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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 the device name listed in this FDA 510(k) record. The listed applicant is InBios International, Inc.. It received FDA 510(k) clearance on 2025-10-12 under 510(k) 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. The listed applicant is InBios International, Inc.. The 510(k) number is K251595.

When did COVID-19 Detect Rapid Self -Test receive FDA 510(k) clearance?

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

Who is the listed applicant for COVID-19 Detect Rapid Self -Test?

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

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.

Related Clinical Trials

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NCT05333679Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)COMPLETED

Other records listing InBios International, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233358SCoV-2 Ag Detect Rapid TestK181473DENV Detect NS1 ELISAK161947Chagas Detect Plus Rapid Test

Related Devices (Code: QYT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestAssure Tech., LLCK260095Heal-Check Rapid COVID-19 Antigen Self-TestHealgen Scientific,, LLCK251916GenBody COVID-19 Ag Home TestGenbody.Inc.K251753GenaCheck COVID-19 Rapid Self-TestGenabio Diagnostics, Inc.K241313OHC COVID-19 Antigen Self TestOsang, LLCK243518BinaxNOW™ COVID-19 Antigen Self TestAbbott Diagnostics Scarborough, Inc.

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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