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  1. Vaccines, Blood & Biologics

CBER-Regulated Products with Supporting Documents

The list below includes products for which we have supporting documentation. The list is arranged alphabetically by the proper name of the product(s). Information is provided for original product approvals, new indications, and the current package insert.

Licensed Biological Products with Supporting Documents
ProductTrade NameManufacturer
A  
NoneAptima HIV-1 Quant Dx AssayHologic, Inc.
NoneAdenovirus Type 4 and Type 7 Vaccine, Live, OralBarr Labs, Inc.
Acellular tissue engineered vessel-tyodSYMVESSHumacyte Global, Inc.
ADAMTS13, recombinant-krhnADZYNMATakeda Pharmaceuticals U.S.A., Inc.
afamitresgene autoleucelTECELRAAdaptimmune LLC
Anti-Human Globulin (Murine Monoclonal)Automated C3d PlateImmucor, Inc.
Anthrax Vaccine Adsorbed, AdjuvantedCYFENDUSEmergent Product Development Gaitherburg, Inc.
antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtlALTUVIIIOBioverativ Therapeutics Inc., a Sanofi Company
ALBAclone® Anti-Fyb (Human/Murine Monoclonal)ALBAclone Anti-Fyb (Human/Murine Monoclonal)Alba Bioscience Limited
AlbuminALBUMINEXBio Products Laboratory, USA
AlbuminAlbumin (Human) (None)Octapharma Pharmazeutika Produktionsgesm.b.H
Albumin KedbuminKedrion Biopharmaceuticals, SpA
Allergen Extract Sublingual TabletsGRASTEKMerck Sharp & Dohme Corp
Allergen Extract Sublingual TabletsODACTRAMerck Sharp & Dohme Corp
Allergen Extract Sublingual TabletsORALAIRStallergenes S.A.
Allergen Extract Sublingual TabletsRAGWITEKMerck Sharp & Dohme Corp
Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine CollagenGINTUITOrganogenesis Incorporated
allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen- dsatSTRATAGRAFTStratatech Corporation
allogeneic processed thymus tissue-agdcRETHYMICEnzyvant Therapeutics GmbH
Alpha1-Proteinase Inhibitor (Human)Aralast NPBaxter Healthcare Corporation
Alpha1-Proteinase Inhibitor (Human)AralastBaxter Healthcare Corporation
Alpha1-Proteinase Inhibitor (Human)GLASSIAKamada Ltd.
Alpha1-Proteinase Inhibitor (Human)ProlastinTalecris Biotherapeutics, Inc.
Alpha1-Proteinase Inhibitor (Human)Prolastin-CTalecris Biotherapeutics, Inc.
Alpha1-Proteinase Inhibitor (Human)ZemairaAventis Behring L.L.C.
NoneAlinity m HIV-1Abbott Molecular, Inc
Anthrax Immune globulin IntravenousAnthrasilCangene Corporation
Anthrax Vaccine AdsorbedBiothraxEmergent BioDefense Operations Lansing, Inc
Anti-B (Murine Monoclonal)None [Anti-B (Murine Monoclonal)]Immucor, Inc
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme-Linked Immunosorbent Assay (ELISA)Genetic Systems HBsAg EIA 3.0Bio-Rad Laboratories
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal)Enzyme Immuno Assay (EIA)/Monoclonal)Auszyme MonoclonalAbbott Laboratories
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM); Antibody to Hepatitis B Surface Antigen (Human)ABBOTT PRISM HBsAg; ABBOTT PRISM HBsAg ConfirmatoryAbbott Laboratories
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgG and IgM) and Antibody to Hepatitis B Surface Antigen (Sheep)Alinity s HBsAg and Alinity s HBsAg ConfirmatoryAbbott Ireland Diagnostics Division
Antihemophilic Factor (Recombinant)Kogenate FSBayer Corp
Antihemophilic Factor (Recombinant)KOVALTRYBayer HealthCare LLC
Antihemophilic Factor (Recombinant)ReFactoGenetics Institute, Inc
Antihemophilic Factor (Recombinant)RecombinateBaxter Healthcare Corporation
Antihemophilic Factor (Recombinant)NovoeightNovo Nordisk
Antihemophilic Factor (Recombinant)NUWIQOctapharma USA, Inc
Antihemophilic (Recombinant), FcFusion ProteinELOCTATEBiogen Idec, Inc.
Antihemophilic Factor (Recombinant), GlycoPEGylated-exeiEsperoctNovo Nordisk, Inc.
Antihemophilic Factor (Recombinant), PEGylatedADYNOVATETakeda Pharmaceuticals U.S.A., Inc.
Antihemophilic Factor (Recombinant), PEGylated-auclJIVIBayer Healthcare, Inc
Antihemophilic Factor (Recombinant), Plasma/Albumin FreeXYNTHAWyeth Pharmaceuticals, Inc
Antihemophilic Factor (Recombinant), Plasma/Albumin Free MethodAdvateBaxter Healthcare Corp
Antihemophilic Factor (Recombinant), Porcine SequenceOBIZURBaxter Healthcare Corporation
Antihemophilic Factor (Recombinant), Single ChainAFSTYLACSL Behring, LLC
Antihemophilic Factor/von Willebrand Factor Complex (Human)Humate-PCSL Behring GmbH
Antihemophilic Factor/von Willebrand Factor Complex (Human)AlphanateGrifols Biologicals, Inc
Anti-Human GlobulinAnti-Human Globulin Solidscreen IIBiotest AG
Anti-Human GlobulinAnti-Human Globulin (Formulated for Automated Testing)Bio-Rad Medical Diagnostics GmbH
Anti-Human GlobulinAnti-Human Globulin (Rabbit/Murine Monoclonal) (Formulated for Automated Testing)Bio-Rad Medical Diagnostics GmbH
Anti-Human GlobulinMTS Anti-IgG CardMicro Typing Systems, Inc.
