FDA 510(k)

GenBody COVID-19 Ag Home Test

Номер K: K251916 · 2026-03-13

ЗаявительGenbody.Inc.

Дата решения2026-03-13

Код продуктаQYT

Консультативный комитетMI

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: QYT)

K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestAssure Tech., LLC K260095Heal-Check Rapid COVID-19 Antigen Self-TestHealgen Scientific,, LLC K251595COVID-19 Detect Rapid Self -TestInBios International, Inc.K251753GenaCheck COVID-19 Rapid Self-TestGenabio Diagnostics, Inc.K241313OHC COVID-19 Antigen Self TestOsang, LLC K243518BinaxNOW™ COVID-19 Antigen Self TestAbbott Diagnostics Scarborough, Inc.

Официальный источник

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