMEDSEPCorp.
BK980038‐0MEDSEPCorporation330TurnbullCanyonRoadCityofIndustry,CA91745TradeName:CellWash/InfusionBagSetClearedDate:13‐JUL‐1999ClearedUnderMEDSEPCorp.
BK120026‐0MEDSEPCorporation1630IndustrialParkStreetCovina,CA91722TradeName:PallCelerisfPCSystemClearedDate:29‐JUN‐2012BK930021‐0MIGADASINC482HudsonTerraceEnglewoodCliffs,NY07632TradeName:SamplinkClearedDate:16‐NOV‐1993BK970022‐0MIGADASINC482HudsonTerraceEnglewoodCliffs,NY07632TradeName:samplinkClearedDate:18‐SEP‐1997BK910007‐0MMED60919thAvenue,S.
W.
Rochester,MN55902TradeName:MMEDVaporCondensationBloodWarmerClearedDate:16‐MAR‐1992BK910004‐0MPI/Dupaco,Inc.
2620TempleHeightsDriveOceanside,CA92056TradeName:DupacoBlood/FluidWarmingCuffSetClearedDate:21‐FEB‐1992BK030008‐0MacoProductionsS.
A.
S.
c/oHoppeRegulatoryConsultants2335masseyLaneDecatur,GA30033TradeName:LeucolabLCG2LeukoreductionSystemforRedBloodCellsClearedDate:02‐MAY‐2003BK050041‐0MacoProductionsS.
A.
S.
c/oHoppeRegulatoryConsultants2335masseyLaneDecatur,GA30033TradeName:LeucolabLCG2LeukoreductionSystemforRedBloodCellsClearedDate:12‐OCT‐2005BK080060‐0MacoProductionsS.
A.
S.
1733CantonLaneSuite103Marietta,GA30062‐2679TradeName:LeucolabLCG2LeukoreductionSystemforAS‐1,AS‐3,andAS‐5RedBloodCellsClearedDate:14‐JAN‐2009BK120071‐0MacoProductionsS.
A.
S.
3675CrestwoodParkwaySuite260Duluth,GA30096TradeName:LeucolabLCG2LeukoreductionSystemsforAS‐1RedBloodCellsLeucolabLCG2LeukoreductionSystemsforAS‐1andAS‐3RedBloodCellsLeucolabLCG2LeukoreductionSystemsforAS‐1,AS‐3andAS‐5RedBloodCellsClearedDate:22‐FEB‐2013BK160095‐0MacoProductionsS.
A.
S.
200chausseeFernandForest,TourcoingFRANCE59200TradeName:MacoMixHM20andoptionalHemolog6SoftwareClearedDate:11‐AUG‐2017BK170085‐0MacoProductionsS.
A.
S.
200chausseeFernandForest,TourcoingFRANCE59200TradeName:MacoPressSmart(MPS)andDMSPlusClearedDate:09‐NOV‐2017BK180306‐0MacoProductionsS.
A.
S.
200chausseeFernandForest,TourcoingFRANCE59200TradeName:MacoPressSmartSmarterandDMSPlusClearedDate:24‐JAN‐2019BK960075‐0MallinckrodtMedical,Inc.
675McDonnellBoulevardSt.
Louis,MO63134TradeName:AltonDeanFluidWarmer,FW‐537ClearedDate:28‐FEB‐1997BK090051‐0McKessonProviderTechnologies5995WindwardParkwayAlpharetta,GA30005TradeName:HorizonMobileCareTransfusionClearedDate:28‐MAY‐2010BK180219‐0MedicalInformationTechnology,Inc.
MeditechCircleWestwood,MA02090TradeName:MEDITECHExpanseBloodBankClearedDate:12‐SEP‐2018BK920031‐0MedicalMarketingConsultants3BethesdaMetroCenter,Suite750Bethesda,MD20814TradeName:sHLA‐STATB27ELISAforHLA‐B27TypingClearedDate:20‐AUG‐1993BK140092‐0MedionGrifolsDiagnosticsAGBonnstrasse9Duedingen,TradeName:DGGelExtendedControlClearedDate:11‐APR‐2014BK180280‐0MedionGrifolsDiagnosticsAGBonnstrasse9Duedingen,TradeName:DGGelEssentialControlClearedDate:17‐JAN‐2019BK980034‐0MediwareInformationSystems,Inc.
1121OldWaltWhitmanRoadMelville,NY11747TradeName:HemocareBloodBankManagementSystem‐Revision5.
2ClearedDate:10‐DEC‐1998BK010052‐0MediwareInformationSystems,Inc.
9000HarryHinesBlvdDallas,TX75235TradeName:LifeTrakLab‐2.
03ClearedDate:17‐JUN‐2002BK020046‐0MediwareInformationSystems,Inc.
900OakmontLaneWestmont,IL60659TradeName:HemocareLifeLine‐Version,1.
0ClearedDate:14‐FEB‐2003BK030078‐0MediwareInformationSystems,Inc.
4545FullerDrive,Ste320Irving,TX75038TradeName:HCLL‐2.
6ClearedDate:08‐APR‐2004BK040047‐0MediwareInformationSystems,Inc.
4545FullerDrive,Ste320Irving,TX75038TradeName:InstrumentInterfaceEngine‐1.
0ClearedDate:16‐JUL‐2004BK050011‐0MediwareInformationSystems,Inc.
4545FullerDrive,Ste320Irving,TX75038TradeName:HCLLDonor‐1.
0ClearedDate:10‐MAY‐2005BK060019‐0MediwareInformationSystems,Inc.
4545FullerDrive,Ste320Irving,TX75038TradeName:LifeTrak/Donor‐3.
01ClearedDate:21‐JUN‐2006BK080049‐0MediwareInformationSystems,Inc.
1900SpringRoad,Suite450OakBrookServiceCenterOakBrook,IL60523TradeName:HCLLTransfusion,v3.
0ClearedDate:22‐OCT‐2008BK120036‐0MediwareInformationSystems,Inc.
1900SpringRoad,Suite450OakBrookServiceCenterOakBrook,IL60523TradeName:HCLL(TM)Transfusion2012ClearedDate:19‐SEP‐2012BK120039‐0MediwareInformationSystems,Inc.
1900SpringRoad,Suite450OakBrookServiceCenterOakBrook,IL60523TradeName:LifeTrak(R)2012ClearedDate:05‐SEP‐2012BK160066‐0MediwareInformationSystems,Inc.
11711West79thStLenexa,KS66214TradeName:HCLL(TM)Transfusion2015R2ClearedDate:30‐SEP‐2016BK180200‐0MediwareInformationSystems,Inc.
11711West79thStLenexa,KS66214TradeName:LifeTrak2018ClearedDate:03‐JUL‐2018BK910019‐0MedsepCorporation2200NorthernBoulevardEastHills,NY11548‐1289TradeName:PallBPF4BLeukocyteRemovalBloodProcessingFilterwihtAttachedTubingandBloodBagClearedDate:16‐JAN‐1992ClearedUnderPallBioMedicalBK920023‐0MedsepCorporation2200NorthernBoulevardEastHills,NY11548‐1289TradeName:PallAutostopLeukocyteRemovalPlateletFilterwithTubingClearedDate:26‐OCT‐1992ClearedUnderPallBioMedicalBK940018‐0MedsepCorporation2200NorthernBoulevardEastHills,NY11548‐1289TradeName:PallAutoprocessorTMSystemClearedDate:07‐SEP‐1994ClearedUnderPallBioMedicalBK100058‐0MedsepCorporation1630INDUSTRIALPARKCOVINA,CA91722TradeName:ThePallCelerisfPCSystemClearedDate:24‐FEB‐2011BK010032‐0Medserv,Inc.
71SouthBedfordRoadMountKisco,NY10549TradeName:PlasmapheresisDataSystemIII‐1.
0ClearedDate:05‐FEB‐2002BK030040‐0MedtronicSofamorDanek1800PyramidPlaceMemphis,TN38132TradeName:MagellanAutologousPlateletSeparationSystemClearedDate:03‐SEP‐2003BK040068‐0MedtronicSofamorDanek1800PyramidPlaceMemphis,TN38132TradeName:MagellanAutologousPlateletSeparatorSystemClearedDate:09‐NOV‐2004BK940010‐0MerciaDiagnosticsLimitedMerciaHouse,BroadfordParkShalford,GuildfordGU48EW,UNITEDKINGDOMTradeName:CAPTIATMSyphilis‐GClearedDate:03‐JAN‐1995BK920004‐0MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MGRModelERB‐5‐0378ClearedDate:12‐MAR‐1992BK920013‐0MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MTSDiluent2ClearedDate:29‐SEP‐1993BK920014‐0MicroTypingSystemsInc.
BK920016‐0BK920030‐0BK930030‐0BK940034‐0BK950025‐0BK950026‐0BK950027‐0BK950028‐01295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MTSCentrifugeClearedDate:29‐SEP‐1993MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MTSBufferedGelCardClearedDate:29‐SEP‐1993MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MTSDiluent1ClearedDate:29‐SEP‐1993MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MTSDiluent2PlusClearedDate:12‐JAN‐1994MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MTSControlCardClearedDate:27‐JUL‐1994MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MTSIncubatorClearedDate:08‐MAY‐1995MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MTSWorkTableClearedDate:15‐MAY‐1995MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:ID‐PipetorClearedDate:01‐JUN‐1995MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MTSDispenser(0.
5mland1.
0ml)ClearedDate:27‐JUN‐1995BK960013‐0MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MTS‐CentrifugeModelNU9310ClearedDate:15‐APR‐1996BK980016‐0MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:ID‐TipmasterClearedDate:29‐OCT‐1998BK990012‐0MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MTSReaderMClearedDate:19‐NOV‐1999BK000018‐0MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MTSReaderSAClearedDate:21‐NOV‐2000BK010021‐0MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MTSIncubatorIIClearedDate:01‐OCT‐2001BK030023‐0MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:OrthoProVue,SoftwareVersion:2.
10ClearedDate:14‐MAY‐2003BK090013‐0MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:ORTHOProVue,version3.
1ClearedDate:04‐JUN‐2009BK110029‐0MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:OrthoProVueAnalyzerVersion3.
1Patch1(V3.
1.
1)ClearedDate:14‐JUL‐2011BK150280‐0MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MTSBufferedGelCardMTSMonoclonalControlCardClearedDate:14‐AUG‐2015BK160061‐0MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MTSTMBufferedGelCardMTSTMMonoclonalControlCardClearedDate:21‐OCT‐2016BK190339‐0MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MTSBufferedGelCardClearedDate:08‐JUL‐2019BK190400‐0MicroTypingSystemsInc.
