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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
Product Trade Name Manufacturer
A    
None Aptima HIV-1 Quant Dx Assay Hologic, Inc.
None Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Barr Labs, Inc.
ADAMTS13, recombinant-krhn ADZYNMA Takeda Pharmaceuticals U.S.A., Inc.
afamitresgene autoleucel TECELRA Adaptimmune LLC
Anthrax Vaccine Adsorbed, Adjuvanted CYFENDUS Emergent Product Development Gaitherburg, Inc.
antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl ALTUVIIIO Bioverativ Therapeutics Inc., a Sanofi Company
ALBAclone® Anti-Fyb (Human/Murine Monoclonal) ALBAclone Anti-Fyb (Human/Murine Monoclonal) Alba Bioscience Limited
Albumin ALBUMINEX Bio Products Laboratory, USA
Albumin Albumin (Human) (None) Octapharma Pharmazeutika Produktionsgesm.b.H
Albumin  Kedbumin Kedrion Biopharmaceuticals, SpA
Allergen Extract Sublingual Tablets GRASTEK Merck Sharp & Dohme Corp
Allergen Extract Sublingual Tablets ODACTRA Merck Sharp & Dohme Corp
Allergen Extract Sublingual Tablets ORALAIR Stallergenes S.A.
Allergen Extract Sublingual Tablets RAGWITEK Merck Sharp & Dohme Corp
Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen GINTUIT Organogenesis Incorporated
allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen- dsat STRATAGRAFT Stratatech Corporation
allogeneic processed thymus tissue-agdc RETHYMIC Enzyvant Therapeutics GmbH
Alpha1-Proteinase Inhibitor (Human) Aralast NP Baxter Healthcare Corporation
Alpha1-Proteinase Inhibitor (Human) Aralast Baxter Healthcare Corporation
Alpha1-Proteinase Inhibitor (Human) GLASSIA Kamada Ltd.
Alpha1-Proteinase Inhibitor (Human) Prolastin Talecris Biotherapeutics, Inc.
Alpha1-Proteinase Inhibitor (Human) Prolastin-C Talecris Biotherapeutics, Inc.
Alpha1-Proteinase Inhibitor (Human) Zemaira Aventis Behring L.L.C.
None Alinity m HIV-1 Abbott Molecular, Inc
Anthrax Immune globulin Intravenous Anthrasil Cangene Corporation
Anthrax Vaccine Adsorbed Biothrax Emergent 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 3.0 Bio-Rad Laboratories
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal)Enzyme Immuno Assay (EIA)/Monoclonal) Auszyme Monoclonal Abbott Laboratories
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM); Antibody to Hepatitis B Surface Antigen (Human) ABBOTT PRISM HBsAg; ABBOTT PRISM HBsAg Confirmatory Abbott 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 Confirmatory Abbott Ireland Diagnostics Division
Antihemophilic Factor (Recombinant) Kogenate FS Bayer Corp
Antihemophilic Factor (Recombinant) KOVALTRY Bayer HealthCare LLC
Antihemophilic Factor (Recombinant) ReFacto Genetics Institute, Inc
Antihemophilic Factor (Recombinant) Recombinate Baxter Healthcare Corporation
Antihemophilic Factor (Recombinant) Novoeight Novo Nordisk
Antihemophilic Factor (Recombinant) NUWIQ Octapharma USA, Inc
Antihemophilic (Recombinant), FcFusion Protein ELOCTATE Biogen Idec, Inc.
Antihemophilic Factor (Recombinant), GlycoPEGylated-exei Esperoct Novo Nordisk, Inc.
Antihemophilic Factor (Recombinant), PEGylated ADYNOVATE Takeda Pharmaceuticals U.S.A., Inc.
