FDA 510(k)

GenBody COVID-19 Ag Home Test

Número K: K251916 · 2026-03-13

RequerenteGenbody.Inc.

Data da decisão2026-03-13

Código do produtoQYT

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

GenBody COVID-19 Ag Home Test is the device name listed in this FDA 510(k) record. The listed applicant is Genbody.Inc.. It received FDA 510(k) clearance on 2026-03-13 under 510(k) number K251916. The device is classified under product code QYT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GenBody COVID-19 Ag Home Test?

GenBody COVID-19 Ag Home Test is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Genbody.Inc.. The 510(k) number is K251916.

When did GenBody COVID-19 Ag Home Test receive FDA 510(k) clearance?

GenBody COVID-19 Ag Home Test received FDA 510(k) clearance on 2026-03-13, under 510(k) number K251916.

Who is the listed applicant for GenBody COVID-19 Ag Home Test?

The FDA 510(k) record lists Genbody.Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GenBody COVID-19 Ag Home Test?

The FDA product code for GenBody COVID-19 Ag Home Test is QYT.

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