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FDA 510(k)

GenBody COVID-19 Ag Home Test

K-Number: K251916 · 2026-03-13

ApplicantGenbody.Inc.
Decision Date2026-03-13
Product CodeQYT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Genbody.Inc.. The 510(k) number is K251916.

When was GenBody COVID-19 Ag Home Test approved by the FDA?

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

What company makes GenBody COVID-19 Ag Home Test?

GenBody COVID-19 Ag Home Test is manufactured by Genbody.Inc..

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.

Related Devices (Code: QYT)

K230828Flowflex COVID-19 Antigen Home TestACON Laboratories, Inc. K241317Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)Guangzhou Wondfo Biotech Co., Ltd. K240728CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag TestCorDx, Inc. K233842iHealth COVID-19 Antigen Rapid TestIhealth Labs, Inc. K233373Flowflex® Plus COVID-19 Home TestACON Laboratories, Inc. K231795QuickVue COVID-19 TestQuidel Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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