Anti-Human Globulin (Rabbit/Murine Monoclonal)DG Gel 8 Direct Coombs (Anti-IgG, -C3d)Diagnostic Grifols, S.A.
Anti-Human Globulin (Murine Monoclonal)DG Gel 8 Direct Coombs (Anti-C3d)Diagnostic Grifols, S.A.
Anti-Human Globulin (Murine Monoclonal) (For Further Manufacturing Use)Anti-Human Globulin Anti-C3d FFMU, Murine MonoclonalDiagast
Anti-Human Globulin (Rabbit/Murine Monoclonal) (For Further Manufacturing Use)Anti-Human Globulin Anti-IgG, -C3d FFMU, Rabbit Polyclonal/Murine MonoclonalDiagast
Anti-Inhibitor Coagulant ComplexFEIBABaxter Healthcare Corp
Antithrombin (Recombinant)ATrynGTC Biotherapeutics, Inc
Anti-thymocyte Globulin (Rabbit)ThymoglobulinGenzyme Corp
atidarsagene autotemcelLENMELDYOrchard Therapeutics (Europe) Limited
Autologous Cultured ChondrocytesMACIVericel Corporation
axicabtagene ciloleucelYESCARTAKite Pharma Inc.
Azficel-TLAVIVFibrocell Technologies, Inc.
Return to A - Z List  
B  
BCG LiveBCG VaccineOrganon Teknika Corp
BCG LiveTICE BCGOrganon Teknika Corp
beremagene geperpavecVYJUVEKKrystal Biotech, Inc.
betibeglogene autotemcelZYNTEGLObluebird bio Inc.
Blood Grouping Reagents (Formulated for Automated Testing)Blood Grouping Reagents (Murine Monoclonal) IH-Card (STN# 125094- 097; 125202 -  206)Bio-Rad Medical Diagnostics GmbH
Blood Grouping ReagentsBlood Grouping Reagent, Anti-A (Murine Monoclonal) (FFMU) STN# 125669 & 125680Diagast
Blood Grouping ReagentsBlood Grouping Reagent, Anti-k (Monoclonal) (IgG) (For Further Manufacturing Use)Millipore (UK) Ltd.
Blood Grouping Reagent, Anti-B (Murine Monoclonal) (IgG)(Formulated for Automated Testing)Anti-B (Murine Monoclonal) (IgG)(Formulated for Automated Testing)Bio-Rad Medical Diagnostics GmbH
Blood Grouping Reagent, Anti-D (Monoclonal Blend)(Formulated for Automated Testing)Anti-D (Monoclonal Blend)(Formulated for Automated Testing)Bio-Rad Medical Diagnostics GmbH
Blood Grouping Reagent, Anti-Lea (Murine Monoclonal)(For Further Manufacturing Use)N/AMillipore (UK) Ltd.
Blood Grouping Reagent, Anti-Leb (Murine Monoclonal)(For Further Manufacturing Use)N/AMillipore (UK) Ltd.
Blood Grouping Reagents, Anti-C (Monoclonal), Anti-E (Monoclonal), Anti-e (Monoclonal), Anti-c (Monoclonal)MTS Anti-C (Monoclonal) Card, Anti-E (Monoclonal) Card, Anti-e (Monoclonal) Card, Anti-c (Monoclonal) CardMicro Typing Systems
Blood Grouping ReagentBlood Grouping Reagent, Anti-Fyb (Monoclonal)Immucor, Inc.
Blood Grouping ReagentBlood Grouping Reagent, Anti-Cw (Monoclonal)Immucor, Inc.
Blood Grouping ReagentBlood Grouping Reagent, Anti-k (Monoclonal)Immucor, Inc.
Blood Grouping ReagentsAnti-Fya (Murine Monoclonal) (Recombinant)Siwa Biotech Corp.
Blood Grouping ReagentsAnti-Fyb (Murine Monoclonal) (Recombinant)Siwa Biotech Corp.
Blood Grouping ReagentsALBAcloneAlba Bioscience, Inc
Blood Grouping ReagentsBlood Grouping Reagents, Anti-Fya, Anti-Jka, Anti-Jkb, Anti-S, Anti-s, Anti-K, Anti-P1Alba Bioscience Limited
Blood Grouping ReagentsBlood Grouping Regents, BL 101728-34;103292American National Red Cross
Blood Grouping ReagentsORTHO SeraAlba Bioscience Limted
Blood Grouping ReagentsORTHO Sera Anti-D (IAT) (Monoclonal Blend) Blood Grouping ReagentAlba Bioscience Limited (Alba)
Blood Grouping ReagentsDiagast Bundled BLA 125615, 125619 to 125626Diagast
Blood Grouping ReagentComponent of Erytype SBiotest Medical Diagnostics GmbH
Blood Grouping ReagentErytype SBiotest Medical Diagnostics GmbH
Blood Grouping ReagentMTS Anti-A (Murine Monoclonal) Card;  Anti-B (Murine Monoclonal) Card;
Anti-A,B (Murine Monoclonal) Card, Anti-D (Murine Monoclonal) (IgM) Card
Micro Typing Systems, Inc.