Antihemophilic Factor (Recombinant), PEGylated-aucl JIVI Bayer Healthcare, Inc
Antihemophilic Factor (Recombinant), Plasma/Albumin Free XYNTHA Wyeth Pharmaceuticals, Inc
Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method Advate Baxter Healthcare Corp
Antihemophilic Factor (Recombinant), Porcine Sequence OBIZUR Baxter Healthcare Corporation
Antihemophilic Factor (Recombinant), Single Chain AFSTYLA CSL Behring, LLC
Antihemophilic Factor/von Willebrand Factor Complex (Human) Humate-P CSL Behring GmbH
Antihemophilic Factor/von Willebrand Factor Complex (Human) Alphanate Grifols Biologicals, Inc
Anti-Human Globulin Anti-Human Globulin Solidscreen II Biotest AG
Anti-Human Globulin Anti-Human Globulin (Formulated for Automated Testing) Bio-Rad Medical Diagnostics GmbH
Anti-Human Globulin Anti-Human Globulin (Rabbit/Murine Monoclonal) (Formulated for Automated Testing) Bio-Rad Medical Diagnostics GmbH
Anti-Human Globulin MTS Anti-IgG Card Micro 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 Monoclonal Diagast
Anti-Human Globulin (Rabbit/Murine Monoclonal) (For Further Manufacturing Use) Anti-Human Globulin Anti-IgG, -C3d FFMU, Rabbit Polyclonal/Murine Monoclonal Diagast
Anti-Inhibitor Coagulant Complex FEIBA Baxter Healthcare Corp
Antithrombin (Recombinant) ATryn GTC Biotherapeutics, Inc
Anti-thymocyte Globulin (Rabbit) Thymoglobulin Genzyme Corp
atidarsagene autotemcel LENMELDY Orchard Therapeutics (Europe) Limited
Autologous Cultured Chondrocytes MACI Vericel Corporation
axicabtagene ciloleucel YESCARTA Kite Pharma Inc.
Azficel-T LAVIV Fibrocell Technologies, Inc.
Return to A - Z List    
B    
BCG Live BCG Vaccine Organon Teknika Corp
BCG Live TICE BCG Organon Teknika Corp
beremagene geperpavec VYJUVEK Krystal Biotech, Inc.
betibeglogene autotemcel ZYNTEGLO bluebird 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 Reagents Blood Grouping Reagent, Anti-A (Murine Monoclonal) (FFMU) STN# 125669 & 125680 Diagast
Blood Grouping Reagents Blood 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/A Millipore (UK) Ltd.
Blood Grouping Reagent, Anti-Leb (Murine Monoclonal)(For Further Manufacturing Use) N/A Millipore (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) Card Micro Typing Systems
Blood Grouping Reagent Blood Grouping Reagent, Anti-Fyb (Monoclonal) Immucor, Inc.
Blood Grouping Reagent Blood Grouping Reagent, Anti-Cw (Monoclonal) Immucor, Inc.
Blood Grouping Reagent Blood Grouping Reagent, Anti-k (Monoclonal) Immucor, Inc.
Blood Grouping Reagents Anti-Fya (Murine Monoclonal) (Recombinant) Siwa Biotech Corp.
Blood Grouping Reagents Anti-Fyb (Murine Monoclonal) (Recombinant) Siwa Biotech Corp.
Blood Grouping Reagents ALBAclone Alba Bioscience, Inc
Blood Grouping Reagents Blood Grouping Reagents, Anti-Fya, Anti-Jka, Anti-Jkb, Anti-S, Anti-s, Anti-K, Anti-P1 Alba Bioscience Limited
Blood Grouping Reagents Blood Grouping Regents, BL 101728-34;103292 American National Red Cross
Blood Grouping Reagents ORTHO Sera Alba Bioscience Limted
Blood Grouping Reagents ORTHO Sera Anti-D (IAT) (Monoclonal Blend) Blood Grouping Reagent Alba Bioscience Limited (Alba)
Blood Grouping Reagents Diagast Bundled BLA 125615, 125619 to 125626 Diagast
Blood Grouping Reagent Component of Erytype S Biotest Medical Diagnostics GmbH
Blood Grouping Reagent Erytype S Biotest Medical Diagnostics GmbH
Blood Grouping Reagent MTS 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 Reagent 0.8% SELECTOGEN; 0.8% SURGISCREEN; 0.8% AFFIRMAGEN; 0.8% RESOLVE PANELS A, B, C; 0.8% POOLING SCREENING CELLS Ortho-Clinical Diagnostics, Inc.
Blood Grouping Reagents (ALBAsera) Anti-Fya ALBAsera Alba Bioscience Limited
Blood Grouping Reagents (ALBAsera) Anti-Fyb ALBAsera Alba Bioscience Limited
Blood Grouping Reagents (ALBAsera) Anti-Wra ALBAsera Alba Bioscience Limited
Blood Grouping Reagents (ALBAsera) Anti-s ALBAsera Alba Bioscience Limited
Blood Grouping Reagents (ALBAsera) Anti-K ALBAsera Alba 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) Seraclone Biotest Medical Diagnostics GmbH
Blood Grouping Reagent Anti-S (Monoclonal) Seraclone Biotest Medical Diagnostics GmbH
Blood Grouping Reagents and Anti-Human Globulin Reagents Seraclone Blood Grouping Reagents and Anti-Human Globulin Reagents (STN# 125213, 125215, 125217, 125219 - 125233, 125242) Biotest Medical Diagnostics GmbH
Blood Grouping Reagent Combination Kit DG Gel Card 125445, 125449, 125450 - 125457 Diagnostic Grifols, S. A.
