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Vaccines, Blood & Biologics
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Resources for You
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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
- 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 - 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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Related Information
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Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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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