Blood Grouping Reagent0.8% SELECTOGEN; 0.8% SURGISCREEN; 0.8% AFFIRMAGEN; 0.8% RESOLVE PANELS A, B, C; 0.8% POOLING SCREENING CELLSOrtho-Clinical Diagnostics, Inc.
Blood Grouping Reagents (ALBAsera)Anti-Fya ALBAseraAlba Bioscience Limited
Blood Grouping Reagents (ALBAsera)Anti-Fyb ALBAseraAlba Bioscience Limited
Blood Grouping Reagents (ALBAsera)Anti-Wra ALBAseraAlba Bioscience Limited
Blood Grouping Reagents (ALBAsera)Anti-s ALBAseraAlba Bioscience Limited
Blood Grouping Reagents (ALBAsera)Anti-K ALBAseraAlba Bioscience Limited
Blood Grouping Reagent, Anti (Monoclonal)DG Gel 8 ABO/Rh (2D)Diagnostic Grifols, S.A.
Blood Grouping Reagant Anti-Fya (Monoclonal)Seraclone Blood Grouping Reagent Anti-Fya(Monoclonal)Biotest Medical Diagnostics GmbH
Blood Grouping Reagent Anti-s (Monoclonal)SeracloneBiotest Medical Diagnostics GmbH
Blood Grouping Reagent Anti-S (Monoclonal)SeracloneBiotest Medical Diagnostics GmbH
Blood Grouping Reagents and Anti-Human Globulin ReagentsSeraclone Blood Grouping Reagents and Anti-Human Globulin Reagents (STN# 125213, 125215, 125217, 125219 - 125233, 125242)Biotest Medical Diagnostics GmbH
Blood Grouping Reagent Combination KitDG Gel Card 125445, 125449, 125450 - 125457Diagnostic Grifols, S. A.
Blood Grouping Reagent Combination KitMicro Typing System A/B; MTS A/B/D; MTS A/B/D/Reverse and MTS Monoclonal Rh Phenotype CardMicro Typing Systems, Inc
Blood Grouping Reagent (Human/Murine Monoclonal)Anti-C, Anti-e, Anti-CwAlba Bioscience Limited
Botulism Immune Globulin Intravenous (Human)BabyBIGCalifornia Department of Health Services
brexucabtagene autoleucelTECARTUSKite Pharma, Inc.
Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)None [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)]Cangene Corporation
Return to A - Z List  
C  
Chikungunya Vaccine, LiveIXCHIQValneva Austria GmbH
ciltacabtagene autoleucelCARVYKTIJanssen Biotech, Inc.
C1 Esterase Inhibitor (Human)BerinertCSL Behring GmbH
C1 Esterase Inhibitor (Human)CinryzeLev Pharmaceuticals, Inc
C1 Esterase Inhibitor (Human)HAEGARDACSL Behring GmbH
C1 Esterase Inhibitor
(Recombinant)
RUCONESTSalix Pharmaceuticals, Inc.
Candida albicans Skin Test Antigen For Cellular HypersensitivityCANDINNielson BioSciences Inc.
Cholera Vaccine, Live, OralVAXCHORAPax Vax Bermuda Ltd.
Coagulation Factor VIIa (Recombinant)NovoSevenNovoNordisk, Inc
Coagulation Factor VIIa (Recombinant)NovoSevenRTNovoNordisk, Inc
Coagulation Factor IX (Recombinant)ALPROLIXBioverativ Therapeutics, Inc.
Coagulation Factor IX (Recombinant)BenefixWyeth Pharmaceuticals
Coagulation Factor IX (Recombinant)IXINITYMedexus Pharma, Inc.
Coagulation Factor IX (Recombinant)RIXUBISBaxter Healthcare Corporation
Coagulation Factor IX (Recombinant), Albumin Fusion ProteinIDELVIONCSL Behring Recombinant Facility AG
Coagulation Factor IX (Recombinant), GlycoPEGylatedREBINYNNovo Nordisk Inc.
Coagulation Factor X (Human)COAGADEXBio Products Laboratory USA, Inc.
coagulation factor Xa (recombinant), inactivated-zhzoANDEXXAPortola Pharmaceuticals, Inc.
Coagulation Factor XIII A-Subunit (Recombinant)TRETTENNovo Nordisk, Inc
coagulation factor Vlla (recombinant)-jncwSEVENFACTLaboratoire Francais du Fractionnement et des Biotechnologies S.A. (LFB S.A)
Nonecobas HIV-1/HIV-2 QualitativeRoche Molecular Systems, Inc.
cobas® Zika, Nucleic acid test for use on the cobas® 6800/8800 systemscobas ZikaRoche Molecular Systems, Inc
cobas® Babesia test for use on the cobas® 6800/8800 Systemscobas BabesiaRoche Molecular Systems, Inc.
cobas® Malaria test for use on the cobas® 6800/8800 Systemscobas® MalariaRoche Molecular Systems
Coccidioides immitis Spherule - Derived Skin Test AntigenSpherusolAllermed Laboratories, Inc.
COVID-19 Vaccine mRNAComirnatyBioNTech Manufacturing GmbH
COVID-19 Vaccine, mRNASPIKEVAXModernaTx, Inc
Crotalidae Immune F(ab’)2 (Equine)ANAVIPInstituto Bioclon, S.A. de C.V.