1295S.
W.
29thAve.
PompanoBeach,FL33069TradeName:MTSBufferedGelCardClearedDate:17‐DEC‐2019BK840023‐0Microdrop,Incorporation2227CorinthAve.
LosAngeles,CA90064TradeName:LeukocyteTypingSerumTraysClearedDate:12‐OCT‐1984BK840013‐0Microdrop,Incorporation2227CorinthAve.
LosAngeles,CA90064TradeName:LambdaCellTrayClearedDate:20‐NOV‐1984BK100008‐0Micronics8463154thAvenueNERedmond,WA98052TradeName:ABORhCardClearedDate:30‐APR‐2010BK910034‐0MicrowaveMedicalSystem310‐312SchoolSt.
Acton,MA01720TradeName:QWIK‐1Bld.
andPlasmaWarmerClearedDate:29‐JUL‐1993BK940003‐0MicrowaveMedicalSystem310‐312SchoolSt.
Acton,MA01720TradeName:Qwik‐1TM‐500ClearedDate:24‐FEB‐1994BK970044‐0MicrowaveMedicalSystem310‐312SchoolSt.
Acton,MA01720TradeName:ThermoStat900ClearedDate:23‐JAN‐1998BK970045‐0MicrowaveMedicalSystem310‐312SchoolSt.
Acton,MA01720TradeName:ThermoStat900Blood&IVFluidAdm.
SetClearedDate:06‐MAR‐1998BK860016‐0Miles,Inc.
4thandParkerStreets,P.
O.
Box1986Berkeley,CA94701‐1986TradeName:PENTEXMOD‐U‐CYTEII&VIIIClearedDate:17‐APR‐1987BK090020‐0MiltenyiBiotec,Inc.
120PresidentialWaySuite305Woburn,MA01801TradeName:CryoMACSFreezingBagClearedDate:13‐JAN‐2010BK030065‐0MississippiBloodServices,Inc.
1995LakelandDriveJackson,MS39216TradeName:WebLabOnlineLaboratorySystem‐2.
0ClearedDate:22‐DEC‐2003BK040065‐0MisysHealthcareSystems4801EastBroadwayBoulevardTucson,AZ85711TradeName:MisysLaboratoryBloodBankandBloodDonor‐6.
0.
1ClearedDate:22‐OCT‐2004BK940044‐0MonaBarres516SeanDr.
Metaire,LA70005TradeName:VacMaticIhs3‐15ClearedDate:07‐SEP‐1994BK060014‐0MosumTechnologyIndiaPVTLTD55NorthernBlvd,Suite200GreatNeck,NY11021TradeName:PowerBANKEnterpriseEdition‐version1.
0ClearedDate:30‐MAR‐2007BK920024‐0MurexBiologicals,Inc.
1107I‐45SouthConroe,TX77301TradeName:MurexPEGPotentiatorforAntibodyDetectionClearedDate:01‐JUN‐1993BK910016‐0NPBIRundeZZ41,7881HMEmmerCompascuumEmmer‐Compascumm,NETHERLANDSTradeName:CompomatClearedDate:30‐MAR‐1992BK930018‐0NPBIRundeZZ41,7881HMEmmerCompascuumEmmer‐Compascumm,NETHERLANDSTradeName:BloodCollectionMixerMW5001ClearedDate:24‐JUL‐1994BK930020‐0NPBIRundeZZ41,7881HMEmmerCompascuumEmmer‐Compascumm,NETHERLANDSTradeName:BiotransSeparatorClearedDate:27‐JUL‐1994BK940061‐0NPBIRundeZZ41,7881HMEmmerCompascuumEmmer‐Compascumm,NETHERLANDSTradeName:ComposealMobileandComposealUniversalClearedDate:26‐JAN‐1995BK950035‐0NPBIRundeZZ41,7881HMEmmerCompascuumEmmer‐Compascumm,NETHERLANDSTradeName:CompocoolClearedDate:27‐SEP‐1995BK960084‐0NPBIRundeZZ41,7881HMEmmerCompascuumEmmer‐Compascumm,NETHERLANDSTradeName:GambroHemofreezeBagClearedDate:28‐MAY‐1998BK940053‐0Nanoentek,Inc.
300WashingtonSt.
,STE416Newton,MA02458TradeName:OlympusPKSystemClearedDate:29‐NOV‐1995ClearedUnderSchiff&CompanyBK120015‐0Nanoentek,Inc.
300WashingtonSt.
,STE416Newton,MA02458TradeName:ADAM‐rWBCClearedDate:24‐JUL‐2012BK120068‐0Nanoentek,Inc.
300WashingtonSt.
,STE416Newton,MA02458TradeName:ADAM‐rWBCClearedDate:05‐DEC‐2012BK180283‐0Nanoentek,Inc.
12f,5,Digital‐Ro26‐GilGuro‐Gu,SeoulKOREA,SOUTH152‐740TradeName:ADAMIICD34SystemClearedDate:09‐AUG‐2019BK200525‐0Nanoentek,Inc.
85114,Seohaero,PaltanmyeonHwaseongsi,GyeonggidoKOREA,SOUTH18521TradeName:ADAM‐rWBCHTSystemADAM‐rWBCHTSystemwithADAM‐rWBCKitClearedDate:01‐DEC‐2020BK950042‐0NationalHospitalSpecialties104JohnsonAvenueHackensack,NJ07601TradeName:GenesisBloodCollectionMixerClearedDate:19‐SEP‐1995BK840016‐0Neocyte199WeymouthStreetRockland,MA02370TradeName:NEOPACKSystemClearedDate:25‐JUN‐1985BK050032‐0NeotericTechnologyLtd205‐1099W.
8thAve.
Vancouver,BritishColumbiaCANADAV6H1C3TradeName:BloodTrackSafeTx‐Version2.
0ClearedDate:16‐AUG‐2005BK050059‐0NeotericTechnologyLtd205‐1099W.
8thAve.
Vancouver,BritishColumbiaCANADAV6H1C3TradeName:BloodTrackCourier‐3.
2ClearedDate:13‐DEC‐2005BK060041‐0NeotericTechnologyLtd205‐1099W.
8thAve.
Vancouver,BritishColumbiaCANADAV6H1C3TradeName:BloodTrack‐4.
1ClearedDate:12‐OCT‐2006BK180301‐0NewmarketBiomedicalLtdUnit1LanwadesBusinessPark,KentfordUNITEDKINGDOMCB87PNTradeName:PK7400TPHAControlsPK7400TPHAReagentClearedDate:01‐AUG‐2019BK920020‐0Nor‐Lake,Inc.
SecondandElmStr.
P.
O.
Box248Hudson,WI54016TradeName:NSBR211,NSBR482,andNSB763BloodRefrigeratorsClearedDate:19‐JAN‐1993BK930002‐0Nor‐Lake,Inc.
SecondandElmStr.
P.
O.
Box248Hudson,WI54016TradeName:NSBR61(Nor‐LakeScientificBloodBank,6ftSingleDoor)ClearedDate:13‐APR‐1995BK930003‐0Nor‐Lake,Inc.
SecondandElmStr.
P.
O.
Box248Hudson,WI54016TradeName:NSBR83(Nor‐LakeScientificBloodBank,8ftDoubleDoor)ClearedDate:13‐APR‐1995BK930004‐0Nor‐Lake,Inc.
SecondandElmStr.
P.
O.
Box248Hudson,WI54016TradeName:NSBF211(Nor‐LakeScientificFreezers,21ftSingleDoor)ClearedDate:13‐APR‐1995BK930005‐0Nor‐Lake,Inc.
SecondandElmStr.
P.
O.
Box248Hudson,WI54016TradeName:NSBF482(Nor‐LakeScientificPlasmaFreezers,48ftDoubleDoor)ClearedDate:13‐APR‐1995BK930006‐0Nor‐Lake,Inc.
SecondandElmStr.
P.
O.
Box248Hudson,WI54016TradeName:NSBF61(Nor‐LakeScientificPlasmaFreezer,6ftSingleDoor)ClearedDate:13‐APR‐1995BK900023‐0NorthAmericanBiologicals,Inc.
16500N.
W.
15thAvenueMiami,FL33169TradeName:QC‐HIVClearedDate:13‐NOV‐1991BK910006‐0NorthAmericanBiologicals,Inc.
16500N.
W.
15thAvenueMiami,FL33169TradeName:QC‐HepatitisClearedDate:12‐MAR‐1992BK920015‐0NorthAmericanBiologicals,Inc.
16500N.
W.
15thAvenueMiami,FL33169TradeName:VirocheQC1ClearedDate:20‐MAY‐1993BK910028‐0NorthAmericanTechnicalServicesCorp.
407EMainSt.
PortJefferson,NY11777TradeName:ASTOTHERM/ASTOTUBEClearedDate:13‐JUL‐1992BK110060‐0NovartisVaccinesandDiagnostics,Inc.
4560HortonSt.
Emeryville,CA94608‐2916TradeName:PROCLEIXNATTRACKERVersion3.
0SoftwareClearedDate:01‐DEC‐2011BK930023‐0Nu‐Quest,Inc.
1031MeadowviewDriveWebbCity,MO64870TradeName:LittlePigStickerClearedDate:24‐FEB‐1994BK830017‐0Nuclear‐MedicalLaboratories,Division1800HurdDriveIrving,TX75061TradeName:Hepa‐SHureClearedDate:07‐OCT‐1983BK080022‐0OlerupSSPABHasselstigen1SE13333Saltsjobaden,SWEDENTradeName:OlerupSSPHLATypingKitsClearedDate:20‐FEB‐2009BK090042‐0OlerupSSPABHasselstigen1SE13333Saltsjobaden,SWEDENTradeName:OlerupSSPHLATypingKitsClearedDate:11‐SEP‐2009BK010040‐0OlympusAmericaInc.
,DiagnosticSystemsDivision3131WestRoyalLaneIrving,TX75063‐3104TradeName:OlympusPK7200AutomatedMicroplateSystemClearedDate:25‐OCT‐2001BK020024‐0OlympusAmericaInc.
,DiagnosticSystemsDivision3131WestRoyalLaneIrving,TX75063‐3104TradeName:OlympusPK7200AutomatedMicroplateSystemClearedDate:08‐JUL‐2002BK030009‐0OlympusAmericaInc.
,DiagnosticSystemsDivision3131WestRoyalLaneIrving,TX75063‐3104TradeName:OlympusPK7200AutomatedMicroplateSystemClearedDate:03‐MAR‐2003BK040003‐0OlympusAmericaInc.
