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OraQuick Advance Rapid HIV 1/2 Antibody Test
Orasure Technologies, Inc. · Model 3001-1197 · UDI-DI 00608337000016
MTL
Prescription
0
510(k) clearances
40
Adverse events
1
Recalls
3
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-12-20 | Abbott Molecular | Internal testing identified the potential of under filled and over filled enzyme reagent vials which may result in obtaining less than the total number of tests per kit as describ |
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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.