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Test, Hiv Detection
FDA product code MZF · Class 2 · Microbiology
161
Registered devices
3,226
Adverse events
1
Recalls
0
510(k) clearances
Devices with this code
Alere Determine™ HIV–1/2 Ag/Ab Combo — Alere Scarborough, Inc.GS — Bio-RAD Laboratories, Inc.GS — Bio-RAD Laboratories, Inc.VERSANT® HIV-1 RNA 3.0 Assay bDNA — Siemens Healthcare Diagnostics Inc.RealTime — ABBOTT MOLECULAR INC.Uni-Gold™ — TRINITY BIOTECH PUBLIC LIMITED COMPANYBioPlex 2200 — BIO-RAD LABORATORIES, INC.GS — Bio-RAD Laboratories, Inc.cobas® HIV-1/HIV-2 Qualitative — Roche Molecular Systems, Inc.HIV-1/2 Antibody Test Controls — MedMira Laboratories IncAlinity — Abbott GmbHHIV-1 Antibody Test Controls — MedMira Laboratories IncClearview Complete HIV 1/2 — Chembio Diagnostic Systems Inc.Elecsys HIV Duo — Roche Diagnostics GmbHAlinity — Abbott GmbHHIV-1/2 Antibody Test Controls — MedMira Laboratories IncADVIA Centaur® CHIV QC — Siemens Healthcare Diagnostics Inc.GS — Bio-RAD Laboratories, Inc.GS — Bio-RAD Laboratories, Inc.Elecsys HIV combi PT — Roche Diagnostics GmbHGS — Bio-RAD Laboratories, Inc.Reveal G4 Rapid HIV-1 Antibody Test — MedMira Laboratories Inccobas® HBV/HCV/HIV-1 Control Kit — Roche Molecular Systems, Inc.GS — Bio-RAD Laboratories, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con |
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