Home › Device types › MZF
Test, Hiv Detection
FDA product code MZF · Class 2 · Microbiology
161
Registered devices
3,187
Adverse events
1
Recalls
0
510(k) clearances
Devices with this code
VERSANT® HIV-1 RNA 3.0 Assay bDNA — Siemens Healthcare Diagnostics Inc.Bio-Rad — Bio-RAD Laboratories, Inc.INSTI HIV-1/HIV-2 Control Test — Biolytical Laboratories IncAtellica IM CHIV QC — Siemens Healthcare Diagnostics Inc.Geenius — BIO-RADReveal G4 Rapid HIV-1/2 Antibody Test — MedMira Laboratories IncBioPlex 2200 — BIO-RAD LABORATORIES, INC.VITROS — ORTHO CLINICAL DIAGNOSTICSVERSANT® HIV-1 RNA 3.0 Assay bDNA — Siemens Healthcare Diagnostics Inc.cobas HIV-1/HIV-2 Qualitative Control Kit — Roche Molecular Systems, Inc.VITROS — ORTHO CLINICAL DIAGNOSTICSRealTime — ABBOTT MOLECULAR INC.Geenius — BIO-RADAlinity — Abbott GmbHBioPlex® 2200 — BIO-RAD LABORATORIES, INC.ADVIA Centaur® Systems EHIV QC — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHBioPlex® 2200 — BIO-RAD LABORATORIES, INC.ARCHITECT — Abbott GmbHGS — Bio-RAD Laboratories, Inc.BioPlex 2200 — BIO-RAD LABORATORIES, INC.Alinity — Abbott GmbHReveal G4 Rapid HIV-1/2 Antibody Test — MedMira Laboratories IncRealTime — ABBOTT MOLECULAR 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.
