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FDA 510(k)

COVID-19 Detect Rapid Self -Test

K-Number: K251595 · 2025-10-12

ApplicantInBios International, Inc.
Decision Date2025-10-12
Product CodeQYT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COVID-19 Detect Rapid Self -Test is a medical device manufactured by InBios International, Inc.. It received FDA 510(k) clearance on 2025-10-12 under approval number K251595. 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 COVID-19 Detect Rapid Self -Test?

COVID-19 Detect Rapid Self -Test is a medical device that received FDA 510(k) clearance on 2025-10-12. It is manufactured by InBios International, Inc.. The 510(k) number is K251595.

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

COVID-19 Detect Rapid Self -Test received FDA 510(k) clearance on 2025-10-12, under approval number K251595.

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

COVID-19 Detect Rapid Self -Test is manufactured by InBios International, Inc..

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

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

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Other Devices by InBios International, Inc.

K161947Chagas Detect Plus Rapid Test K181473DENV Detect NS1 ELISA DEN180069ZIKV Detect 2.0 IgM Capture ELISA DEN220044Active Anthrax DetectTM Plus Rapid Test K233358SCoV-2 Ag Detect Rapid Test

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.

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