Cytomegalovirus Immune Globulin Intravenous (Human)CytoGamCSL Behring LLC
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D  
delandistrogene moxeparvovec-roklELEVIDYSSarepta Therapeutics, Inc.
NoneDPP HIV-Syphilis SystemChembio Diagnostic Systems, Inc.
Dermatophagoides pteronyssinusStandardized Mite ExtractJubiliant HollisterStier LLC
Dermatophagoides farinaeStandardized Mite ExtractJubiliant HollisterStier LLC
DENGUE Tetravalent Vaccine, LiveDENGVAXIASanofi Pasteur, Inc.
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine AdsorbedDAPTACELSanofi Pasteur, Ltd
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine AdsorbedINFANRIXGlaxoSmithKline Biologicals
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine CombinedPediarixGlaxoSmithKline Biologicals
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus VaccineKINRIXGlaxoSmithKline Biologicals
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus VaccineQuadracelSanofi Pasteur Limited
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) VaccinePentacelSanofi Pasteur, Ltd
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] VaccineVAXELISMCM Vaccine Company
donislecelLANTIDRACellTrans Inc.
Return to A - Z List  
E  
eladocagene exuparvovec-tneqKEBILIDIPTC Therapeutics
Elecsys Anti-HBc IIElecsys Anti-HBc IIRoche Diagnostics
Elecsys Anti-HCV IIElecsys Anti-HCV IIRoche Diagnostics
Elecsys ChagasElecsys ChagasRoche Diagnostics
Elecsys HBsAg II and Elecsys HBsAg II Auto ConfirmElecsys HBsAg II and Elecsys HBsAg II Auto ConfirmRoche Diagnostics
Elecsys HIV DuoElecsys HIV DuoRoche Diagnostics
Elecsys HIV DuoElecsys HIV DuoRoche Diagnostics
Elecsys HTLV-I/IIElecsys HTLV-I/IIRoche Diagnostics
Ebola Zaire Vaccine, LiveERVEBOMerck Sharp & Dohme LLC
elivaldogene autotemcelSKYSONAbluebird bio, Inc.
etranacogene dezaparvovec-drlbHEMGENIXCSL Behring LLC
exagamglogene Autotemcel (exa-cel)CASGEVYVertex Pharmaceuticals Incorporated
Return to A - Z List  
F  
Factor IX ComplexProfilnine SDGrifols Biologicals Inc.
Factor XIII Concentrate (Human)CorifactCSL Behring. GmbH
fecal microbiota spores, live-brpkVOWSTSeres Therapeutics, Inc.
fecal microbiota, live-jslmREBYOTAFerring Pharmaceuticals Inc.
Fidanacogene elaparvovec-dzktBEQVEZPfizer, Inc.
Fibrin Sealants TopicalVISTASEALInstituto Grifols, S.A.
Fibrin Sealants TopicalRAPLIXAThe Medicines Company
Fibrin Sealants TopicalTISSEELBaxter Healthcare Corp
Fibrin Sealants TopicalARTISSBaxter Healthcare Corp
Fibrin Sealants TopicalEvicelOmrix Biopharmaceuticals, Ltd
Fibrin Sealant Patch, AbsorbableEVARRESTEthicon, Inc
Fibrin Sealant Patch, AbsorbableTachoSilNycomed Danmark ApS
Fibrinogen (Human)FIBRYGAOctapharma Pharmazeutika Produktionsges.m.b.H.
Fibrinogen Concentrate (Human)RIASTAPCSL Behring GmbH
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H  
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) VaccineCOMVAX (Discontinued)Merck &Co, Inc
Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate)PedvaxHIBMerck Sharp & Dohme Corp.
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)HiberixGlaxoSmithKline Biologicals, S.A.
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)ActHIBSanofi Pasteur, SA
Hepatitis A Inactivated and Hepatitis B (Recombinant) VaccineTWINRIXGlaxoSmithKline Biologicals
Hepatitis A Vaccine, InactivatedHavrixGlaxoSmithKline Biologicals
Hepatitis A Vaccine, InactivatedVAQTAMerck Co, Inc
Hepatitis B Immune Globulin (Human)Nabi-HBNabi Biopharmaceuticals
Hepatitis B Immune Globulin Intravenous (Human)HepaGam BCangene Corp
Hepatitis B Vaccine (Recombinant)Recombivax HBMerck Co, Inc
Hepatitis B Vaccine (Recombinant)ENGERIX-BGlaxoSmithKline Biologicals
Hepatitis B Vaccine (Recombinant)PREHEVBRIOVBI Vaccines (Delaware) Inc.
Hepatitis B Vaccine (Recombinant), AdjuvantedHEPLISAV-BDynavax Technologies Corporation
Hepatitis B Virus Core Antigen (E.coli, Recombinant)ABBOTT PRISM HBcoreAbbott Laboratories
Hepatitis B Virus Core Antigen (E. coli, Recombinant)Alinity s Anti-HBcAbbott GmbH & Co. KG
Hepatitis B Virus (Hepatitis B Virus/Polymerase Chain Reaction/Blood Cell Derived)COBAS AmpliScreen HBV TestRoche Molecular Systems, Inc
Hepatitis C Virus (E coli, Recombinant) NS3 Helicase Antigens and Synthetic Core PeptideAlinity s Anti-HCV II assayAbbott GmbH
Hepatitis C Virus (Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived)COBAS AmpliScreen HCV Test, version 2.0Roche Molecular Systems, Inc
Hepatitis C Virus Encoded Antigen (HCV Encoded Antigen/Enzyme Immuno Assay (EIA)/Recombinant)ABBOTT HCV EIA 2.0Abbott Laboratories
Hepatitis C Virus Encoded Antigen (HCV Encoded Antigen/Enzyme Immuno Assay (EIA), Version 3.0/Recombinant and Synthetic)Ortho HCV Version 3.0 ELISA Test SystemOrtho-Clinical Diagnostics, Inc.
Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43, NS5)ABBOTT PRISM HCVAbbott Laboratories
Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43)Alinity s Anti-HCVAbbott GmBH & Co. KG
Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic) (RIBA)CHIRON RIBA HCV 3.0 Strip Immunoblot AssayNovartis Vaccines and Diagnostics, Inc
Hepatitis C Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) AssayUltraQual HCV-RT-PCR-AssayNational Genetics Institute
Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assayNone [Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay]BioLife Plasma Services, LP
HPC, Cord BloodALLOCORDSSM Cardinal Glennon Children's Medical Center
HPC, Cord BloodClevecordCleveland Cord Blood Center
HPC, Cord BloodDucordDuke University School of Medicine, Carolinas
HPC, Cord BloodHemacordNew York Blood Center, Inc
HPC, Cord BloodREGENECYTEStemCyte, Inc.
HPC, Cord BloodNone [HPC, Cord Blood]Bloodworks
HPC, Cord BloodNone [HPC, Cord Blood]Clinimmune Labs, University of Colorado Cord Blood Bank
HPC, Cord BloodNone [HPC, Cord Blood]LifeSouth Community Blood Centers, Inc.
HPC, Cord BloodNone [HPC, Cord Blood]MD Anderson Cord Blood Bank
HIV Supplemental AssayVioOne HIV Profile Supplemental AssayAvioq, Inc.
Human Immunodeficiency Virus Type IGenetic Systems rLAV EIABio-Rad Laboratories
Human Immunodeficiency Virus Type 1 (HIV-1)HIV-1 (Western Blot)Maxim Biomedical, Inc
Human Immunodeficiency Virus Type 1 (HIV-1 Nucleic Acid Testing/Synthetic)APTIMA HIV-1 RNA Qualitative AssayGen-Probe, Inc
HIV-1 Group O and M, HIV-2, HCV and/or HBV (HIV-1/HIV-2/HCV/HBV/Multiplex Discriminatory NAT)cobas TaqScreen MPX Test, version 2.0 for use with the cobas s 201 systemRoche Molecular Systems, Inc.
Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA AssayCOBAS TaqScreen MPX TestRoche Molecular Systems, Inc.
Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and Hepatitis C Virus and Hepatitis B Virus/Nucleic Acid Pooled Testing/Synthetic)Procleix Ultrio AssayGen-Probe, Inc
Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and Hepatitis C Virus and Hepatitis B Virus/Nucleic Acid Pooled Testing/Synthetic)Procleix Ultrio Plus AssaysGen-Probe, Inc
Human Immunodeficiency Virus Type 1 and / or Hepatitis C Virus (HIV-1 and Hepatitis C Virus / Nucleic Acid Pooled Testing / Synthetic)Procleix HIV-1/HCV AssayGen-Probe, Inc
Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assayNone [Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay]BioLife Plasma Services, L.P.
Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen and Synthetic Peptide (ChLIA)ABBOTT PRISM HIV O PlusAbbott Park, IL
Human Immunodeficiency Virus Types 1 and 2 (E coli, B megaterium, Recombinant) Antigen, Antibody (p24) and Synthetic PeptidesAlinity s HIV Ag/Ab Combo Reagent KitAbbott GmbH & Co. KG
Human T-Lymphotropic Virus Types I and II (E coli, Recombinant) Antigen and Synthetic PeptidesAlinity s HTLV I/IIAbbott GmbH & Co. KG
Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptides)Geenius HIV 1/2 Supplemental AssayBio-Rad Laboratories, Inc.
Human Immunodeficiency Virus Types 1 and 2/Enzyme Immuno Assay (EIA) / Recombinant)HIVAB HIV-1/HIV-2 (rDNA) EIAAbbott Laboratories
Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2/Enzyme Immunoassay (EIA)/Recombinant and Synthetic)Genetic Systems HIV-1/HIV-2 Plus O EIABio-Rad Laboratories
Human Immunodeficiency Virus Type 1 Reverse Transcriptase Polymerase Chain Reaction (PCR) AssayUltraQual HIV-1 RT-PCR AssayNational Genetics Institute
Human Papillomavirus 9-valent Vaccine, RecombinantGARDASIL 9Merck & Co., INC
Human Papillomavirus (HPV)(Types 6, 11, 16, 18)Recombinant VaccineGARDASILMerck & Co, Inc
Human Papillomavirus (HPV) (Types 16 and 18)CervarixGlaxoSmithKline Biologicals, UK
Human T-Lymphotropic Virus Types I & IIAvioq HTLV - I/II Microelisa SystemAvioq, Inc.
Human T-Lymphotropic Virus Types I & IIAbbott HTLV-I/HTLV-II EIAAbbott Laboratories
Human T-Lymphotropic Virus Types I & IIABBOTT PRISM HTLV-I/HTLV-IIAbbott Laboratories
Human T-Lymphotropic Virus Types I & IIMP Diagnostics HTLV Blot 2.4MP Biomedicals Asia Pacific Pte. LTD
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I  
idecabtagene vicleucelABECMACelgene Corporation, a Bristol-Myers Squibb Company
Immune Globulin (Human)GamaSTAN S/DGrifols Therapeutics Inc.
