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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 a medical device manufactured by InBios International, Inc.. It received FDA 510(k) clearance on 2024-08-23 under approval 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. It is manufactured by InBios International, Inc.. The 510(k) number is K233358.

When was SCoV-2 Ag Detect Rapid Test approved by the FDA?

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

What company makes SCoV-2 Ag Detect Rapid Test?

SCoV-2 Ag Detect Rapid Test is manufactured by InBios International, Inc..

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.

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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 K251595COVID-19 Detect Rapid Self -Test

Related Devices (Code: QVF)

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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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