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FDA 510(k)

Aptima CMV Quant Assay

K-Number: K243935 · 2025-01-17

ApplicantHologic, Inc.
Decision Date2025-01-17
Product CodePAB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Aptima CMV Quant Assay is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2025-01-17 under approval number K243935. The device is classified under product code PAB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aptima CMV Quant Assay?

Aptima CMV Quant Assay is a medical device that received FDA 510(k) clearance on 2025-01-17. It is manufactured by Hologic, Inc.. The 510(k) number is K243935.

When was Aptima CMV Quant Assay approved by the FDA?

Aptima CMV Quant Assay received FDA 510(k) clearance on 2025-01-17, under approval number K243935.

What company makes Aptima CMV Quant Assay?

Aptima CMV Quant Assay is manufactured by Hologic, Inc..

What is the FDA product code for Aptima CMV Quant Assay?

The FDA product code for Aptima CMV Quant Assay is PAB.

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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