Vaccines, Blood & Biologics
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Premarket Approvals with Supporting Documents
This list includes applications for which we have approval documents available, and reflects the information as of the approval date. It is not updated with regard to applicant or application status changes. Information is arranged in alphabetical order by the name of the applicant.
Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 28 KB)
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Products
OraQuick In-Home HIV Test OraSure Technologies, Inc. GS HIV Combo Ag/Ab EIA Bio-Rad Laboratories Abbott ARCHITECT HIV Ag/Ab Combo Abbott Laboratories Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit ABBOTT Molecular, Inc Avioq HIV-1 Microelisa System Avioq, Inc. VERSANT HIV-1 RNA 3.0 Assay (bDNA) Bayer Corporation ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents Bayer HealthCare NucliSens HIV-1 QT bioMerieux, Inc Multispot HIV-1/HIV-2 Rapid Test Bio-Rad Laboratories Cambridge Biotech HIV-1 Urine Western Blot Calypte Biomedical Corp Calypte HIV-1 Urine EIA Calypte Biomedical Corp Stem Cell Concentration System CellPro, Inc Chembio SURE CHECK HIV 1/2 Assay Chembio Diagnostic Systems, Inc Chembio HIV 1/2 STAT-PAK Assay Chembio Diagnostic Systems, Inc DACS SC (Buoyant Density Solution 60) Dendreon Corp OraSure HIV-1 Western Blot Kit Epitope, Inc Home Access HIV-1 Test System Home Access Health Corp INSTI™ HIV-1 Antibody Test bioLytical Laboratories Inc. MedMira Reveal Rapid HIV-1 Antibody Test MedMira Laboratories, Inc MedMira Reveal G2 Rapid HIV-1 Antibody Test MedMira Labs Isolex 300 & 300i Magnetic Cell Selection System Nexell Therapeutics, Inc OraQuick ADVANCE Rapid HIV-1/2 Antibody Test OraSure Technologies OraQuick Rapid HIV-1/2 Antibody Test OraSure Technologies OraQuick Rapid HIV-1 Antibody Test OraSure Technologies VITROS Immunodiagnostics Products Anti-HIV 1+2 Calibrator VITROS Immunodiagnostics Products Anti-HIV 1+2 Reagent Pack Ortho-Clinical Diagnostics, Inc COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L Roche Molecular Systems, Inc Roche Amplicor HIV-1 Monitor Test Roche Molecular Systems, Inc CryoSeal FS System ThermoGenesis Corp Trinity Biotech Uni-Gold Recombigen HIV Uni-Gold Recombigen HIV Positive and Negative Controls Trinity Biotech plc
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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