Licensed Biological Products with Supporting Documents

A None Aptima HIV-1 Quant Dx Assay Hologic, Inc. None Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Barr Labs, Inc. ALBAclone® Anti-Fy^b (Human/Murine Monoclonal) ALBAclone Anti-Fy^b (Human/Murine Monoclonal) Alba Bioscience Limited
Albumin ALBUMINEX Bio Products Laboratory, USA Albumin (Human) (None) Octapharma Pharmazeutika Produktionsgesm.b.H Kedbumin Kedrion Biopharmaceuticals, SpA Allergen Extract Sublingual Tablets GRASTEK Merck Sharp & Dohme Corp ODACTRA Merck Sharp & Dohme Corp ORALAIR Stallergenes S.A. 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 Aralast Baxter Healthcare Corporation GLASSIA Kamada Ltd. Prolastin Talecris Biotherapeutics, Inc. Prolastin-C Talecris Biotherapeutics, Inc. 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 KOVALTRY Bayer HealthCare LLC ReFacto Genetics Institute, Inc Recombinate Baxter Healthcare Corporation Novoeight Novo Nordisk NUWIQ Octapharma USA, Inc Antihemophilic (Recombinant), FcFusion Protein ELOCTATE Biogen Idec, Inc. Antihemophilic Factor (Recombinant), PEGylated ADYNOVATE Baxalta US 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 Alphanate Grifols Biologicals, Inc Anti-Human Globulin Anti-Human Globulin Solidscreen II Biotest AG Anti-Human Globulin (Formulated for Automated Testing) Bio-Rad Medical Diagnostics GmbH 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 Autologous Cultured Chondrocytes MACI Vericel Corporation axicabtagene ciloleucel YESCARTA Kite Pharma Inc. Azficel-T LAVIV Fibrocell Technologies, Inc. Return to A - Z List) B betibeglogene autotemcel ZYNTEGLO bluebird bio Inc. BCG Live TICE BCG Organon Teknika Corp BCG Vaccine Organon Teknika Corp 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-Le^a (Murine Monoclonal)(For Further Manufacturing Use) N/A Millipore (UK) Ltd. Blood Grouping Reagent, Anti-Le^b (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-Fy^a ALBAsera Alba Bioscience Limited Anti-Fy^b ALBAsera Alba Bioscience Limited Anti-Wr^a ALBAsera Alba Bioscience Limited Anti-s ALBAsera Alba Bioscience Limited 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-Fy^a (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 ciltacabtagene autoleucel CARVYKTI Janssen Biotech, Inc. C1 Esterase Inhibitor (Human) Berinert CSL Behring GmbH Cinryze Lev Pharmaceuticals, Inc 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 NovoSevenRT NovoNordisk, Inc Coagulation Factor IX (Recombinant) ALPROLIX Bioverativ Therapeutics, Inc. Coagulation Factor IX (Recombinant) Benefix Wyeth Pharmaceuticals Coagulation Factor IX (Recombinant) IXINITY Cangene Corporation 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. 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 None DPP HIV-Syphilis System Chembio Diagnostic Systems, Inc. DENGUE Tetravalent Vaccine, Live DENGVAXIA Sanofi Pasteur, Inc. Diphtheria and Tetanus Toxoids Adsorbed, STN 103944 None [Diphtheria and Tetanus Toxoids Adsorbed] Sanofi Pasteur, Inc. Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed DAPTACEL Sanofi Pasteur, Ltd 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 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 Return to A - Z List E elivaldogene autotemcel SKYSONA bluebird bio, Inc. Elecsys HIV Duo Elecsys HIV Duo Roche Diagnostics Ebola Zaire Vaccine, Live ERVEBO Merck Sharp & Dohme Corp. Return to A - Z List F Factor IX Complex Profilnine SD Grifols Biologicals Inc. Factor XIII Concentrate (Human) Corifact CSL Behring. GmbH Fibrin Sealants Topical VISTASEAL Instituto Grifols, S.A. RAPLIXA The Medicines Company TISSEEL Baxter Healthcare Corp ARTISS Baxter Healthcare Corp Evicel Omrix Biopharmaceuticals, Ltd Fibrin Sealant Patch, Absorbable EVARREST Ethicon, Inc 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. ActHIB Sanofi Pasteur, SA Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine TWINRIX GlaxoSmithKline Biologicals Hepatitis A Vaccine, Inactivated Havrix GlaxoSmithKline Biologicals 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 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 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. Abbott HTLV-I/HTLV-II EIA Abbott Laboratories ABBOTT PRISM HTLV-I/HTLV-II Abbott Laboratories MP Diagnostics HTLV Blot 2.4 MP Biomedicals Asia Pacific Pte. LTD       Return to A - Z List 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 Flebogamma DIF 5% Instituto Grifols, SA Gammaplex Bio Products Laboratory Immune Globulin Intravenous, human-ifas PANZYGA Octapharma Pharmazeutika Produktionsges.m.b.H. Immune Globulin Intravenous (Human) 5% OCTAGAM OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.

