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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

DateFirmReason
2024-05-24CUE HEALTH INCDue to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.