Home › Device types › PAB
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA product code PAB · Class 2 · Microbiology
21
Registered devices
18
Adverse events
1
Recalls
3
510(k) clearances
Devices with this code
Aptima® — Hologic, Inc.cobas CMV Control Kit — Roche Molecular Systems, Inc.RealTime — ABBOTT MOLECULAR INC.Alinity m — ABBOTT MOLECULAR INC.cobas CMV — Roche Molecular Systems, Inc.RealTime — ABBOTT MOLECULAR INC.cobas® CMV Control Kit — Roche Molecular Systems, Inc.Aptima® — Hologic, Inc.Alinity m — ABBOTT MOLECULAR INC.Aptima® — Hologic, Inc.artus® CMV RGQ MDx Kit — QIAGEN GmbHAptima® — Hologic, Inc.COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test — Roche Molecular Systems, Inc.artus® CMV QS-RGQ MDx Kit — QIAGEN GmbHAlinity m — ABBOTT MOLECULAR INC.cobas® CMV — Roche Molecular Systems, Inc.Alinity m — ABBOTT MOLECULAR INC.RealTime — ABBOTT MOLECULAR INC.RealTime — ABBOTT MOLECULAR INC.RealTime — ABBOTT MOLECULAR INC.Alinity m — ABBOTT MOLECULAR INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-14 | Hologic, Inc. | Use of assay along with plasma specimen may result in error code which would invalidate sample. |
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.