,DiagnosticSystemsDivision3131WestRoyalLaneIrving,TX75063‐3104TradeName:OlympusPK7200AutomatedMicroplateSystemClearedDate:06‐FEB‐2004BK040070‐0OlympusAmericaInc.
,DiagnosticSystemsDivision3131WestRoyalLaneIrving,TX75063‐3104TradeName:TangoAutomatedBloodBankAnalyzerSystemClearedDate:22‐MAR‐2005BK050076‐0OlympusAmericaInc.
,DiagnosticSystemsDivision3131WestRoyalLaneIrving,TX75063‐3104TradeName:TANGOAutomatedBloodBankAnalyzerSystem(HWVersion02/SWVersion3.
0)ClearedDate:16‐DEC‐2005BK060024‐0OlympusAmericaInc.
,DiagnosticSystemsDivision3131WestRoyalLaneIrving,TX75063‐3104TradeName:OlympusBromelinOlympusPK7300AutomatedMicroplateSystemOlympusSystemControlClearedDate:14‐MAY‐2007BK060034‐0OlympusAmericaInc.
,DiagnosticSystemsDivision3131WestRoyalLaneIrving,TX75063‐3104TradeName:TANGOAutomatedBloodBankAnalyzerSystemClearedDate:28‐AUG‐2006BK090036‐0OlympusAmericaInc.
,DiagnosticSystemsDivision3500CorporateParkwayCenterValley,PA18034TradeName:OlympusPK7300AutomatedMicroplateSystemClearedDate:13‐JAN‐2010BK860004‐0OlympusCorporation4NevadaDriveLakeSuccess,NY11042TradeName:OlympusPK7100ClearedDate:14‐MAY‐1986BK870025‐0OlympusCorporation4NevadaDriveLakeSuccess,NY11042TradeName:OlympusPK7100AutomatedBloodGroupingSystemClearedDate:09‐OCT‐1987BK890030‐0OlympusCorporation4NevadaDriveLakeSuccess,NY11042TradeName:SynthEIASoftwareSystemClearedDate:23‐JAN‐1991BK930024‐0OlympusCorporation4NevadaDriveLakeSuccess,NY11042TradeName:OlympusPK7200BloodGroupingAnalyzerClearedDate:26‐JAN‐1994BK140093‐0OmrixBiopharmaceuticalsLtd.
POBox151,Route22WestSomerville,NJ08876‐0151TradeName:EvicelApplicationDeviceClearedDate:03‐SEP‐2014BK120014‐0OneLambda,Inc21001KittridgeStCanogaPark,CA91303TradeName:HLAFusionSoftware,Version3.
0ClearedDate:18‐DEC‐2012BK120024‐0OneLambda,Inc21001KittridgeStCanogaPark,CA91303TradeName:LABType(R)SSODNATypingTestsforusewithLABScanTM3DClearedDate:20‐DEC‐2012BK130009‐0OneLambda,Inc21001KittridgeStCanogaPark,CA91303TradeName:LABScreenforusewithLABScan(TM)3DClearedDate:06‐NOV‐2013BK140141‐0OneLambda,Inc21001KittridgeStCanogaPark,CA91303TradeName:LABScreen(R)MultiClearedDate:25‐NOV‐2014BK910021‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:LifesourceFlashBagClearedDate:08‐JUN‐1992BK920007‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:LambdaMonoclonalTrayClassIandIIClearedDate:28‐DEC‐1992BK920009‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:Anti‐B27FITCConjugatedMonoclonalAntibodyClearedDate:28‐MAR‐1997BK960011‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:LambdaAntigenTrayClearedDate:03‐JUL‐1997BK960053‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:Anti‐B27FITC/CD3PEConjugatedMonoclonalAntibodyClearedDate:30‐OCT‐1996BK960062‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:MicroSSPHLAClassIIDNATypingKitClearedDate:11‐FEB‐1998BK980015‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:FlowPRAClearedDate:23‐JUL‐1999BK020055‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:LABTYPESSOTypingTestClearedDate:04‐FEB‐2003BK030069‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:LABScreenProductsforusewithLABScan100flowanalyzerClearedDate:31‐DEC‐2003BK040049‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:LabTypeVisualClearedDate:09‐AUG‐2004BK050008‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:LABScreenSoftwareClearedDate:08‐JUL‐2005BK050070‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:HLAVisualSoftwareversion1.
0ClearedDate:30‐JAN‐2006BK050071‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:HLAToolsSoftwareversion1.
0ClearedDate:30‐JAN‐2006BK070070‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:HLAFusionSoftwarev1.
0ClearedDate:10‐MAR‐2008BK080071‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:LABScreenMultiClearedDate:10‐APR‐2009BK100068‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:HNAGenotypingTraysClearedDate:25‐AUG‐2011BK160017‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:HLAFusionClearedDate:08‐MAR‐2017BK160018‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:LABTypeTMXRandCWDDNATypingTestClearedDate:06‐MAR‐2017BK170053‐0OneLambda,Inc.
21001KittridgeSt.
CanogaPark,CA91303TradeName:LABTypeCWDClassICLocusTypingTestLABTypeCWDClassICLocusTypingTest‐20testsLABTypeXRClassICLocusTypingTestLABTypeXRClassICLocusTypingTest‐20testsClearedDate:05‐OCT‐2017BK200546‐0OneLambda,Inc.
22801RoscoeBlvdWestHills,CA92304TradeName:LABScreenMultiClearedDate:12‐JAN‐2021BK190322‐0OrSenseLtd17Ha'MefalsimStPetahTikva,KiryatArieISRAEL4951447TradeName:NBM‐200PulseOximeterandHemoglobinMonitorClearedDate:09‐MAY‐2019BK030036‐0OriGenBioMedical7000BurlesonRoad,Bldg.
DAustin,TX78744TradeName:OriGenCryostoreFreezingBagsClearedDate:01‐OCT‐2003BK140116‐0OriGenBioMedical7000BurlesonRoad,BuildingDAustin,TX78744TradeName:OrigenTransferBagClearedDate:19‐OCT‐2016BK180278‐0OriGenBioMedical7000BurlesonRoad,BuildingDAustin,TX78744TradeName:OriGenCryostoreMulti‐ChamberFreezingBagsClearedDate:21‐NOV‐2018BK820003‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:ORTHOConfidenceSystemClearedDate:10‐AUG‐1982BK820006‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:SimwashClearedDate:13‐APR‐1983BK830023‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:TYTEMTypingandDetectionSystemClearedDate:08‐DEC‐1983BK840017‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:ORTHOCellSuspensionTubeClearedDate:16‐NOV‐1984BK890021‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:OrthoConfidenceSystemClearedDate:23‐OCT‐1989BK920034‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:OrthoBioVueSystemClearedDate:09‐MAY‐1995BK960003‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:OrthoSummittSystemClearedDate:19‐OCT‐1998BK960052‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:OrthoSummitProcessorClearedDate:19‐OCT‐1998BK990030‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:OrthoLabwithOrthoLabIC(InstrumentConcentrator)ClearedDate:03‐APR‐2000BK050044‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:GeneticSystemsHIV‐1/HIV‐2PLUSOOrthoAssayProtocolDiskClearedDate:03‐NOV‐2006BK050046‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:GeneticSystemsHBsAgEIA3.
0OrthoAssayProtocolDiskClearedDate:13‐JAN‐2006BK070028‐0Ortho‐ClinicalDiagnostics,Inc.
100IndigoCreekDriveRochester,NY14626‐5101TradeName:VITROSImmunodiagnosticProductsAnti‐HIV1+2ControlsClearedDate:10‐APR‐2008BK090074‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:OrthoSummitSystemClearedDate:27‐MAY‐2009BK100040‐0Ortho‐ClinicalDiagnostics,Inc.
100IndigoCreekDriveRochester,NY14626‐5101TradeName:VITROSImmunodiagnosticsProductsAnti‐HIV1+2ControlsClearedDate:22‐JUL‐2010BK100061‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:ORTHOVERSEIAPipetteraspartoftheORTHOSummitSystemClearedDate:28‐OCT‐2010BK110026‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:OrthoSummitSystem(OSS)ClearedDate:28‐JUN‐2011BK120006‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:ORTHOVERSEIAPipetterasPartoftheORTHOSummitSystem(OSS)v3.
0ClearedDate:15‐MAR‐2012BK130006‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:ORTHOVERSEIAIntegratedProcessor(VIP)ClearedDate:23‐MAY‐2013BK130032‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:ORTHO(TM)WorkstationClearedDate:09‐AUG‐2013BK140207‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:ORTHOVISIONAnalyzerClearedDate:14‐AUG‐2015BK160058‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:ORTHOVISIONMaxAnalyzerClearedDate:21‐OCT‐2016BK190338‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:ORTHOVISIONAnalyzerClearedDate:09‐JUL‐2019BK190399‐0Ortho‐ClinicalDiagnostics,Inc.
1001U.
S.
Highway202Raritan,NJ08869‐0606TradeName:ORTHOVISIONMaxAnalyzerClearedDate:17‐DEC‐2019BK040017‐0OrthogenTherapeutics,GmbHGraf‐Adolf‐Str.
43D‐40210Dusseldorf,GERMANYTradeName:OsteokinSystemClearedDate:23‐JUN‐2004BK080014‐0PallCorporation25HarborParkDrivePortWashington,NY11050‐4630TradeName:PalleBDSClearedDate:13‐FEB‐2009ClearedUnderPallLifeSciencesBK150314‐0PallCorporation25HarborParkDrivePortWashington,NY11050‐4630TradeName:PallBriostorTransfer/FreezingBagSetClearedDate:16‐JUN‐2016BK120029‐0PatientSafeSolutions5375MiraSorrentoPlaceSuite500SanDiego,CA92121TradeName:PatientTouch(TM)BloodProductAdministrationSystemv3.
2.
1ClearedDate:13‐NOV‐2012BK820002‐0Pel‐FreezClinicalSystems,LLCPOBox68Rogers,AR72756TradeName:NotavailablefromBLTmigrateddata.
ClearedDate:06‐OCT‐1982BK820023‐0Pel‐FreezClinicalSystems,LLCPOBox68Rogers,AR72756TradeName:LeukocyteTypingSerum(Human)(TrayPackage)ClearedDate:12‐JAN‐1983BK850004‐0Pel‐FreezClinicalSystems,LLC9099N.
DeerbrookTrailBrownDeer,WI53223TradeName:FrozenLeukocytePanel(Human)ClearedDate:01‐AUG‐1985BK000019‐0Pel‐FreezClinicalSystems,LLC9099N.
