Licensed Biological Products with Supporting Documents
| A | B | C | D|E|F |H | I | J | L | M | N |O | P |R | S | T |V | W |Y | Z |
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.
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. |
ALBAclone® Anti-Fyb (Human/Murine Monoclonal) | ALBAclone Anti-Fyb (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 | ||
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-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 |
Anti-Fyb ALBAsera | Alba Bioscience Limited | |
Anti-Wra 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-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 | ||
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 | ||
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 (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 | |
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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 |
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 | |
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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. |
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N | ||
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 | None [OLYMPUS PK System Blood Grouping and Phenotyping Reagents] | DIAGAST |
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 |
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 |
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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 |
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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 |
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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 |
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 |
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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. |
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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 |