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FDA 510(k)

Aptima Trichomonas vaginalis Assay

K-Number: K231316 · 2023-11-06

ApplicantHologic, Inc.
Decision Date2023-11-06
Product CodeOUY
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Aptima Trichomonas vaginalis Assay is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2023-11-06 under approval number K231316. The device is classified under product code OUY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aptima Trichomonas vaginalis Assay?

Aptima Trichomonas vaginalis Assay is a medical device that received FDA 510(k) clearance on 2023-11-06. It is manufactured by Hologic, Inc.. The 510(k) number is K231316.

When was Aptima Trichomonas vaginalis Assay approved by the FDA?

Aptima Trichomonas vaginalis Assay received FDA 510(k) clearance on 2023-11-06, under approval number K231316.

What company makes Aptima Trichomonas vaginalis Assay?

Aptima Trichomonas vaginalis Assay is manufactured by Hologic, Inc..

What is the FDA product code for Aptima Trichomonas vaginalis Assay?

The FDA product code for Aptima Trichomonas vaginalis Assay is OUY.

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

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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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