Blood Grouping Reagent Combination Kit Micro Typing System A/B; MTS A/B/D; MTS A/B/D/Reverse and MTS Monoclonal Rh Phenotype Card Micro Typing Systems, Inc
Blood Grouping Reagent (Human/Murine Monoclonal) Anti-C, Anti-e, Anti-Cw Alba Bioscience Limited
Botulism Immune Globulin Intravenous (Human) BabyBIG California Department of Health Services
brexucabtagene autoleucel TECARTUS Kite 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, Live IXCHIQ Valneva Austria GmbH
ciltacabtagene autoleucel CARVYKTI Janssen Biotech, Inc.
C1 Esterase Inhibitor (Human) Berinert CSL Behring GmbH
C1 Esterase Inhibitor (Human) Cinryze Lev Pharmaceuticals, Inc
C1 Esterase Inhibitor (Human) HAEGARDA CSL Behring GmbH
C1 Esterase Inhibitor
(Recombinant)
RUCONEST Salix Pharmaceuticals, Inc.
Candida albicans Skin Test Antigen For Cellular Hypersensitivity CANDIN Nielson BioSciences Inc.
Cholera Vaccine, Live, Oral VAXCHORA Pax Vax Bermuda Ltd.
Coagulation Factor VIIa (Recombinant) NovoSeven NovoNordisk, Inc
Coagulation Factor VIIa (Recombinant) NovoSevenRT NovoNordisk, Inc
Coagulation Factor IX (Recombinant) ALPROLIX Bioverativ Therapeutics, Inc.
Coagulation Factor IX (Recombinant) Benefix Wyeth Pharmaceuticals
Coagulation Factor IX (Recombinant) IXINITY Medexus Pharma, Inc.
Coagulation Factor IX (Recombinant) RIXUBIS Baxter Healthcare Corporation
Coagulation Factor IX (Recombinant), Albumin Fusion Protein IDELVION CSL Behring Recombinant Facility AG
Coagulation Factor IX (Recombinant), GlycoPEGylated REBINYN Novo Nordisk Inc.
Coagulation Factor X (Human) COAGADEX Bio Products Laboratory USA, Inc.
coagulation factor Xa (recombinant), inactivated-zhzo ANDEXXA Portola Pharmaceuticals, Inc.
Coagulation Factor XIII A-Subunit (Recombinant) TRETTEN Novo Nordisk, Inc
coagulation factor Vlla (recombinant)-jncw SEVENFACT Laboratoire Francais du Fractionnement et des Biotechnologies S.A. (LFB S.A)
None cobas HIV-1/HIV-2 Qualitative Roche Molecular Systems, Inc.
cobas® Zika, Nucleic acid test for use on the cobas® 6800/8800 systems cobas Zika Roche Molecular Systems, Inc
cobas® Babesia test for use on the cobas® 6800/8800 Systems cobas Babesia Roche Molecular Systems, Inc.
cobas® Malaria test for use on the cobas® 6800/8800 Systems cobas® Malaria Roche Molecular Systems
Coccidioides immitis Spherule - Derived Skin Test Antigen Spherusol Allermed Laboratories, Inc.
COVID-19 Vaccine mRNA Comirnaty BioNTech Manufacturing GmbH
COVID-19 Vaccine, mRNA SPIKEVAX ModernaTx, Inc
Crotalidae Immune F(ab’)2 (Equine) ANAVIP Instituto Bioclon, S.A. de C.V.
Cytomegalovirus Immune Globulin Intravenous (Human) CytoGam CSL Behring LLC
Return to A - Z List    
D    
delandistrogene moxeparvovec-rokl ELEVIDYS Sarepta Therapeutics, Inc.
None DPP HIV-Syphilis System Chembio Diagnostic Systems, Inc.
Dermatophagoides pteronyssinus Standardized Mite Extract Jubiliant HollisterStier LLC
Dermatophagoides farinae Standardized Mite Extract Jubiliant HollisterStier LLC
DENGUE Tetravalent Vaccine, Live DENGVAXIA Sanofi Pasteur, Inc.
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed DAPTACEL Sanofi Pasteur, Ltd
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed INFANRIX GlaxoSmithKline Biologicals
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined Pediarix GlaxoSmithKline Biologicals
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine KINRIX GlaxoSmithKline Biologicals
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine Quadracel Sanofi Pasteur Limited
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Pentacel Sanofi Pasteur, Ltd
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine VAXELIS MCM Vaccine Company
donislecel LANTIDRA CellTrans Inc.
