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artus® CMV QS-RGQ MDx Kit
QIAGEN GmbH · Model 1 · UDI-DI 04053228024538
PAB
Prescription
0
510(k) clearances
18
Adverse events
1
Recalls
10
Facilities
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. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.