DeerbrookTrailBrownDeer,WI53223TradeName:UniTraySSPHLATypingKitsClearedDate:29‐JAN‐2001BK020068‐0Pel‐FreezClinicalSystems,LLC9099N.
DeerbrookTrailBrownDeer,WI53223TradeName:PelFreezHLAHighResolutionSSPUniTrayClearedDate:14‐JAN‐2003BK030003‐0Pel‐FreezClinicalSystems,LLC9099N.
DeerbrookTrailBrownDeer,WI53223TradeName:UniMatchPlusClearedDate:25‐FEB‐2003BK050055‐0PerfusionPartners&Associates,Inc.
6227FoxfireLaneFortMyers,FL33912TradeName:GenesisCSComponentConcentratingSystemClearedDate:13‐OCT‐2006BK900018‐0PolarProducts,Inc.
2808OregonCt.
BldgK‐4Torrance,CA90503TradeName:PolarProducts'ModelMTE‐58LClearedDate:30‐AUG‐1990BK060056‐0PrescottIdeasLLC8960E.
AnnaPlaceTucson,AZ85710TradeName:AntibodyCheck‐4.
1ClearedDate:23‐APR‐2007BK140119‐0ProFibrixBVDarwinweg24Leiden,NETHERLANDSTradeName:RaplixaSprayDeviceClearedDate:30‐APR‐2015BK170092‐0ProgenikaBiopharma,S.
A.
Ibaizabalbidea,Edificio504ParqueTechnologicodeBizkaiaDerio,Bizkaia,TradeName:IDCORECONTROLClearedDate:11‐OCT‐2018BK010017‐0PsycheSystemsCorpTenLaurelAvenueWellesley,MA02481TradeName:SystemBloodBank(SBB)Software‐3.
0ClearedDate:04‐SEP‐2001BK180188‐0PuriBloodMedicalCo.
Ltd.
2F.
,No.
11,GongyeE.
9thRd.
PaoshanHsiang,HsinchuHsienTAIWAN30075TradeName:LeukocyteReductionFilterforRedBloodCellsLeukocytereductionfilterforredbloodcellsClearedDate:23‐NOV‐2018BK840020‐0QueueSystems22AirportIndustrialParkRd.
,Box1901Parkersburg,WV26102TradeName:CryostarClearedDate:23‐OCT‐1984BK990005‐0R&DSystems,Inc614McKinleyPlaceN.
E.
Minneapolis,MN55413TradeName:StatusFlowProClearedDate:21‐JUN‐1999BK000035‐0R&DSystems,Inc614McKinleyPlaceN.
E.
Minneapolis,MN55413TradeName:R&DLeuko‐ReducedRBCControlClearedDate:13‐DEC‐2000BK000036‐0R&DSystems,Inc614McKinleyPlaceN.
E.
Minneapolis,MN55413TradeName:R&DLeuko‐ReducedPltControlClearedDate:13‐DEC‐2000BK040012‐0R&DSystems,Inc614McKinleyPlaceN.
E.
Minneapolis,MN55413TradeName:R&DDonorCheckerHematologyControlClearedDate:05‐MAR‐2004BK040063‐0R&DSystems,Inc614McKinleyPlaceN.
E.
Minneapolis,MN55413TradeName:R&DPlasmaHemoglobinHematologyControlClearedDate:17‐SEP‐2004BK910012‐0ROCHEBIOMEDICALLABORATORIES,INC.
112ORANGEDRIVEELONCOLLEGE,NC27244TradeName:HLACLASSIPHENOTYPINGTRAYSClearedDate:06‐JAN‐1992BK200543‐0RanfacCorporation30DohertyStAvon,MA02322TradeName:RanfacAutologousPlateletSeperatorClearedDate:24‐FEB‐2021BK860034‐0ReagentLaboratory,Inc.
300EastOttawaAvenueLouisville,KY40209TradeName:SodiumChloride1.
3%ClearedDate:01‐JUN‐1987BK140211‐0ReapplixApsBlokken45Birkerod,DENMARKTradeName:3CPatchSystemClearedDate:24‐FEB‐2016BK170002‐0ReapplixApsBlokken45Birkerod,DENMARKTradeName:3CPatchSystemClearedDate:04‐APR‐2017BK200471‐0ReapplixApsBlokken45Birkerod,DENMARKTradeName:3CPatchSystemClearedDate:13‐JAN‐2021BK170095‐0RedDressLtdShkedimStreet11PardesHanna,ISRAEL370110BK190349‐0BK200464‐0BK090048‐0BK110061‐0BK120057‐0BK120066‐0BK170128‐0TradeName:RD1SystemClearedDate:14‐JUN‐2018RedDressLtdShkedimStreet11PardesHanna,ISRAEL370110TradeName:RD2SystemClearedDate:08‐NOV‐2019RedDressLtdShkedimStreet11PardesHanna,ISRAEL370110TradeName:RD2SystemClearedDate:20‐MAR‐2020RegenLabSA3428AvenueMarcilMontreal,QuebecCANADAH4A2Z3TradeName:RegenKit‐THTClearedDate:18‐MAY‐2010ClearedUnderRegenLabSARLRegenLabSAEnBudronB2CH‐1052LeMontsurLausanne,SWITZERLANDTradeName:RegenKit‐BCTFamilyKitsClearedDate:08‐MAY‐2012ClearedUnderRegenLabSARLRegenLabSA3428AvenueMarcilMontreal,QuebecCANADAH4A2Z3TradeName:A‐CP‐KitFamilyKitsClearedDate:08‐AUG‐2013RegenLabSA3428AvenueMarcilMontreal,QuebecCANADAH4A2Z3TradeName:RegenKit‐ATS‐3RegenKit‐BCT‐1PlusRegenKit‐BCT‐2PlusClearedDate:05‐FEB‐2014ReichertInc.
3362WaldenAveSuite100Depew,NY14043TradeName:TSMeter‐DSPClearedDate:19‐DEC‐2017BK880029‐0Revco/Lindberg275AikenRoadAsheville,NC28804TradeName:MBF700BloodFreezerClearedDate:16‐JUN‐1989BK890023‐0Revco/Lindberg275AikenRoadAsheville,NC28804TradeName:HLT‐20DR‐87BloodFreezerClearedDate:21‐SEP‐1990BK890025‐0Revco/Lindberg275AikenRoadAsheville,NC28804TradeName:HLT‐50V‐4BBBloodRefrigeratorClearedDate:02‐FEB‐1990BK890026‐0Revco/Lindberg275AikenRoadAsheville,NC28804TradeName:REB3704BloodRefrigeratorClearedDate:02‐FEB‐1990BK950054‐0Revco/Lindberg275AikenRoadAsheville,NC28804TradeName:BloodStorageRefrigeratorREB2304ClearedDate:11‐JAN‐1996BK950066‐0Revco/Lindberg275AikenRoadAsheville,NC28804TradeName:RevcoHLT30V‐4BBClearedDate:31‐JAN‐1996BK890006‐0Rexco275AikenAsheville,NC28804TradeName:MBF500BloodFreezerClearedDate:16‐JUN‐1989BK020018‐0RocheMolecularSystems,Inc.
4300HaciendaDriveP.
O.
Box9002Pleasanton,,CA94588‐0900TradeName:CobasAmpliscreenSystemClearedDate:26‐NOV‐2002BK020025‐0RocheMolecularSystems,Inc.
4300HaciendaDriveP.
O.
Box9002Pleasanton,,CA94588‐0900TradeName:COBASAmpliScreenDataOutputManagementSystem(DOMS)‐1.
00.
04ClearedDate:10‐DEC‐2002BK140195‐0RocheMolecularSystems,Inc.
4300HaciendaDriveP.
O.
Box9002Pleasanton,,CA94588‐0900TradeName:Cobasp680InstrumentCobas8800SystemClearedDate:20‐OCT‐2016BK140196‐0RocheMolecularSystems,Inc.
4300HaciendaDriveP.
O.
Box9002Pleasanton,,CA94588‐0900TradeName:cobasp680Instrumentcobas6800SystemClearedDate:20‐OCT‐2016BK110045‐0RownySystems,Inc.
7555SpringLakeDriveBethesda,MD20817‐6507TradeName:AntigenPLUS‐7.
4ClearedDate:25‐MAY‐2012BK180204‐0RoyalBiologicsLLC190ColumbusDriveSuite#2AJerseyCity,NJ07302TradeName:RoyalMaxxPRPConcentrationSystemClearedDate:12‐JUL‐2018BK990008‐0Rubin&Poor,Inc.
155MaplewoodAvenue#5Maplewood,NJ07040TradeName:Rubin&PoorConfigurableManualBlotSystem‐1.
0CClearedDate:29‐OCT‐1999BK000030‐0Rubin&Poor,Inc.
155MaplewoodAvenue#5Maplewood,NJ07040TradeName:ConfigurableLaboratoryResultManager(CLRM)‐1.
0EClearedDate:23‐NOV‐2001BK030073‐0Rubin&Poor,Inc.
155MaplewoodAvenue#5Maplewood,NJ07040TradeName:ConfigurableManualBatchEntry‐1.
1AClearedDate:14‐JAN‐2004BK080028‐0Rubin&Poor,Inc.
155MaplewoodAvenue#5Maplewood,NJ07040TradeName:PoolresultsManagerClearedDate:03‐SEP‐2008BK050045‐0SCCSoftComputer34350U.
S.
Highway19NorthPalmHarbor,FL34684TradeName:SoftDonor4.
3withSoftScapeClearedDate:26‐OCT‐2005BK060059‐0SCCSoftComputer34350U.
S.
Highway19NorthPalmHarbor,FL34684TradeName:SoftDonor4.
4withDMSI‐4.
4ClearedDate:21‐DEC‐2006BK080020‐0SCCSoftComputer5400TechDataDriveClearwater,FL33760TradeName:SoftBankII‐v23.
2ClearedDate:12‐AUG‐2008BK080069‐0SCCSoftComputer5400TechDataDriveClearwater,FL33760TradeName:SoftDonor4.
5‐4.
5ClearedDate:16‐JAN‐2009BK090017‐0SCCSoftComputer5400TechDataDriveClearwater,FL33760TradeName:SoftBankIIVersion25‐25ClearedDate:23‐JUN‐2009BK090078‐0SCCSoftComputer5400TechDataDriveClearwater,FL33760TradeName:SoftID.
TxVersion1.
0ClearedDate:28‐APR‐2010BK100045‐0SCCSoftComputer5400TechDataDriveClearwater,FL33760TradeName:SoftBankII‐25.