Return to A - Z List    
E    
Elecsys Anti-HBc II Elecsys Anti-HBc II Roche Diagnostics
Elecsys Anti-HCV II Elecsys Anti-HCV II Roche Diagnostics
Elecsys Chagas Elecsys Chagas Roche Diagnostics
Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm Roche Diagnostics
Elecsys HIV Duo Elecsys HIV Duo Roche Diagnostics
Elecsys HIV Duo Elecsys HIV Duo Roche Diagnostics
Elecsys HTLV-I/II Elecsys HTLV-I/II Roche Diagnostics
Ebola Zaire Vaccine, Live ERVEBO Merck Sharp & Dohme LLC
elivaldogene autotemcel SKYSONA bluebird bio, Inc.
etranacogene dezaparvovec-drlb HEMGENIX CSL Behring LLC
exagamglogene Autotemcel (exa-cel) CASGEVY Vertex Pharmaceuticals Incorporated
Return to A - Z List    
F    
Factor IX Complex Profilnine SD Grifols Biologicals Inc.
Factor XIII Concentrate (Human) Corifact CSL Behring. GmbH
fecal microbiota spores, live-brpk VOWST Seres Therapeutics, Inc.
fecal microbiota, live-jslm REBYOTA Ferring Pharmaceuticals Inc.
Fidanacogene elaparvovec-dzkt BEQVEZ Pfizer, Inc.
Fibrin Sealants Topical VISTASEAL Instituto Grifols, S.A.
Fibrin Sealants Topical RAPLIXA The Medicines Company
Fibrin Sealants Topical TISSEEL Baxter Healthcare Corp
Fibrin Sealants Topical ARTISS Baxter Healthcare Corp
Fibrin Sealants Topical Evicel Omrix Biopharmaceuticals, Ltd
Fibrin Sealant Patch, Absorbable EVARREST Ethicon, Inc
Fibrin Sealant Patch, Absorbable TachoSil Nycomed Danmark ApS
Fibrinogen (Human) FIBRYGA Octapharma Pharmazeutika Produktionsges.m.b.H.
Fibrinogen Concentrate (Human) RIASTAP CSL Behring GmbH
Return to A - Z List    
H    
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine COMVAX (Discontinued) Merck &Co, Inc
Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate) PedvaxHIB Merck Sharp & Dohme Corp.
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) Hiberix GlaxoSmithKline Biologicals, S.A.
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) ActHIB Sanofi Pasteur, SA
Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine TWINRIX GlaxoSmithKline Biologicals
Hepatitis A Vaccine, Inactivated Havrix GlaxoSmithKline Biologicals
Hepatitis A Vaccine, Inactivated VAQTA Merck Co, Inc
Hepatitis B Immune Globulin (Human) Nabi-HB Nabi Biopharmaceuticals
Hepatitis B Immune Globulin Intravenous (Human) HepaGam B Cangene Corp
Hepatitis B Vaccine (Recombinant) Recombivax HB Merck Co, Inc
Hepatitis B Vaccine (Recombinant) ENGERIX-B GlaxoSmithKline Biologicals
Hepatitis B Vaccine (Recombinant) PREHEVBRIO VBI Vaccines (Delaware) Inc.
Hepatitis B Vaccine (Recombinant), Adjuvanted HEPLISAV-B Dynavax Technologies Corporation
Hepatitis B Virus Core Antigen (E.coli, Recombinant) ABBOTT PRISM HBcore Abbott Laboratories
Hepatitis B Virus Core Antigen (E. coli, Recombinant) Alinity s Anti-HBc Abbott GmbH & Co. KG
Hepatitis B Virus (Hepatitis B Virus/Polymerase Chain Reaction/Blood Cell Derived) COBAS AmpliScreen HBV Test Roche Molecular Systems, Inc
Hepatitis C Virus (E coli, Recombinant) NS3 Helicase Antigens and Synthetic Core Peptide Alinity s Anti-HCV II assay Abbott GmbH
Hepatitis C Virus (Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived) COBAS AmpliScreen HCV Test, version 2.0 Roche Molecular Systems, Inc
Hepatitis C Virus Encoded Antigen (HCV Encoded Antigen/Enzyme Immuno Assay (EIA)/Recombinant) ABBOTT HCV EIA 2.0 Abbott 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 System Ortho-Clinical Diagnostics, Inc.
Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43, NS5) ABBOTT PRISM HCV Abbott Laboratories
Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43) Alinity s Anti-HCV Abbott GmBH & Co. KG
Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic) (RIBA) CHIRON RIBA HCV 3.0 Strip Immunoblot Assay Novartis Vaccines and Diagnostics, Inc
Hepatitis C Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay UltraQual HCV-RT-PCR-Assay National Genetics Institute
Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay None [Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay] BioLife Plasma Services, LP
HPC, Cord Blood ALLOCORD SSM Cardinal Glennon Children's Medical Center
HPC, Cord Blood Clevecord Cleveland Cord Blood Center
HPC, Cord Blood Ducord Duke University School of Medicine, Carolinas
HPC, Cord Blood Hemacord New York Blood Center, Inc
HPC, Cord Blood None [HPC, Cord Blood] Bloodworks
HPC, Cord Blood None [HPC, Cord Blood] Clinimmune Labs, University of Colorado Cord Blood Bank
HPC, Cord Blood None [HPC, Cord Blood] LifeSouth Community Blood Centers, Inc.
HPC, Cord Blood None [HPC, Cord Blood] MD Anderson Cord Blood Bank
HIV Supplemental Assay VioOne HIV Profile Supplemental Assay Avioq, Inc.
Human Immunodeficiency Virus Type I Genetic Systems rLAV EIA Bio-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 Assay Gen-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 system Roche 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 Assay COBAS TaqScreen MPX Test Roche 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 Assay Gen-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 Assays Gen-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 Assay Gen-Probe, Inc
Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay None [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 Plus Abbott Park, IL
Human Immunodeficiency Virus Types 1 and 2 (E coli, B megaterium, Recombinant) Antigen, Antibody (p24) and Synthetic Peptides Alinity s HIV Ag/Ab Combo Reagent Kit Abbott GmbH & Co. KG
Human T-Lymphotropic Virus Types I and II (E coli, Recombinant) Antigen and Synthetic Peptides Alinity s HTLV I/II Abbott GmbH & Co. KG
Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptides) Geenius HIV 1/2 Supplemental Assay Bio-Rad Laboratories, Inc.
Human Immunodeficiency Virus Types 1 and 2/Enzyme Immuno Assay (EIA) / Recombinant) HIVAB HIV-1/HIV-2 (rDNA) EIA Abbott 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 EIA Bio-Rad Laboratories
Human Immunodeficiency Virus Type 1 Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay UltraQual HIV-1 RT-PCR Assay National Genetics Institute
Human Papillomavirus 9-valent Vaccine, Recombinant GARDASIL 9 Merck & Co., INC
Human Papillomavirus (HPV)(Types 6, 11, 16, 18)Recombinant Vaccine GARDASIL Merck & Co, Inc
Human Papillomavirus (HPV) (Types 16 and 18) Cervarix GlaxoSmithKline Biologicals, UK
Human T-Lymphotropic Virus Types I & II Avioq HTLV - I/II Microelisa System Avioq, Inc.
Human T-Lymphotropic Virus Types I & II Abbott HTLV-I/HTLV-II EIA Abbott Laboratories
Human T-Lymphotropic Virus Types I & II ABBOTT PRISM HTLV-I/HTLV-II Abbott Laboratories
Human T-Lymphotropic Virus Types I & II MP Diagnostics HTLV Blot 2.4 MP Biomedicals Asia Pacific Pte. LTD
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I    
idecabtagene vicleucel ABECMA Celgene Corporation, a Bristol-Myers Squibb Company
Immune Globulin (Human) GamaSTAN S/D Grifols Therapeutics Inc.
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase HYQVIA Baxter Healthcare Corporation, Baxter BioScience
Immune Globulin Intravenous (Human) Carimune NF, Nanofiltered CSL Behring AG
Immune Globulin Intravenous (Human) Flebogamma DIF 5% Instituto Grifols, SA
Immune Globulin Intravenous (Human) Gammaplex Bio Products Laboratory
Immune globulin intravenous, human-dira YIMMUGO Biotest AG
Immune Globulin Intravenous, human-ifas PANZYGA Octapharma Pharmazeutika Produktionsges.m.b.H.
Immune Globulin Intravenous, Human - slra ASCENIV ADMA Biologics, Inc.
immune globulin intravenous human-stwk ALYGLO GC Biopharma Corp.
Immune Globulin Intravenous (Human) 5% OCTAGAM OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified Gamunex-C, Gammaked Grifols Therapeutics Inc
Immune Globulin Intravenous (Human) BIVIGAM ADMA Biologics, Inc.