Immune Globulin Intravenous, Human - slra 10% Liquid 

ASCENIV ADMA Biologics, Inc. Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified Gamunex-C Grifols Therapeutics Inc Immune Globulin Intravenous (Human), 10% Liquid Bivigam Biotest Pharmaceuticals Corporation Privigen CSL Behring AG Immune Globulin Intravenous (Human), 10% Solution Gammagard Liquid Baxter Healthcare Corp Immune Globulin Subcutaneous (Human) Hizentra CSL Behring AG Vivaglobin CSL Behring GmbH 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 Anascorp Rare Disease Therapeutics, Inc. DigiFab Protherics Inc Imugen Babesia microti Nucleic Acid Test (NAT) Babesia microti NAT/Babesia microti NAT for Blood Screening Oxford Immunotec Ltd Babesia microti AFIA/Babesia microti AFIA for Blood Donor Screening 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 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. Afluria Quadrivalent, Afluria Quadrivalent Southern Hemisphere Seqirus Pty Ltd. Agriflu Novartis Vaccines and Diagnostics, Inc. Fluarix GlaxoSmithKline Biologicals Fluarix Quadrivalent GlaxoSmithKline Biologicals Flucelvax Seqirus, Inc. Flucelvax Quadrivalent Seqirus, Inc. FluLaval ID Biomedical Corporation of Quebec FluLaval Quadrivalent ID Biomedical Corporation of Quebec Fluvirin Seqirus Vaccines Limited Fluzone, Fluzone High-Dose and Fluzone Intradermal Sanofi Pasteur, Inc Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere Sanofi Pasteur, Inc. Influenza Virus Vaccine, H5N1 (for National Stockpile) None [Influenza Virus Vaccine, H5N1] Sanofi Pasteur, Inc Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted ID Biomedical Corporation of Quebec Influenza Virus Vaccine, Live, Intranasal FluMist MedImmune Vaccines, Inc FluMist Quadrivalent MedImmune LLC Return to A - Z List J Japanese Encephalitis Vaccine, Inactivated, Adsorbed IXIARO Intercell Biomedical Return to A - Z List L lisocabtagene maraleucel BREYANZI Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Return to A - Z List 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, Inc. Bexsero Novartis Vaccines and Diagnostics, Inc. 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. Return to A - Z List N Non-Standardized Allergenic Extracts None Jubilant HollisterStier LLC Non-Standardized Allergenic Extracts None GREER Laboratories, Inc. Return to A - Z List O None OraSure HIV-1 Oral Specimen Collection Device OraSure Technologies, Inc. OLYMPUS PK System Blood Grouping and Phenotyping Reagents None [OLYMPUS PK System Blood Grouping and Phenotyping Reagents] DIAGAST onasemnogene abeparvovec-xioi ZOLGENSMA Novartis Gene Therapies, Inc. Return to A - Z List 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 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 Return to A - Z List R None RECELL Autologous Cell Harvesting Device Avita Medical Americas, LLC Rabies Immune Globulin (Human) KEDRAB Kamada Ltd. Rabies Vaccine IMOVAX Sanofi Pasteur, SA Rabies Vaccine RabAvert Novartis Vaccines and Diagnostics Reagent Red Blood Cells REFERENCELLS Immucor, Inc. Reagent Red Blood Cells ALBAcyte Alba Bioscience Limited 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 Rho(D) Immune Globulin Intravenous (Human) Rhophylac CSL Behring AG 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 Return to A - Z List S 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 Return to A - Z List 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 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 Tubersol Sanofi Pasteur, Ltd Typhoid Vaccine Live Oral Ty21a Vivotif Berna Biotech, Ltd Typhoid Vi Polysaccharide Vaccine Typhim Vi Sanofi Pasteur, SA Return to A - Z List V Vaccinia Immune Globulin Intravenous (Human) None Cangene Corp. Varicella Virus Vaccine Live Varivax Merck & Co, Inc Varicella Zoster Immune Globulin (Human) VARIZIG Cangene Corporation voretigene neparvovec-rzyl LUXTURNA Spark Therapeutics, Inc. Return to A - Z List 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 Return to A - Z List Y Yellow Fever Vaccine YF-Vax Sanofi Pasteur, Inc Return to A - Z List Z Zoster Vaccine Zostavax Merck & Co, Inc Zoster Vaccine Recombinant, Adjuvanted SHINGRIX GlaxoSmithKline Biologicals