Immune Globulin Infusion 10% (Human) with Recombinant Human HyaluronidaseHYQVIABaxter Healthcare Corporation, Baxter BioScience
Immune Globulin Intravenous (Human)Carimune NF, NanofilteredCSL Behring AG
Immune Globulin Intravenous (Human)Flebogamma DIF 5%Instituto Grifols, SA
Immune Globulin Intravenous (Human)GammaplexBio Products Laboratory
Immune globulin intravenous, human-diraYIMMUGOBiotest AG
Immune Globulin Intravenous, human-ifasPANZYGAOctapharma Pharmazeutika Produktionsges.m.b.H.
Immune Globulin Intravenous, Human - slraASCENIVADMA Biologics, Inc.
immune globulin intravenous human-stwkALYGLOGC Biopharma Corp.
Immune Globulin Intravenous (Human) 5%OCTAGAMOCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography PurifiedGamunex-C, GammakedGrifols Therapeutics Inc
Immune Globulin Intravenous (Human)BIVIGAMADMA Biologics, Inc.
Immune Globulin Intravenous (Human), 10% LiquidPrivigenCSL Behring AG
Immune Globulin Intravenous (Human), 10% SolutionGammagard LiquidBaxter Healthcare Corp
Immune Globulin Subcutaneous (Human)HizentraCSL Behring AG
Immune Globulin Subcutaneous (Human)VivaglobinCSL Behring GmbH
Immune Globulin Subcutaneous (Human)CUTAQUIGOCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
Immune Globulin Subcutaneous, Human - klhw, 20%XEMBIFYGrifols Therapeutics LLC
Immune Globulin Subcutaneous (Human), 20% SolutionCUVITRUBaxalta US, Inc.
Immune Globulin Products (Animal-derived)CroFabProtherics, Inc
Immune Globulin Products (Animal-derived)AnascorpRare Disease Therapeutics, Inc.
Immune Globulin Products (Animal-derived)DigiFabProtherics Inc
Imugen Babesia microti Nucleic Acid Test (NAT)Babesia microti NAT/Babesia microti NAT for Blood ScreeningOxford Immunotec Ltd
Imugen Babesia microti Nucleic Acid Test (NAT)Babesia microti AFIA/Babesia microti AFIA for Blood Donor ScreeningOxford Immunotec Ltd
Influenza A (H1N1) 2009 Monovalent VaccineNone [Influenza A (H1N1) 2009 Monovalent Vaccine]

CSL Limited

ID Biomedical Corporation of Quebec

MedImmune LLC

Novartis Vaccines and Diagnostics Limited

Sanofi Pasteur, Inc.

Influenza A (H5N1) Virus Monovalent Vaccine, AdjuvantedAREPANRIXID Biomedical Corporation of Quebec
Influenza A (H5N1) Monovalent Vaccine, AdjuvantedAUDENZSeqirus Inc.
Influenza VaccineFlublokProtein Sciences Corporation
Influenza VaccineFlublok QuadrivalentProtein Sciences Corporation
Influenza Vaccine, AdjuvantedFLUADSeqirus, Inc.
Influenza Vaccine, AdjuvantedFLUAD QUADRIVALENTSeqirus, Inc.
Influenza Virus VaccineAfluria, Afluria Southern HemisphereSeqirus Pty. Ltd.
Influenza Virus VaccineAfluria Quadrivalent, Afluria Quadrivalent Southern HemisphereSeqirus Pty Ltd.
Influenza Virus VaccineAgrifluNovartis Vaccines and Diagnostics, Inc.
Influenza Virus VaccineFluarixGlaxoSmithKline Biologicals
Influenza Virus VaccineFluarix QuadrivalentGlaxoSmithKline Biologicals
Influenza Virus VaccineFlucelvaxSeqirus, Inc.
Influenza Virus VaccineFlucelvax QuadrivalentSeqirus, Inc.
Influenza Virus VaccineFluLavalID Biomedical Corporation of Quebec
Influenza Virus VaccineFluLaval QuadrivalentID Biomedical Corporation of Quebec
Influenza Virus VaccineFluvirinSeqirus Vaccines Limited
Influenza Virus VaccineFluzone, Fluzone High-Dose and Fluzone IntradermalSanofi Pasteur, Inc
Influenza Virus VaccineFluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere, Fluzone High-Dose Quadrivalent Southern HemisphereSanofi Pasteur, Inc.
Influenza Virus Vaccine, H5N1 (for National Stockpile)None [Influenza Virus Vaccine, H5N1]Sanofi Pasteur, Inc
Influenza Virus Vaccine, H5N1 (for National Stockpile)Influenza A (H5N1) Virus Monovalent Vaccine, AdjuvantedID Biomedical Corporation of Quebec
Influenza Virus Vaccine, Live, IntranasalFluMistMedImmune Vaccines, Inc
Influenza Virus Vaccine, Live, IntranasalFluMist QuadrivalentMedImmune LLC
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J  
Japanese Encephalitis Vaccine, Inactivated, AdsorbedIXIAROIntercell Biomedical
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L  
lifileucelAMTAGVIIovance Biotherapeutics, Inc.
