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Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
FDA product code QWB · Class 2 · Microbiology
0
Registered devices
1
Adverse events
1
Recalls
3
510(k) clearances
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-24 | CUE HEALTH INC | Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization. |
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