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Over-The-Counter Covid-19 Antigen Test

FDA product code QYT · 14 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3984
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-11-09 – 2026-06-05

For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.

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