1ClearedDate:29‐JUL‐2010BK140128‐0SCCSoftComputer5400TechDataDriveClearwater,FL33760TradeName:SoftBankVersion25.
5ClearedDate:05‐AUG‐2014BK200531‐0SCCSoftComputer5400TechDataDriveClearwater,FL33760TradeName:SoftBank‐25.
6.
1.
0SoftBank.
web‐25.
6.
1.
0ClearedDate:18‐DEC‐2020BK950057‐0SGScientific5745SW75thStreet#284Gainseville,FL32608TradeName:TheSaber(SegmentPiercingDevice)ClearedDate:13‐NOV‐1995BK090047‐0SPINESMITHPARTNERSLP93RedRiverAustin,TX78701TradeName:FusionaryGraftDeliverySystemClearedDate:10‐FEB‐2010BK050052‐0STEMCOBiomedical,Inc.
2810MeridanParkwaySuite148Durham,NC27713TradeName:AldecountProgenitorCellEnumerationKitClearedDate:02‐DEC‐2005BK130052‐0STRATECBiomedicalUKLimited1BarberryCourt,CallisterWayBurtonuponTrent,TradeName:ProcleixNATManagerSoftware(Version1.
1)ClearedDate:17‐APR‐2014BK160071‐0STRATECBiomedicalUKLimitedThirdAve,Centrum100BurtonuponTrentStraffordshire,DE142WDUNITEDKINGDOMTradeName:AuroraEnterprise‐Cat.
No.
AUR‐ENT‐001ClearedDate:30‐OCT‐2017BK160113‐0STRATECBiomedicalUKLimited98MainStreetSuite205Southington,CT06489TradeName:cobasSynergySoftware(Version1.
0)ClearedDate:19‐APR‐2017BK160124‐0STRATECBiomedicalUKLimitedThirdAve,Centrum100BurtonuponTrentStraffordshire,DE142WDUNITEDKINGDOMTradeName:ORTHOCONNECTClearedDate:17‐OCT‐2017BK160125‐0STRATECBiomedicalUKLimitedThirdAve,Centrum100BurtonuponTrentStraffordshire,DE142WDUNITEDKINGDOMTradeName:ProcleixNATManagerv1.
2Software‐v1.
2ClearedDate:25‐APR‐2017BK190434‐0STRATECBiomedicalUKLimitedThirdAve,Centrum100BurtonuponTrentStraffordshire,DE142WDUNITEDKINGDOMTradeName:ORTHOCONNECT‐3.
0OrthoConnect‐3.
0ClearedDate:10‐MAR‐2020BK940017‐0SangStatMedicalCorporation6300DumbartonCircleFreemont,CA94555TradeName:PRA‐STATElisa/PanelReactAnti‐HLAClassIIgGAntibodyClearedDate:27‐SEP‐1994BK950009‐0SangStatMedicalCorporation6300DumbartonCircleFreemont,CA94555TradeName:CROSSSTATClearedDate:09‐MAY‐1995BK970019‐0SangStatMedicalCorporation6300DumbartonCircleFreemont,CA94555ClearedDate:30‐JUL‐1997BK970037‐0SangStatMedicalCorporation6300DumbartonCircleFreemont,CA94555TradeName:PRA‐STATAnti‐HLACLASSIIgGAntibodies/TwoPatientsperPlateFormatClearedDate:18‐NOV‐1998BK940011‐0SanguinInternational1020ShermanAvenueHamden,CT06514TradeName:SanguinMedusa2000ClearedDate:29‐SEP‐1994BK960065‐0SanguinInternational1020ShermanAvenueHamden,CT06514TradeName:SanguinMedusa2000‐3.
4ClearedDate:17‐DEC‐1998BK980003‐0SanguinInternational1020ShermanAvenueHamden,CT06514TradeName:Aurora/Fenestra(version1.
0)ClearedDate:29‐SEP‐1999BK980039‐0SanguinInternational1020ShermanAvenueHamden,CT06514TradeName:Medusa2000Srimport,Version1.
2ClearedDate:11‐JUN‐1999BK090061‐0SanguinInternational1020ShermanAvenueHamden,CT06514TradeName:SanguinAuroraversion2.
0ClearedDate:22‐DEC‐2009BK100030‐0SanguinInternational1020ShermanAvenueHamden,CT06514TradeName:SanguinLibertySRIMPORT‐3.
1ClearedDate:08‐JUL‐2010BK010042‐0Sarstedt,Inc.
1025SaintJamesChurchRd.
Newton,NC20865TradeName:TranswaagKLClearedDate:12‐DEC‐2001BK010045‐0Sarstedt,Inc.
1025SaintJamesChurchRd.
Newton,NC20865TradeName:SaharaBlood&PlasmaWarmingDeviceClearedDate:21‐DEC‐2001BK030006‐0Sarstedt,Inc.
1025SaintJamesChurchRd.
Newton,NC20865TradeName:TranswaagDisk01ClearedDate:27‐FEB‐2003BK040080‐0Sarstedt,Inc.
1025SaintJamesChurchRd.
Newton,NC20865TradeName:Sahara‐TSCClearedDate:09‐FEB‐2005BK070029‐0Sarstedt,Inc.
1025SaintJamesChurchRd.
Newton,NC20865TradeName:S‐MonovetteACD‐AClearedDate:21‐SEP‐2007BK870028‐0SaturnBioTechCorporationP.
O.
Box3823Littleton,CO80161TradeName:RMEDFingerHemeTrapClearedDate:01‐FEB‐1988BK940029‐0ScimedLifeSystems,Inc.
6655WedgewoodRd.
MapleGrove,MN55311TradeName:SCIMEDUltraFuseCoron.
Infusion/GuidewireExchangeCatheterClearedDate:15‐MAR‐1995BK870011‐0SeabrookMedicalSystems,Inc.
673WilmerAveuneCincinnati,OH45226TradeName:ECMO‐TEMPClearedDate:14‐SEP‐1987BK820005‐0SeparationScienceCorporation169AvonStreet,P.
O.
Box643Stratford,CT06497TradeName:SEPCORCellLineMonitorClearedDate:06‐JUL‐1982BK880005‐0SeparationScienceCorporation169AvonStreet,P.
O.
Box643Stratford,CT06497TradeName:BloodBankSaline,PreservedClearedDate:09‐JUN‐1988BK050056‐0SeparationTechnology,Inc.
1096RainierDriveAltamonteSprings,FL32714‐3855TradeName:UltraChekReferenceControls‐ProductCodeGLKUltraCritTMHematocritMeasurementDevice‐ProductCodeGKFClearedDate:12‐DEC‐2005BK960036‐0SharedMedicalSystems51ValleyStreamParkwayMalvern,PA19355TradeName:SMSBBTransfusionSystemClearedDate:12‐DEC‐1997BK990018‐0Shotwell&Carr,Inc.
3535FirewheelDriveSuiteAFlowerMound,TX75028‐2628TradeName:HotShotFluidWarmerModel100HotShotFluidWarmerModel101HotShotFluidWarmerModel102HotShotFluidWarmerModel103ClearedDate:13‐OCT‐1999BK090077‐0SiemensHealthcareDiagnostics,Inc.
P.
O.
Box2466Berkeley,CA94702TradeName:TRUGENEHIV‐1GenotypingKitandOpenGeneDNASequencingSystemClearedDate:28‐DEC‐2009ClearedUnderSiemensHealthcareDiagnosticsInc.
BK110007‐0SiemensHealthcareDiagnostics,Inc.
P.
O.
Box2466Berkeley,CA94702TradeName:TRUGENEHIV‐1GenotypingKitandOpenGeneDNASequencingSystemClearedDate:04‐MAR‐2011ClearedUnderSiemensHealthcareDiagnosticsInc.
BK120013‐0SiemensHealthcareDiagnostics,Inc.
P.
O.
Box2466Berkeley,CA94702TradeName:TRUGENEHIV‐1GenotypingKitandOpenGeneDNASequencingSystemClearedDate:27‐MAR‐2012ClearedUnderSiemensHealthcareDiagnosticsInc.
BK140152‐0SiemensHealthcareDiagnostics,Inc.
511BenedictAveTarrytown,NY10591TradeName:ADVIACentaurSystem(SoftwareVersion4.
0withSP4ClearedDate:08‐JUN‐2015BK140153‐0SiemensHealthcareDiagnostics,Inc.
511BenedictAveTarrytown,NY10591TradeName:ADVIACentaurXPSystem(SWv7.
1)ClearedDate:08‐JUN‐2015BK960051‐0SiemensMedicalSolutionsDiagnostics800DwightWayBerkeley,CA94701‐1986TradeName:PPIS‐Version2.
0ClearedDate:07‐AUG‐1998ClearedUnderBayerCorporationBK990024‐0SiemensMedicalSolutionsDiagnostics800DwightWayBerkeley,CA94701‐1986TradeName:PlasmaProcurementInformationSystem(PPIS)‐3.
0ClearedDate:03‐NOV‐1999ClearedUnderBayerCorporationBK990037‐0SiemensMedicalSolutionsDiagnostics800DwightWayBerkeley,CA94701‐1986TradeName:PlasmaProcurementInformationSystem(PPIS)‐Version4.
0ClearedDate:17‐NOV‐1999ClearedUnderBayerCorporationBK060015‐0SiemensMedicalSolutionsDiagnosticsP.
O.
Box2466Berkeley,CA94702‐0466TradeName:TRUGENEHIV‐1GenotypingKitandOpenGeneDNASequencingSystemClearedDate:21‐MAR‐2006ClearedUnderBayerHealthCareDiagnosticsDivisionBK070009‐0SiemensMedicalSolutionsDiagnosticsP.
O.
Box2466Berkeley,CA94702‐0466TradeName:TRUGENEHIV‐1GenotypingKitandOpenGeneDNASequencingSystemClearedDate:19‐MAR‐2007BK080036‐0SiemensMedicalSolutionsDiagnosticsP.
O.
Box2466Berkeley,CA94702‐0466TradeName:TRUGENEHIV‐1GenotypingKitandOpenGeneDNASequencingSystemClearedDate:20‐OCT‐2008BK080073‐0SiemensMedicalSolutionsDiagnosticsP.
O.
Box2466Berkeley,CA94702‐0466TradeName:TRUGENEHIV‐1GenotypingKitandOpenGeneDNASequencingSystemClearedDate:15‐JAN‐2009BK060004‐0Smith&Nephew1450BrooksRoadMemphis,TN38116TradeName:PromotePlateletRichConcentrate(PRC)PreparationSystemClearedDate:02‐MAY‐2006BK850011‐0SmithklineBeckmanCorp.
