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FDA PRODUCT CODE · CLASS II

QYT — Over-The-Counter Covid-19 Antigen Test

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

DEVICE CLASS
Class II
REGULATION
21 CFR 866.3984
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES

Recent clearances

K260754Assure Tech., LLC · 510k2026-06-05
K260095Healgen Scientific,, LLC · 510k2026-04-13
K251916Genbody.Inc. · 510k2026-03-13
K251595InBios International, Inc. · 510k2025-10-12
K251753Genabio Diagnostics, Inc. · 510k2025-09-05
K241313Osang, LLC · 510k2025-05-30
K243518Abbott Diagnostics Scarborough, Inc. · 510k2025-02-11
K241915Access Bio, Inc. · 510k2025-01-29

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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