FDA 510(k)

GenaCheck COVID-19 Rapid Self-Test

K-Number: K251753 · 2025-09-05

Decision Date2025-09-05

Product CodeQYT

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

GenaCheck COVID-19 Rapid Self-Test is a medical device manufactured by Genabio Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-09-05 under approval number K251753. 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 GenaCheck COVID-19 Rapid Self-Test?

GenaCheck COVID-19 Rapid Self-Test is a medical device that received FDA 510(k) clearance on 2025-09-05. It is manufactured by Genabio Diagnostics, Inc.. The 510(k) number is K251753.

When was GenaCheck COVID-19 Rapid Self-Test approved by the FDA?

GenaCheck COVID-19 Rapid Self-Test received FDA 510(k) clearance on 2025-09-05, under approval number K251753.

What company makes GenaCheck COVID-19 Rapid Self-Test?

GenaCheck COVID-19 Rapid Self-Test is manufactured by Genabio Diagnostics, Inc..

What is the FDA product code for GenaCheck COVID-19 Rapid Self-Test?

The FDA product code for GenaCheck COVID-19 Rapid Self-Test is QYT.

Other Devices by Genabio Diagnostics, Inc.

K240545GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)

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

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