Immune Globulin Intravenous (Human), 10% Liquid Privigen CSL Behring AG
Immune Globulin Intravenous (Human), 10% Solution Gammagard Liquid Baxter Healthcare Corp
Immune Globulin Subcutaneous (Human) Hizentra CSL Behring AG
Immune Globulin Subcutaneous (Human) Vivaglobin CSL Behring GmbH
Immune Globulin Subcutaneous (Human) CUTAQUIG OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
Immune Globulin Subcutaneous, Human - klhw, 20% XEMBIFY Grifols Therapeutics LLC
Immune Globulin Subcutaneous (Human), 20% Solution CUVITRU Baxalta US, Inc.
Immune Globulin Products (Animal-derived) CroFab Protherics, Inc
Immune Globulin Products (Animal-derived) Anascorp Rare Disease Therapeutics, Inc.
Immune Globulin Products (Animal-derived) DigiFab Protherics Inc
Imugen Babesia microti Nucleic Acid Test (NAT) Babesia microti NAT/Babesia microti NAT for Blood Screening Oxford Immunotec Ltd
Imugen Babesia microti Nucleic Acid Test (NAT) Babesia microti AFIA/Babesia microti AFIA for Blood Donor Screening Oxford Immunotec Ltd
Influenza A (H1N1) 2009 Monovalent Vaccine None [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) Monovalent Vaccine, Adjuvanted AUDENZ Seqirus Inc.
Influenza Vaccine Flublok Protein Sciences Corporation
Influenza Vaccine Flublok Quadrivalent Protein Sciences Corporation
Influenza Vaccine, Adjuvanted FLUAD Seqirus, Inc.
Influenza Vaccine, Adjuvanted FLUAD QUADRIVALENT Seqirus, Inc.
Influenza Virus Vaccine Afluria, Afluria Southern Hemisphere Seqirus Pty. Ltd.
Influenza Virus Vaccine Afluria Quadrivalent, Afluria Quadrivalent Southern Hemisphere Seqirus Pty Ltd.
Influenza Virus Vaccine Agriflu Novartis Vaccines and Diagnostics, Inc.
Influenza Virus Vaccine Fluarix GlaxoSmithKline Biologicals
Influenza Virus Vaccine Fluarix Quadrivalent GlaxoSmithKline Biologicals
Influenza Virus Vaccine Flucelvax Seqirus, Inc.
Influenza Virus Vaccine Flucelvax Quadrivalent Seqirus, Inc.
Influenza Virus Vaccine FluLaval ID Biomedical Corporation of Quebec
Influenza Virus Vaccine FluLaval Quadrivalent ID Biomedical Corporation of Quebec
Influenza Virus Vaccine Fluvirin Seqirus Vaccines Limited
Influenza Virus Vaccine Fluzone, Fluzone High-Dose and Fluzone Intradermal Sanofi Pasteur, Inc
Influenza Virus Vaccine

Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere, Fluzone High-Dose Quadrivalent Southern Hemisphere

Sanofi 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, Adjuvanted ID Biomedical Corporation of Quebec
Influenza Virus Vaccine, Live, Intranasal FluMist MedImmune Vaccines, Inc
Influenza Virus Vaccine, Live, Intranasal FluMist Quadrivalent MedImmune LLC
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J    
Japanese Encephalitis Vaccine, Inactivated, Adsorbed IXIARO Intercell Biomedical
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L    
lifileucel AMTAGVI Iovance Biotherapeutics, Inc.
Lymphocyte Immune Globulin, Anti-thymocyte Globulin (Equine) ATGAM Pharmacia & Upjohn Company LLC (a Pfizer Company)
lisocabtagene maraleucel BREYANZI Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
lovotibeglogene autotemcel (lovo-cel) LYFGENIA bluebird bio, Inc.
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M    
Measles, Mumps and Rubella Vaccine, Live PRIORIX GlaxoSmithKline Biologicals SA
Measles, Mumps and Rubella Virus Vaccine, Live M-M-R II Merck & Co, Inc
Measles, Mumps, Rubella and Varicella Virus Vaccine Live ProQuad Merck & Co, Inc
Meningococcal Group B Vaccine TRUMENBA Wyeth Pharmaceuticals, LLC, a subsidiary of Pfizer Inc.
Meningococcal Group B Vaccine Bexsero Novartis Vaccines and Diagnostics, Inc.
Meningococcal Groups A, B, C, W and Y Vaccine PENBRAYA Pfizer Ireland Pharmaceuticals
Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine Menveo Novartis Vaccines and Diagnostics, Inc.
Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Menactra Sanofi Pasteur, Inc
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine MenHibrix GlaxoSmithKline Biologicals
Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W-135 Combined Menomune-A/C/Y/W-135 Sanofi Pasteur, Inc
Meningococcal (Groups A, C, Y, W) Conjugate Vaccine MenQuadfi Sanofi Pasteur, Inc.
Multiple Non-standardized Allergenic Extracts Allergenic Extracts ALK-Abello, Inc
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N    
nadofaragene firadenovec ADSTILADRIN Ferring Pharmaceuticals A/S
Non-Standardized Allergenic Extracts None Jubilant HollisterStier LLC
Non-Standardized Allergenic Extracts None GREER Laboratories, Inc.
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O    
None OraSure HIV-1 Oral Specimen Collection Device OraSure Technologies, Inc.
OLYMPUS PK System Blood Grouping and Phenotyping Reagents [OLYMPUS PK System Blood Grouping and Phenotyping Reagents] DIAGAST
omidubicel-onlv OMISIRGE Gamida Cell Ltd.
onasemnogene abeparvovec-xioi ZOLGENSMA Novartis Gene Therapies, Inc.
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P    
Peanut (Arachis hypogaea) Allergen Powder-dnfp PALFORZIA Aimmune Therapeutics, Inc.
Plasma Cryoprecipitate (For Further Manufacturing Use) Plasma Cryoprecipitate OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
Plasminogen, Human-tvmh RYPLAZIM Prometic Biotherapeutics Inc.
Pneumococcal Vaccine, Polyvalent Pneumovax 23 Merck &Co, Inc
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Prevnar Wyeth Pharmaceuticals, Inc
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Prevnar 13 Wyeth Pharmaceuticals, Inc
Pneumococcal 15-valent Conjugate Vaccine VAXNEUVANCE Merck Sharp & Dohme Corp.
Pneumococcal 20-valent Conjugate Vaccine Prevnar 20 Wyeth Pharmaceuticals, LLC
Pneumococcal 21-valent Conjugate Vaccine CAPVAXIVE Merck Sharp & Dohme LLC
Poliovirus Vaccine Inactivated (Monkey Kidney Cell) IPOL Sanofi Pasteur, SA
Pooled Plasma (Human), Solvent/Detergent Treated Octaplas Octapharma Pharmazeutika Produktionsges.m.b.H.
Procleix Babesia Assay Procleix Babesia Assay Grifols Diagnostic Solutions, Inc.
Procleix Ultrio Elite Assay Procleix Grifols Diagnostic Solutions, Inc.
Procleix Zika Virus Assay NONE Grifols Diagnostic Solutions, Inc.
Protein C Concentrate (Human) CEPROTIN Baxter Healthcare Corp
Prothrombin Complex Concentrate (Human) Kcentra CSL Behring GmbH
Prothrombin complex concentrate, human-lans BALFAXAR Octapharma Pharmazeutika Produktionsges.m.b.H.
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R    
None RECELL Autologous Cell Harvesting Device (Model Number: AVRL0102) Avita Medical Americas, LLC
None RECELL Autologous Cell Harvesting Device Avita Medical Americas, LLC
Rabies Immune Globulin (Human) KEDRAB Kamada Ltd.
Rabies Vaccine IMOVAX RABIES Sanofi Pasteur
Rabies Vaccine RabAvert Novartis Vaccines and Diagnostics
Respiratory Syncytial Virus Vaccine ABRYSVO Pfizer Inc.
Respiratory Syncytial Virus Vaccine, Adjuvanted AREXVY GlaxoSmithKline Biologicals SA
Reagent Red Blood Cells REFERENCELLS Immucor, Inc.
Reagent Red Blood Cells ALBAcyte Alba Bioscience Limited
Reagent Red Blood Cells Data-Cyte Plus, Reverse-Cyte, Search-Cyte Reagent Red Blood Cells - STN 103898 Medion Diagnostics AG
Reagent Red Blood Cells Panoscreen and Panoscreen EXTEND Immucor, Inc
Reagent Red Blood Cells; Reagent Red Blood Cells For Use in Automated Systems Biotestcell and Erytypecell Biotest Medical Diagnostics GmbH
Reagent Red Blood Cells for use with the IH-System Anti-Human Globulin Anti-IgG IH-Card AHG Anti-IgG Bio-Rad Medical Diagnostics GmbH
Respiratory Syncytial Virus Vaccine MRESVIA ModernaTX, Inc.
