Premarket Approvals and Humanitarian Device Exemptions 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.
Products
- Alinity m HIV-1
- Abbott ARCHITECT HIV Ag/Ab Combo
- Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit
- ADVIA Centaur HIV Ag/Ab Combo (CHIV) Assay
- ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents
- Aptima HIV-1 Quant Dx Assay
- Avioq HIV-1 Microelisa System
- BioPlex 2200 HIV Ag-Ab Assay
- Calypte HIV-1 Urine EIA
- Cambridge Biotech HIV-1 Urine Western Blot
- CliniMACS CD34 Reagent System
- Chembio DPP HIV 1/2 Assay
- Chembio HIV 1/2 STAT-PAK Assay
- Chembio SURE CHECK HIV 1/2 Assay
- COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L
- cobas HIV-1
- cobas HIV-1/HIV-2 Qualitative
- CryoSeal FS System
- Determine HIV-1/2 Ag/Ab Combo
- DPP HIV-Syphilis System
- DACS SC (Buoyant Density Solution 60)
- Elecsys HIV Duo
- Elecsys HIV combi PT
- Epicel (cultured epidermal autografts)
- Geenius HIV 1/2 Supplemental Assay
- GS HIV Combo Ag/Ab EIA
- Home Access HIV-1 Test System
- ID CORE XT (Reagents and Analysis Software)
- Immucor PreciseType Human Erythrocyte Antigen (HEA) Molecular BeadChip Test
- INSTI HIV-1/HIV-2 Antibody Test
- INTERCEPT Blood System for Plasma
- INTERCEPT Blood System for Platelets
- Isolex 300 & 300i Magnetic Cell Selection System
- LIAISON XL MUREX HIV Ab/Ag HT and Control HIV Ab/Ag HT
- MedMira Reveal G2 Rapid HIV-1 Antibody Test
- MedMira Reveal Rapid HIV-1 Antibody Test
- Multispot HIV-1/HIV-2 Rapid Test
- NucliSens HIV-1 QT
- OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
- Oraquick In-Home HIV Test
- OraQuick Rapid HIV-1 Antibody Test
- OraQuick Rapid HIV-1/2 Antibody Test
- OraSure HIV-1 Oral Specimen Collection Device
- OraSure HIV-1 Western Blot Kit
- RECELL Autologous Cell Harvesting Device
- RECELL Autologous Cell Harvesting Device (Model Number: AVRL0102)
- Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4)
- Roche Amplicor HIV-1 Monitor Test
- Uni-Gold Recombigen HIV-1/2
- QUELIMMUNE
- Stem Cell Concentration System
- VERSANT HIV-1 RNA 3.0 Assay (bDNA)
- VioOne HIV Profile Supplemental Assay
- VITROS Immunodiagnostics Products Anti-HIV 1+2 Calibrator VITROS Immunodiagnostics Products Anti-HIV 1+2 Reagent Pack
- VITROS Immunodiagnostic Products HIV Combo Reagent Pack & VITROS Immunodiagnostic Products HIV Combo Calibrator
Related Information
- Complete List of Currently Approved Premarket Approvals (PMAs)
- Premarket Approval (PMA) for CBER-Regulated Products
- Biologics Products & Establishments