999WestValleyRoadWayne,PA19087TradeName:Accugenics(Tray)ClearedDate:07‐AUG‐1985BK850012‐0SmithklineBeckmanCorp.
999WestValleyRoadWayne,PA19087TradeName:Accugenics(HLAControlCells)ClearedDate:07‐AUG‐1985BK080047‐0SofTovLtd32HaShachamStreetPetachTikva,ISRAEL49170TradeName:AutoFusion‐v3.
02ClearedDate:05‐JUN‐2009BK960033‐0SoftComputerConsultantsInc.
34350U.
S.
HWY19N.
PalmHarbor,FL34684TradeName:SoftBankIIVersion19.
1ClearedDate:10‐JUL‐1998BK000040‐0SoftComputerConsultantsInc.
34350U.
S.
HWY19N.
PalmHarbor,FL34684TradeName:SoftBankII‐21.
2ClearedDate:20‐APR‐2001BK020006‐0SoftComputerConsultantsInc.
34350U.
S.
HWY19N.
PalmHarbor,FL34684TradeName:SoftDonor‐4.
1ClearedDate:27‐FEB‐2003BK020021‐0SoftComputerConsultantsInc.
34350U.
S.
HWY19N.
PalmHarbor,FL34684TradeName:SoftBankII‐22ClearedDate:11‐SEP‐2002BK030018‐0SoftComputerConsultantsInc.
34350U.
S.
HWY19N.
PalmHarbor,FL34684TradeName:SoftBankII‐23ClearedDate:17‐APR‐2003BK040028‐0SoftComputerConsultantsInc.
34350U.
S.
HWY19N.
PalmHarbor,FL34684TradeName:SoftBankIIwithSoftScape‐23ClearedDate:07‐MAY‐2004BK040048‐0SoftComputerConsultantsInc.
34350U.
S.
HWY19N.
PalmHarbor,FL34684TradeName:SoftBankIIwithDatabaseManagementSystemInterface(DMSI)‐v23.
1ClearedDate:23‐AUG‐2004BK970032‐0Sorvall,Inc.
31PecksLaneNewtown,CT06470TradeName:RC12BPClearedDate:05‐DEC‐1997BK030064‐0StemcoBiomedical,Incorporated2810MeridianParkwaySuite148Durham,NC27713TradeName:AldecountProgenitorCellEnumerationKitClearedDate:31‐DEC‐2003BK040075‐0StemcoBiomedical,Incorporated2810MeridianParkwaySuite148Durham,NC27713TradeName:AldecountProgenitorCellEnumerationKitClearedDate:06‐JAN‐2005BK860030‐0StephensScientific7AstroPlaceBox1116Denville,NJ07834TradeName:StephensScientificCertifiedBloodBankSalineClearedDate:16‐DEC‐1986BK870015‐0StephensScientific7AstroPlaceBox1116Denville,NJ07834TradeName:CertifiedBloodBankSaline,PreservedClearedDate:02‐NOV‐1987BK870016‐0StephensScientific7AstroPlaceBox1116Denville,NJ07834TradeName:CertifiedSaline,PreservedClearedDate:02‐NOV‐1987BK880013‐0StericonInc.
2315GardnerRoad.
Broadview,IL60153TradeName:RCM‐10PediatricSizedFreezingBagClearedDate:09‐NOV‐1988BK920022‐0StericonInc.
2315GardnerRoad.
Broadview,IL60153TradeName:MB‐30EmptyPlasticContainersClearedDate:03‐JUN‐1993BK200477‐0SunevaMedical,Inc.
5870PacificCenterBlvdSanDiego,CA92121TradeName:AmplifineGelSeparatorTubesSunevaHDPRPPlateletPreparationSystemClearedDate:30‐SEP‐2020BK990002‐0SunquestInformationSystems,Inc.
4801BroadwayBoulevardTucson,AZ85711TradeName:Flexilab‐5.
2ClearedDate:16‐AUG‐1999BK990034‐0SunquestInformationSystems,Inc.
4801BroadwayBoulevardTucson,AZ85711TradeName:FlexiLabBloodBankandBloodDonorSystem‐Version5.
2ClearedDate:17‐NOV‐1999BK080021‐0SunquestInformationSystems,Inc.
250S.
WilliamsBlvd.
Tucson,AZ85711TradeName:SunquestTransfusionManager‐v1.
0ClearedDate:14‐SEP‐2017BK080042‐0SunquestInformationSystems,Inc.
250S.
WilliamsBlvd.
Tucson,AZ85711TradeName:SunquestBloodBankDonor‐6.
4ClearedDate:03‐MAR‐2009BK140124‐0SunquestInformationSystems,Inc.
250S.
WilliamsBlvd.
Tucson,AZ85711TradeName:SunquestTransfusionManagerversion2.
0ClearedDate:18‐JUN‐2014BK160005‐0SunquestInformationSystems,Inc.
250S.
WilliamsBlvd.
Tucson,AZ85711TradeName:SunquestBloodBankandBloodDonor‐Version8.
0ClearedDate:25‐MAR‐2016BK120061‐0SynGen,Inc212519thStreet,Suite120Sacramento,CA95818TradeName:SynGenX‐1000ClearedDate:12‐JUL‐2013BK120067‐0SysLogic,Inc.
375BishopsWay,Suite105Brookfield,WI53005TradeName:iTraceforBloodCenters‐1.
0.
924.
0ClearedDate:14‐SEP‐2017BK960034‐0SysTecComputerAssociates,Inc.
738SmithtownBypassSmithtown,NY11787TradeName:LifetecComm.
BloodCenterSystem‐Rev2.
10ClearedDate:28‐JUL‐1998BK990003‐0SysTecComputerAssociates,Inc.
28NorthCountryRoadMt.
Sinai,NY11766TradeName:LifeTec‐2.
20ClearedDate:30‐JUL‐1999BK040026‐0SysTecComputerAssociates,Inc.
28NorthCountryRoadMt.
Sinai,NY11766TradeName:LifeTecDonorVerificationandCollectionSystem(DOVAC)‐1.
00ClearedDate:21‐OCT‐2004BK060032‐0SysTecComputerAssociates,Inc.
28NorthCountryRoadMt.
Sinai,NY11766TradeName:LifeTecElite‐1.
0ClearedDate:15‐AUG‐2006BK080067‐0SysmexAmerica,Inc.
OneNelsonC.
WhiteParkwayMundelein,IL60060TradeName:SysmexXE‐2100DandXS‐1000iClearedDate:08‐SEP‐2009BK120076‐0TERUMOBCT10811W.
CollinsAveLakewood,CO80215‐4440TradeName:SpectraOptiaApheresisSystemClearedDate:25‐FEB‐2013BK130031‐0TERUMOBCT10811W.
CollinsAveLakewood,CO80215‐4440TradeName:SpectraOptiaApheresisSystemClearedDate:25‐JUL‐2013BK130065‐0TERUMOBCT10811W.
CollinsAveLakewood,CO80215‐4440TradeName:SpectraOptiaApheresisSystemClearedDate:16‐JAN‐2014BK130080‐0TERUMOBCT10811W.
CollinsAveLakewood,CO80215‐4440TradeName:TrimaAccelSystem,Version6.
2ClearedDate:19‐MAR‐2014BK140151‐0TERUMOBCT10811W.
CollinsAveLakewood,CO80215‐4440TradeName:SpectraOptiaApheresisSystemClearedDate:13‐AUG‐2014BK150251‐0TERUMOBCT10811W.
CollinsAveLakewood,CO80215‐4440TradeName:SpectraOptiaApheresisSystemClearedDate:16‐JUL‐2015BK160116‐0TERUMOBCT10811W.
CollinsAveLakewood,CO80215‐4440TradeName:TrimaAccelAutomatedBloodCollectionSystemClearedDate:23‐DEC‐2016BK120012‐0TERUMOCorporation10811W.
CollinsAvenueLakewood,CO80215TradeName:SpectraOptiaApheresisSystemClearedDate:09‐JUL‐2012BK120017‐0TERUMOCorporation10811W.
CollinsAvenueLakewood,CO80215TradeName:TrimaAccelAutomatedBloodComponentCollectionSystemClearedDate:31‐MAY‐2012BK120040‐0TERUMOCorporation10811W.
CollinsAvenueLakewood,CO80215TradeName:TrimaAccelSystemClearedDate:03‐OCT‐2012BK120049‐0TERUMOCorporation10811W.
CollinsAvenueLakewood,CO80215TradeName:TrimaAccelSystemClearedDate:17‐DEC‐2012BK970012‐0TahoeChemicalR&D2230DamonRoadCarsonCity,NV89701TradeName:NoverTripScaleAlarmClearedDate:14‐JUL‐1997BK040062‐0TalismanLtd.
421ChurchStreetNE.
SuiteFVienna,VA22180TradeName:QualityDonorSystem2004‐2.
0ClearedDate:18‐OCT‐2004BK060031‐0TalismanLtd.
421ChurchStreetNE.
SuiteFVienna,VA22180TradeName:TalismanPhlebotomySystemRelease1.
0ClearedDate:27‐JUL‐2006BK070020‐0TalismanLtd.
421ChurchStreetNE.
SuiteFVienna,VA22180TradeName:QualityDonorSystem‐v2.
1ClearedDate:16‐JUL‐2007BK980021‐0TalonMedical,Ltd.
18160Highway281NSuite108SanAntonio,TX78232TradeName:Cord‐XSystemClearedDate:20‐JAN‐1999BK050003‐0TepnelLifecodesCorporation550WestAvenueStamford,CT06902TradeName:LIFECODESHLA‐ATypingKitforusewithLuminex100,LIFECODESHLA‐BTypingKitforusewithLuminex100,HLA‐CTypingKitforusewithLuminex100LIFECODESHLA‐DQBTypingKitforusewithLuminex100andLIFECODESHLA‐DRBTypingKitforusewithLuminex100ClearedDate:18‐JUL‐2005BK080050‐0TepnelLifecodesCorporation550WestAvenueStamford,CT06902TradeName:LIFECODESHLATypingKits(HLA‐A,B,C,DQB,DRB,DRB1)forusewithLuminexClearedDate:13‐NOV‐2008BK090018‐0TepnelLifecodesCorporation550WestAvenueStamford,CT06902TradeName:LIFECODESEvolutionSoftware,version1.
0ClearedDate:04‐JUN‐2009BK010006‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:TrimaAutomatedBloodComponentCollectionSystemClearedDate:27‐FEB‐2002ClearedUnderGambroBCT,IncBK010037‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:PlateletcollectionsetsfortheCOBESpectraApheresisSystemandtheTrimaAutomatedBloodComponentCollectionSystem.
