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FDA 510(k)

SCoV-2 Ag Detect Rapid Test

K-Number: K233358 · 2024-08-23

ApplicantInBios International, Inc.
Decision Date2024-08-23
Product CodeQVF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SCoV-2 Ag Detect Rapid 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 2024-08-23 under 510(k) number K233358. The device is classified under product code QVF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCoV-2 Ag Detect Rapid Test?

SCoV-2 Ag Detect Rapid Test is a medical device that received FDA 510(k) clearance on 2024-08-23. The listed applicant is InBios International, Inc.. The 510(k) number is K233358.

When did SCoV-2 Ag Detect Rapid Test receive FDA 510(k) clearance?

SCoV-2 Ag Detect Rapid Test received FDA 510(k) clearance on 2024-08-23, under 510(k) number K233358.

Who is the listed applicant for SCoV-2 Ag Detect Rapid 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 SCoV-2 Ag Detect Rapid Test?

The FDA product code for SCoV-2 Ag Detect Rapid Test is QVF.

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.

K251595COVID-19 Detect Rapid Self -TestK181473DENV Detect NS1 ELISAK161947Chagas Detect Plus Rapid Test

Related Devices (Code: QVF)

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.

K253882CorDx Tyfast COVID-19 Ag Rapid Test RxCorDx, Inc.K251289WELLlife COVID-19 Antigen Test RxGuangzhou Wondfo Biotech Co., Ltd.K243872BD Veritor System for SARS-CoV-2Becton, Dickinson and CompanyK250273BinaxNOW COVID-19 Ag CardAbbott Diagnostics Scarborough, Inc.K232377Healgen Rapid COVID-19 Antigen TestHealgen Scientific,, LLCK231187Nano-Check™ COVID-19 Antigen TestNano-Ditech 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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