Rho(D) Immune Globulin Intravenous (Human) Rhophylac CSL Behring AG
Rho(D) Immune Globulin Intravenous (Human) WinRho SDF Liquid Cangene Corp
Rotavirus Vaccine, Live, Oral ROTARIX GlaxoSmithKline Biologicals
Rotavirus Vaccine, Live, Oral, Pentavalent RotaTeq Merck & Co, Inc
Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test Rubber Panel T.R.U.E. TEST SmartPractice Denmark ApS
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S    
Selective Cytopheretic Device QUELIMMUNE SeaStar Medical, Inc.
Short Ragweed Pollen Allergenic Extract/ Short and Giant Ragweed Pollen Mix Allergenic Extract None Greer Laboratories, Inc 
Short Ragweed Pollen Allergen Extract RAGWITEK Merck Sharp & Dohme Corp
sipuleucel-T PROVENGE Dendreon Corporation
Smallpox (Vaccinia) Vaccine, Live ACAM2000 Emergent Product Development Gaithersburg, Inc.
Smallpox and Monkeypox Vaccine, Live, Non-Replicating JYNNEOS Bavarian Nordic A/S
Standardized Grass Pollen Allergenic Extracts None Greer Laboratories, Inc.
Standardized Short Ragweed (Ambrosia artemisiifolia) Allergenic Extract Standardized Short Ragweed Jubilant 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 HT DiaSorin, Inc.
talimogene laherparepvec IMLYGIC Amgen Inc.
Tetanus and Diphtheria Toxoids Adsorbed for Adult Use TENIVAC Sanofi Pasteur, Ltd
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed Adacel Sanofi Pasteur, Ltd
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed Boostrix GlaxoSmithKline Biologicals
Thin-Layer Rapid Use Epicutaneous Patch Test T.R.U.E. TEST Mekos Laboratories AS
Thrombin, Topical (Human) Evithrom OMRIX Biopharmaceuticals, Ltd
Thrombin, Topical (Recombinant) RECOTHROM ZymoGenetics, Inc
Thrombin, Topical (Bovine Origin) THROMBIN-JMI Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Manufactured by: GenTrac, Incorporated, Middleton, Wisconsin 53562
Tick-Borne Encephalitis Vaccine TICOVAC Pfizer Ireland Pharmaceuticals
tisagenlecleucel KYMRIAH Novartis Pharmaceuticals Corporation
Trypanosoma cruzi (T. cruzi) (Anti-T. cruzi Assay) ABBOTT PRISM Chagas Abbott Laboratories
Trypanosoma cruzi (T.cruzi) Whole Cell Lysate Antigen ORTHO T.cruzi ELISA Test System Ortho-Clinical Diagnostics, Inc
Trypanosoma Cruzi (T. cruzi) (E. Coli, Recombinant) ABBOTT ESA Chagas Abbott Laboratories
Trypanosoma Cruzi (E Coli, Recombinant) Antigen Alinity s Chagas Abbott GMBH & CO. KG
Tuberculin, Purified Protein Derivative Aplisol JHP Pharmaceuticals, LLC
Tuberculin, Purified Protein Derivative Tubersol Sanofi Pasteur, Ltd
Typhoid Vaccine Live Oral Ty21a Vivotif Berna Biotech, Ltd
Typhoid Vi Polysaccharide Vaccine Typhim Vi Sanofi Pasteur, SA
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V    
Vaccinia Immune Globulin Intravenous (Human) None Cangene Corp.
valoctocogene roxaparvovec-rvox ROCTAVIAN BioMarin Pharmaceutical Inc
Varicella Virus Vaccine Live Varivax Merck & Co, Inc
Varicella Zoster Immune Globulin (Human) VARIZIG Cangene Corporation
voretigene neparvovec-rzyl LUXTURNA Spark Therapeutics, Inc.
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W    
von Willebrand Factor/Coagulation Factor VIII Complex (Human) Wilate Octapharma Pharmazeutika Produktionsges.m.b.H.
von Willebrand factor (Recombinant) VONVENDI Baxalta US Inc.
West Nile Virus Nucleic acid test for use in the cobas 6800/8800 Systems cobas WNV Roche Molecular System, Inc.
West Nile Virus (WNV) RNA cobas TaqScreen West Nile Virus Test for use with the cobas s 201 system Roche Molecular System, Inc
West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic) Procleix West Nile Virus (WNV) Assay Gen-Probe, Inc
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Y    
Yellow Fever Vaccine YF-Vax Sanofi Pasteur, Inc
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Z    
Zoster Vaccine Zostavax Merck & Co, Inc
Zoster Vaccine Recombinant, Adjuvanted SHINGRIX GlaxoSmithKline Biologicals

 

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