Lymphocyte Immune Globulin, Anti-thymocyte Globulin (Equine)ATGAMPharmacia & Upjohn Company LLC (a Pfizer Company)
lisocabtagene maraleucelBREYANZIJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
lovotibeglogene autotemcel (lovo-cel)LYFGENIAbluebird bio, Inc.
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M  
Measles, Mumps and Rubella Vaccine, LivePRIORIXGlaxoSmithKline Biologicals SA
Measles, Mumps and Rubella Virus Vaccine, LiveM-M-R IIMerck & Co, Inc
Measles, Mumps, Rubella and Varicella Virus Vaccine LiveProQuadMerck & Co, Inc
Meningococcal Group B VaccineTRUMENBAWyeth Pharmaceuticals, LLC, a subsidiary of Pfizer Inc.
Meningococcal Group B VaccineBexseroNovartis Vaccines and Diagnostics, Inc.
Meningococcal Groups A, B, C, W and Y VaccinePENBRAYAPfizer Ireland Pharmaceuticals
Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate VaccineMenveoNovartis Vaccines and Diagnostics, Inc.
Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate VaccineMenactraSanofi Pasteur, Inc
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate VaccineMenHibrixGlaxoSmithKline Biologicals
Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W-135 CombinedMenomune-A/C/Y/W-135Sanofi Pasteur, Inc
Meningococcal (Groups A, C, Y, W) Conjugate VaccineMenQuadfiSanofi Pasteur, Inc.
Multiple Non-standardized Allergenic ExtractsAllergenic ExtractsALK-Abello, Inc
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N  
nadofaragene firadenovecADSTILADRINFerring Pharmaceuticals A/S
Non-Standardized Allergenic ExtractsNoneJubilant HollisterStier LLC
Non-Standardized Allergenic ExtractsNoneGREER Laboratories, Inc.
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O  
obecabtagene autoleucelAUCATZYLAutolus Limited
NoneOraSure HIV-1 Oral Specimen Collection DeviceOraSure Technologies, Inc.
OLYMPUS PK System Blood Grouping and Phenotyping Reagents[OLYMPUS PK System Blood Grouping and Phenotyping Reagents]DIAGAST
omidubicel-onlvOMISIRGEGamida Cell Ltd.
onasemnogene abeparvovec-xioiZOLGENSMANovartis Gene Therapies, Inc.
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P  
Peanut (Arachis hypogaea) Allergen Powder-dnfpPALFORZIAAimmune Therapeutics, Inc.
Plasma Cryoprecipitate (For Further Manufacturing Use)Plasma CryoprecipitateOCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
Plasminogen, Human-tvmhRYPLAZIMPrometic Biotherapeutics Inc.
Pneumococcal Vaccine, PolyvalentPneumovax 23Merck &Co, Inc
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)PrevnarWyeth Pharmaceuticals, Inc
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)Prevnar 13Wyeth Pharmaceuticals, Inc
Pneumococcal 15-valent Conjugate VaccineVAXNEUVANCEMerck Sharp & Dohme Corp.
Pneumococcal 20-valent Conjugate VaccinePrevnar 20Wyeth Pharmaceuticals, LLC
Pneumococcal 21-valent Conjugate VaccineCAPVAXIVEMerck Sharp & Dohme LLC
Poliovirus Vaccine Inactivated (Monkey Kidney Cell)IPOLSanofi Pasteur, SA
Pooled Plasma (Human), Solvent/Detergent TreatedOctaplasOctapharma Pharmazeutika Produktionsges.m.b.H.
Procleix Babesia AssayProcleix Babesia AssayGrifols Diagnostic Solutions, Inc.
Procleix Ultrio Elite AssayProcleixGrifols Diagnostic Solutions, Inc.
Procleix Zika Virus AssayNONEGrifols Diagnostic Solutions, Inc.
Protein C Concentrate (Human)CEPROTINBaxter Healthcare Corp
Prothrombin Complex Concentrate (Human)KcentraCSL Behring GmbH
Prothrombin complex concentrate, human-lansBALFAXAROctapharma Pharmazeutika Produktionsges.m.b.H.
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R  
NoneRECELL Autologous Cell Harvesting Device (Model Number: AVRL0102)Avita Medical Americas, LLC
NoneRECELL Autologous Cell Harvesting DeviceAvita Medical Americas, LLC
Rabies Immune Globulin (Human)KEDRABKamada Ltd.
Rabies VaccineIMOVAX RABIESSanofi Pasteur
Rabies VaccineRabAvertNovartis Vaccines and Diagnostics
Respiratory Syncytial Virus VaccineABRYSVOPfizer Inc.
Respiratory Syncytial Virus Vaccine, AdjuvantedAREXVYGlaxoSmithKline Biologicals SA
Reagent Red Blood CellsREFERENCELLSImmucor, Inc.
Reagent Red Blood CellsALBAcyteAlba Bioscience Limited
Reagent Red Blood CellsData-Cyte Plus, Reverse-Cyte, Search-Cyte Reagent Red Blood Cells - STN 103898Medion Diagnostics AG
Reagent Red Blood CellsPanoscreen and Panoscreen EXTENDImmucor, Inc
Reagent Red Blood Cells; Reagent Red Blood Cells For Use in Automated SystemsBiotestcell and ErytypecellBiotest Medical Diagnostics GmbH
Reagent Red Blood Cells for use with the IH-SystemAnti-Human Globulin Anti-IgG IH-Card AHG Anti-IgGBio-Rad Medical Diagnostics GmbH
Remestemcel-L-rkndRYONCILMesoblast, Inc.