ClearedDate:24‐SEP‐2003ClearedUnderGambroBCT,IncBK010046‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:TrimaAutomatedBloodCollectionSystem(SingleStage)ClearedDate:18‐SEP‐2002ClearedUnderGambroBCT,IncBK010050‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:TrimaAutomatedBloodCollectionSystemClearedDate:18‐SEP‐2002ClearedUnderGambroBCT,IncBK020015‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:VistaInformationSystem,IndependentSolutionClearedDate:15‐JUL‐2002ClearedUnderGambroBCT,IncBK020041‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:COBESpectraApheresisSystem/BloodcomponentdisposablecollectionsetsforapheresisClearedDate:23‐APR‐2003ClearedUnderGambroBCT,IncBK030021‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:VistaInformationSystem‐2.
1ClearedDate:01‐MAY‐2003ClearedUnderGambroBCT,IncBK030083‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:TrimaAccelClearedDate:14‐JAN‐2004ClearedUnderGambroBCT,IncBK040069‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:TrimaAutomatedBloodComponentCollectionSystem‐BloodComponentSamplingAccessoryClearedDate:28‐OCT‐2004ClearedUnderGambroBCT,IncBK040086‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:COBESpectraApheresisSystem&TrimaAutomatedBloodComponentCollectionSystemClearedDate:15‐MAR‐2005ClearedUnderGambroBCT,IncBK070001‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:VistaInformationSystem‐3.
0ClearedDate:27‐JUN‐2007ClearedUnderGambroBCT,IncBK070066‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:VistaInformationSystem,Version3.
0withMedicalReviewModuleClearedDate:13‐DEC‐2007ClearedUnderGambroBCT,IncBK080010‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:TheAtreusWholeBloodProcessingSystemClearedDate:27‐JUN‐2008ClearedUnderGambroBCT,IncBK080029‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:TrimaAccelAutomatedBloodComponentCollectionSystemClearedDate:18‐MAY‐2010ClearedUnderGambroBCT,IncBK140104‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:VistaInformationSystemVersion3.
2ClearedDate:01‐APR‐2014BK140158‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:TrimaAccelSystemVersion6.
4ClearedDate:29‐AUG‐2014BK140180‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:Model81000TrimaAccelSystemMobileProPackageClearedDate:05‐NOV‐2014BK140191‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:SpectraOptiaApheresisSystemClearedDate:09‐MAR‐2015BK150228‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:VistaInformationSystem‐4.
0ClearedDate:22‐SEP‐2015BK150269‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:TrimaAccelsystemClearedDate:06‐AUG‐2015BK150321‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:TrimaAccelSystemClearedDate:16‐OCT‐2015BK160082‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:T‐CuffClearedDate:19‐AUG‐2016BK160108‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:TSCD‐IISterileTubingWelderwithorwithoutTruciseTotalSystem(TM),ModelME‐SC203AClearedDate:23‐NOV‐2016BK170059‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:TrimaAccel(R)BloodCollectionSystemClearedDate:07‐JUL‐2017BK170098‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215‐4498TradeName:TSCD‐IISterileTubingWelderwithorwithoutTruciseTotalSystem(TM)ClearedDate:29‐SEP‐2017BK170157‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215TradeName:TrimaAccel(R)BloodCollectionSystemClearedDate:06‐APR‐2018BK180231‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215TradeName:TrimaAccel(R)BloodCollectionSystemTrimaAccelAutomatedBloodCollectionSystemClearedDate:17‐AUG‐2018BK180258‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215TradeName:VistaInformationSystemClearedDate:18‐JAN‐2019BK190332‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215TradeName:TrimaAccelBloodCollectionSystemClearedDate:22‐MAY‐2019BK190333‐0TerumoBCT,Inc10811W.
CollinsAve.
Lakewood,CO80215TradeName:TOMEs‐7ClearedDate:03‐DEC‐2019BK820015‐0TerumoCorporation2805EastAnaStreetCompton,CA90221TradeName:PlasmaflexPoolingBottleClearedDate:12‐NOV‐1982BK850017‐0TerumoCorporation2805EastAnaStreetCompton,CA90221TradeName:PlasmaflexBottlesClearedDate:04‐NOV‐1985BK860012‐0TerumoCorporation2805EastAnaStreetCompton,CA90221TradeName:ImugardLeukocyteFilterClearedDate:16‐MAY‐1990BK890005‐0TerumoCorporation2805EastAnaStreetCompton,CA90221TradeName:StericellCellProcessorClearedDate:10‐OCT‐1989BK890017‐0TerumoCorporation2805EastAnaStreetCompton,CA90221TradeName:TeruflexTransferBagClearedDate:18‐JUL‐1990BK890032‐0TerumoCorporation125BlueBallRoadElkton,MD21921TradeName:Immugard‐E‐LeukocyteRemovalFromRedBloodCellsClearedDate:18‐JUL‐1990BK900028‐0TerumoCorporation2805EastAnaStreetCompton,CA90221TradeName:TerufusionPlasmaTransferSetClearedDate:22‐OCT‐1990BK920040‐0TerumoCorporation2805EastAnaStreetCompton,CA90221TradeName:VenojectIIHolderClearedDate:20‐MAY‐1993BK950039‐0TerumoCorporation2100CottontailLaneSomerset,NJ08873TradeName:TeruflexB‐600TerumoBloodBagwithoutanticoagulantClearedDate:25‐AUG‐1995BK950058‐0TerumoCorporation2100CottontailLaneSomerset,NJ08873TradeName:TerumoSamplingSiteCouplerClearedDate:13‐NOV‐1995BK860041‐0TerumoMedicalCorporation125BlueBallRoadElkton,MD21921TradeName:SCD312ClearedDate:01‐JUN‐1987BK970008‐0TerumoMedicalCorporation125BlueBallRoadElkton,MD21921TradeName:TerumoSterileTubingWelderSC‐201A(TSCD)ClearedDate:28‐MAY‐1998BK970011‐0TerumoMedicalCorporation125BlueBallRoadElkton,MD21921TradeName:TerumoPhlebotomyNeedleCapHolderClearedDate:19‐JUN‐1997BK000045‐0TerumoMedicalCorporation125BlueBallRoadElkton,MD21921TradeName:ImugardIII‐PLClearedDate:28‐SEP‐2001BK020033‐0TerumoMedicalCorporation125BlueBallRoadElkton,MD21921TradeName:ImugardIII‐PLLeukocytereductionfilterClearedDate:22‐MAY‐2003BK040082‐0TerumoMedicalCorporation125BlueBallRoadElkton,MD21921TradeName:TSCD‐IITerumoSterileTubingWelderClearedDate:05‐APR‐2005BK070018‐0TerumoMedicalCorporation125BlueBallRoadElkton,MD21921TradeName:TRUCISETotalSystemClearedDate:22‐JAN‐2008BK110071‐0TerumoMedicalCorporation950ElktonBlvdElkton,MD21921TradeName:TSCD(R)IISterileTubingWelder&TruciseTotalSystem(R)ClearedDate:12‐SEP‐2012BK980002‐0TevaMedicalLTD482HudsonTerraceEnglewoodCliffs,NJ07632TradeName:SegMedClearedDate:02‐MAR‐1998BK060060‐0TexasBioGene,Inc.
635PresidentialDriveRichardson,TX75081TradeName:MorganHLASSPABDRTypingKitClearedDate:22‐MAR‐2007BK080039‐0TexasBioGene,Inc.
635PresidentialDriveRichardson,TX75081TradeName:MorganHLASSPABCDRDQTypingKitClearedDate:22‐APR‐2009BK050058‐0TheSurgicalCompanyInternationalTerminalweg19aAmersfoort,NETHERLANDS3821AJTradeName:FluidoBloodandFluidWarmerSystemClearedDate:05‐MAY‐2006BK070055‐0TheSurgicalCompanyInternationalTerminalweg19aAmersfoort,NETHERLANDS3821AJTradeName:FluidoAirGuardFluidoCompressorFluidoIV‐PoleFluidoPressureChamberClearedDate:15‐JAN‐2008BK950067‐0ThermalTransferTechnology681MainStreetPlacerville,CA95667TradeName:ThermalWareClearedDate:14‐FEB‐1996BK160044‐0ThermoElectronLEDGmbH(asubsidiaryofThermoFisherScientificInc.
)AmKalkbergOsterodeamHarz,TradeName:ThermoScientificCW3CellWasherClearedDate:07‐OCT‐2016BK180198‐0ThermoGenesisCorp2700CitrusRdRancoCordova,CA75741TradeName:AXPIIAutoXpressPlatformClearedDate:14‐NOV‐2018BK960072‐0Thermogenesis3146GoldCampDriveSuite206RanchoCordova,CA95670‐6022TradeName:CryoSealSystemClearedDate:12‐FEB‐1999BK960074‐0Thermogenesis3146GoldCampDriveSuite206RanchoCordova,CA95670‐6022TradeName:HemoMaticBloodCollectionMonitorClearedDate:03‐APR‐1997BK030011‐0Thermogenesis3146GoldCampDriveSuite206RanchoCordova,CA95670‐6022TradeName:ThermoGenesisThawerClearedDate:10‐JUN‐2003BK070006‐0Thermogenesis2711CitrusRoadRanchoCordova,CA95742TradeName:AXPAutoXpressPlatformClearedDate:05‐OCT‐2007BK100066‐0Thermogenesis2711CitrusRoadRanchoCordova,CA95742TradeName:ThermoGenesisRes‐Q60PRPDeviceClearedDate:27‐MAY‐2011BK900017‐0ThermopolInc.
2481BDeltaLn,ElkGroveVillage,IL60007TradeName:SolidStatePortableRefrigeratorClearedDate:30‐AUG‐1990BK940038‐0Thomson&Neilsen,Ltd.
1050BaxterRoadOttawa,Ontario,Canada,CANADATradeName:BloodIrradiatorDosimetrySystemTN‐ID‐50ClearedDate:18‐OCT‐1994BK150289‐0TimestripUKLtd.
22FriarsStreetSudbury,SuffolkUNITEDKINGDOMCO102AATradeName:Timestrip(R)BloodTemp10(BT10)ClearedDate:14‐DEC‐2015BK190363‐0TimestripUKLtd.
22FriarsStreetSudbury,SuffolkUNITEDKINGDOMCO102AATradeName:TimestripBloodTemp10ClearedDate:22‐JUL‐2019BK850007‐0Trayser,Inc.
P.
O.
