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FDA 510(k)

Aptima BV Assay

K-Number: K190452 · 2019-05-23

ApplicantHologic, Inc.
Decision Date2019-05-23
Product CodePQA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Aptima BV Assay is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2019-05-23 under approval number K190452. The device is classified under product code PQA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aptima BV Assay?

Aptima BV Assay is a medical device that received FDA 510(k) clearance on 2019-05-23. It is manufactured by Hologic, Inc.. The 510(k) number is K190452.

When was Aptima BV Assay approved by the FDA?

Aptima BV Assay received FDA 510(k) clearance on 2019-05-23, under approval number K190452.

What company makes Aptima BV Assay?

Aptima BV Assay is manufactured by Hologic, Inc..

What is the FDA product code for Aptima BV Assay?

The FDA product code for Aptima BV Assay is PQA.

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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