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FDA 510(k)

Aptima BV Assay; Aptima CV/TV Assay

K-Number: K243345 · 2024-11-25

ApplicantHologic, Inc.
Decision Date2024-11-25
Product CodePQA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Aptima BV Assay; Aptima CV/TV Assay is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2024-11-25 under approval number K243345. 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 CV/TV Assay?

Aptima BV Assay; Aptima CV/TV Assay is a medical device that received FDA 510(k) clearance on 2024-11-25. It is manufactured by Hologic, Inc.. The 510(k) number is K243345.

When was Aptima BV Assay; Aptima CV/TV Assay approved by the FDA?

Aptima BV Assay; Aptima CV/TV Assay received FDA 510(k) clearance on 2024-11-25, under approval number K243345.

What company makes Aptima BV Assay; Aptima CV/TV Assay?

Aptima BV Assay; Aptima CV/TV Assay is manufactured by Hologic, Inc..

What is the FDA product code for Aptima BV Assay; Aptima CV/TV Assay?

The FDA product code for Aptima BV Assay; Aptima CV/TV 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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