Box83CabinJohn,MD20818TradeName:TrayserDR/DQTypingTrayKitClearedDate:25‐APR‐1985BK030066‐0TycoHealthcare15HampshireStreetMansfield,MA02048TradeName:KendallLIFETRACEUmbilicalBloodCollectionKitClearedDate:03‐NOV‐2003BK070037‐0TypenexMedicalLLC303EastWackerDriveSuite311Chicago,IL60601TradeName:TypeSafeSegmentDispenserClearedDate:05‐OCT‐2007BK150351‐0TypenexMedicalLLC303EastWackerDriveSuite311Chicago,IL60601TradeName:Typesafe2.
0SegmentPiercingDevice(ModelNumberSP0201QD&SP0201QM)ClearedDate:28‐DEC‐2015BK820012‐0UCLATissueTypingLaboratory1000VeteranAvenueLosAngeles,CA90024TradeName:HLATypingTrayClearedDate:04‐MAR‐1983BK970026‐0UtahMedicalProducts,Inc.
7043South300WestMidvale,UT84047TradeName:UmbilicupClearedDate:28‐JAN‐1998BK970027‐0UtahMedicalProducts,Inc.
7043South300WestMidvale,UT84047TradeName:UmbilicupIICordBloodSystemClearedDate:06‐JAN‐1998BK010043‐0VEEGEEScientific13600NE126thPlaceSuiteAKirkland,WA98034TradeName:AtagoSP‐D2RefractometerClearedDate:02‐JAN‐2002BK870008‐0ValTechDiagnostics14WernerCampRoadPittsburgh,PA15238TradeName:NormalSaline‐BufferedClearedDate:31‐JUL‐1987BK880004‐0ValTechDiagnostics14WernerCampRoadPittsburgh,PA15238TradeName:BufferedNormalSalineConcentrateClearedDate:11‐APR‐1988BK070044‐0VeraxBiomedicalIncorporated148BartlettStreetMarlborough,MA01752TradeName:PlateletPGDControlsPlateletPGDTestClearedDate:17‐SEP‐2007BK090028‐0VeraxBiomedicalIncorporated148BartlettStreetMarlborough,MA01752TradeName:PlateletPGDTestSystemClearedDate:10‐NOV‐2009BK110014‐0VeraxBiomedicalIncorporated148BartlettStreetMarlborough,MA01752TradeName:PlateletPGDTestSystemClearedDate:08‐SEP‐2011BK140201‐0VeraxBiomedicalIncorporated148BartlettStreetMarlborough,MA01752TradeName:PlateletPGD(R)TestSystemClearedDate:13‐MAY‐2015BK160087‐0VeraxBiomedicalIncorporated148BartlettStreetMarlborough,MA01752TradeName:PlateletPGDTestSystemClearedDate:06‐APR‐2017BK120008‐0VerticalSpine,LLC2201MarconiRoadWall,NJ07719TradeName:FIBRINET(R)AutologousPRPSystemClearedDate:01‐AUG‐2012ClearedUnderCascadeMedicalEnterprises,LLCBK020005‐0VisibleGenetics,Inc.
700BAYStreet,Suite1000Toronto,OntarioM5G1Z6CANADATradeName:TrugeneHIV‐1GenotypingKitandOpenGeneDNASequencingSystemClearedDate:24‐APR‐2002BK020042‐0VisibleGenetics,Inc.
700BAYStreet,Suite1000Toronto,OntarioM5G1Z6CANADATradeName:TRUGENEHIV‐1GenotypingKitandOpenGeneDNASequencingSystemClearedDate:07‐NOV‐2002BK030015‐0VisibleGenetics,Inc.
700BAYStreet,Suite1000Toronto,OntarioM5G1Z6CANADATradeName:TRUGENEHIV‐1GenotypingKitandOpenGeneDNASequencingSystemClearedDate:14‐MAR‐2003BK910010‐0WHITTAKERBIOPRODUCTS,INC.
8830BiggsFordRoadWalkersville,MO21793TradeName:ENDOTOXINCHALLENGEVIALSClearedDate:09‐AUG‐1991BK860039‐0WakoChemicals,USA,Inc.
12300FordRoad,Suite130Dallas,TX75234TradeName:ToxinometerET‐201ClearedDate:10‐FEB‐1987BK200479‐0WellSkyCorporation1300SwitzerRdOverlandParl,KS66210TradeName:WellSkyBlood–EmergencyIssue2020R1ClearedDate:12‐JUN‐2020BK910005‐0WhitmanMedicalCorporation990RaritanRoadClark,NJ07066TradeName:Safe‐T‐VueIrreversibleTemperatureIndicatorClearedDate:12‐MAY‐1992BK950059‐0WyndgateTechnologies11121SunCenterDriveSuiteCRanchoCordova,CA95670TradeName:SafeTraceClearedDate:14‐APR‐1997BK980023‐0WyndgateTechnologies11060WhiteRockRoadSuite200RanchoCordova,CA95670TradeName:SafeTraceTX,version1.
0ClearedDate:29‐JAN‐1999BK070010‐0WyndgateTechnologies4925RobertJ.
MatthewsParkwaySuite100ElDoradoHills,CA95762TradeName:ElDoradoDonorDoc‐1.
0.
0ClearedDate:23‐MAY‐2007BK070064‐0WyndgateTechnologies4925RobertJ.
MatthewsParkwaySuite100ElDoradoHills,CA95762TradeName:ElDoradoDonor‐1.
0.
0ClearedDate:13‐FEB‐2008BK090026‐0WyndgateTechnologies4925RobertJ.
MatthewsParkwaySuite100ElDoradoHills,CA95762TradeName:SafeTraceTxClearedDate:03‐SEP‐2009BK090033‐0WyndgateTechnologies4925RobertJ.
MatthewsParkwaySuite100ElDoradoHills,CA95762TradeName:ElDorodoDonorDocClearedDate:28‐OCT‐2009BK090063‐0WyndgateTechnologies4925RobertJ.
MatthewsParkwaySuite100ElDoradoHills,CA95762TradeName:TestResultInterfaceforElDoradoDonorClearedDate:20‐NOV‐2009BK100002‐0WyndgateTechnologies4925RobertJ.
MatthewsParkwaySuite100ElDoradoHills,CA95762TradeName:ComponentManufacturingInterfaceforElDoradoDonorClearedDate:24‐FEB‐2010BK860005‐0bioMerieux,Inc.
5300S.
PortlandAvenueOklahomaCity,OK73119TradeName:PlasmaCollectionBagClearedDate:19‐DEC‐1986ClearedUnderBioMerieux,Inc.
BK870019‐0bioMerieux,Inc.
5300S.
PortlandAvenueOklahomaCity,OK73119TradeName:Quik‐ChekClearedDate:19‐MAY‐1988ClearedUnderBioMerieux,Inc.
BK880003‐0bioMerieux,Inc.
5300S.
PortlandAvenueOklahomaCity,OK73119TradeName:TherapeuticPlasmapheresisCollectionBagClearedDate:11‐MAR‐1988ClearedUnderBioMerieux,Inc.
BK920037‐0bioMerieux,Inc.
5300S.
PortlandAvenueOklahomaCity,OK73119TradeName:PEG+ClearedDate:21‐OCT‐1993ClearedUnderBioMerieux,Inc.
BK960026‐0bioMerieux,Inc.
100AkzoAvenueDurham,NC27712TradeName:StatusSymbolTMIISystemSoftwareClearedDate:16‐MAR‐1999ClearedUnderOrganonTeknikaCorporationBK000042‐0bioMerieux,Inc.
100AkzoAvenueDurham,NC27712TradeName:BacT/ALERTCultureBottlesClearedDate:15‐FEB‐2002ClearedUnderBioMerieux,Inc.
BK020022‐0bioMerieux,Inc.
100RodolpheStreetDurham,NC27712TradeName:BacT/ALERTSNCultureBottleClearedDate:10‐OCT‐2002ClearedUnderBioMerieux,Inc.
BK020023‐0bioMerieux,Inc.
100RodolpheStreetDurham,NC27712TradeName:BacT/ALERTSACultureBottleClearedDate:10‐OCT‐2002ClearedUnderBioMerieux,Inc.
BK020060‐0bioMerieux,Inc.
100RodolpheStreetDurham,NC27712TradeName:NuclieSensHIV‐1QTRNAExternalControlsClearedDate:18‐DEC‐2002ClearedUnderBioMerieux,Inc.
BK030034‐0bioMerieux,Inc.
100RodolpheStreetDurham,NC27712TradeName:BacT/ALERTBPNCultureBottleClearedDate:18‐JUL‐2003ClearedUnderBioMerieux,Inc.
BK030035‐0bioMerieux,Inc.
100RodolpheStreetDurham,NC27712TradeName:BacT/ALERTBPACultureBottleClearedDate:06‐AUG‐2003ClearedUnderBioMerieux,Inc.
BK030075‐0bioMerieux,Inc.
100RodolpheStreetDurham,NC27712TradeName:BacT/ALERTBPNCultureBottlesClearedDate:08‐MAR‐2004ClearedUnderBioMerieux,Inc.
BK030076‐0bioMerieux,Inc.
100RodolpheStreetDurham,NC27712TradeName:BacT/ALERTBPACultureBottlesClearedDate:08‐MAR‐2004ClearedUnderBioMerieux,Inc.
BK050037‐0bioMerieux,Inc.
100RodolpheStreetDurham,NC27712TradeName:BacT/ALERTBPACultureBottleClearedDate:27‐DEC‐2005ClearedUnderBioMerieux,Inc.
BK050043‐0bioMerieux,Inc.
100RodolpheStreetDurham,NC27712TradeName:BacT/ALERTBPNCultureBottleClearedDate:27‐DEC‐2005ClearedUnderBioMerieux,Inc.
BK170142‐0bioMerieux,Inc.
595AnglumRoadHazelwood,MO63042TradeName:BacT/ALERTBPACultureBottleBacT/ALERTBPNCultureBottleClearedDate:01‐FEB‐2018BK180266‐0bioMerieux,Inc.
595AnglumRoadHazelwood,MO63042TradeName:BACT/ALERTBPACultureBottleBACT/ALERTBPNCultureBottleClearedDate:29‐NOV‐2018BK200472‐0bioMerieux,Inc.
595AnglumRoadHazelwood,MO63042TradeName:BACT/ALERTBPACultureBottleBACT/ALERTBPNCultureBottleClearedDate:20‐MAY‐2020BK040018‐0siennapartnersP.
O.
Box103Baldwin,MD21013TradeName:VacuetteEDTAK2tube;VacuetteEDTAK3tubeClearedDate:28‐JUL‐2004