Respiratory Syncytial Virus VaccineMRESVIAModernaTX, Inc.
Rho(D) Immune Globulin Intravenous (Human)RhophylacCSL Behring AG
Rho(D) Immune Globulin Intravenous (Human)WinRho SDF LiquidCangene Corp
Rotavirus Vaccine, Live, OralROTARIXGlaxoSmithKline Biologicals
Rotavirus Vaccine, Live, Oral, PentavalentRotaTeqMerck & Co, Inc
Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch TestRubber Panel T.R.U.E. TESTSmartPractice Denmark ApS
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S  
Selective Cytopheretic DeviceQUELIMMUNESeaStar Medical, Inc.
Short Ragweed Pollen Allergenic Extract/ Short and Giant Ragweed Pollen Mix Allergenic ExtractNoneGreer Laboratories, Inc 
Short Ragweed Pollen Allergen ExtractRAGWITEKMerck Sharp & Dohme Corp
sipuleucel-TPROVENGEDendreon Corporation
Smallpox (Vaccinia) Vaccine, LiveACAM2000Emergent Product Development Gaithersburg, Inc.
Smallpox and Monkeypox Vaccine, Live, Non-ReplicatingJYNNEOSBavarian Nordic A/S
Standardized Grass Pollen Allergenic ExtractsNoneGreer Laboratories, Inc.
Standardized Short Ragweed (Ambrosia artemisiifolia) Allergenic ExtractStandardized Short RagweedJubilant HollisterStier LLC
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T  
Test, HIV Detection (Human Immunodeficiency Virus (HIV) p24 antigen and Antibodies to HIV Type 1 (HIV-1 group M and group O) and/or Type 2)LIAISON XL MUREX HIV Ab/Ag HT and LIAISON XL MUREX Control HIV Ab/Ag HTDiaSorin, Inc.
talimogene laherparepvecIMLYGICAmgen Inc.
Tetanus and Diphtheria Toxoids Adsorbed for Adult UseTENIVACSanofi Pasteur, Ltd
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, AdsorbedAdacelSanofi Pasteur, Ltd
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, AdsorbedBoostrixGlaxoSmithKline Biologicals
Thin-Layer Rapid Use Epicutaneous Patch TestT.R.U.E. TESTMekos Laboratories AS
Thrombin, Topical (Human)EvithromOMRIX Biopharmaceuticals, Ltd
Thrombin, Topical (Recombinant)RECOTHROMZymoGenetics, Inc
Thrombin, Topical (Bovine Origin)THROMBIN-JMIDistributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Manufactured by: GenTrac, Incorporated, Middleton, Wisconsin 53562
Tick-Borne Encephalitis VaccineTICOVACPfizer Ireland Pharmaceuticals
tisagenlecleucelKYMRIAHNovartis Pharmaceuticals Corporation
Trypanosoma cruzi (T. cruzi) (Anti-T. cruzi Assay)ABBOTT PRISM ChagasAbbott Laboratories
Trypanosoma cruzi (T.cruzi) Whole Cell Lysate AntigenORTHO T.cruzi ELISA Test SystemOrtho-Clinical Diagnostics, Inc
Trypanosoma Cruzi (T. cruzi) (E. Coli, Recombinant)ABBOTT ESA ChagasAbbott Laboratories
Trypanosoma Cruzi (E Coli, Recombinant) AntigenAlinity s ChagasAbbott GMBH & CO. KG
Tuberculin, Purified Protein DerivativeAplisolJHP Pharmaceuticals, LLC
Tuberculin, Purified Protein DerivativeTubersolSanofi Pasteur, Ltd
Typhoid Vaccine Live Oral Ty21aVivotifBerna Biotech, Ltd
Typhoid Vi Polysaccharide VaccineTyphim ViSanofi Pasteur, SA
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V  
Vaccinia Immune Globulin Intravenous (Human)NoneCangene Corp.
valoctocogene roxaparvovec-rvoxROCTAVIANBioMarin Pharmaceutical Inc
Varicella Virus Vaccine LiveVarivaxMerck & Co, Inc
Varicella Zoster Immune Globulin (Human)VARIZIGCangene Corporation
voretigene neparvovec-rzylLUXTURNASpark Therapeutics, Inc.
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W  
von Willebrand Factor/Coagulation Factor VIII Complex (Human)WilateOctapharma Pharmazeutika Produktionsges.m.b.H.
von Willebrand factor (Recombinant)VONVENDIBaxalta US Inc.
West Nile Virus Nucleic acid test for use in the cobas 6800/8800 Systemscobas WNVRoche Molecular System, Inc.
West Nile Virus (WNV) RNAcobas TaqScreen West Nile Virus Test for use with the cobas s 201 systemRoche Molecular System, Inc
West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic)Procleix West Nile Virus (WNV) AssayGen-Probe, Inc
Whole Blood and blood components (Convalescent Plasma, High Titer, Anti-SARS-CoV-2 (Whole Blood-derived) and Apheresis Convalescent Plasma, High Titer, Anti-SARS-CoV-2)N/AOneBlood, Inc.
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Y  
Yellow Fever VaccineYF-VaxSanofi Pasteur, Inc
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Z  
Zoster VaccineZostavaxMerck & Co, Inc
Zoster Vaccine Recombinant, AdjuvantedSHINGRIXGlaxoSmithKline Biologicals

 

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