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FDA 510(k)

Aptima HCV Quant Dx Assay

K-Number: K233352 · 2024-07-24

ApplicantHologic, Inc.
Decision Date2024-07-24
Product CodeMZP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Aptima HCV Quant Dx Assay is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2024-07-24 under approval number K233352. The device is classified under product code MZP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aptima HCV Quant Dx Assay?

Aptima HCV Quant Dx Assay is a medical device that received FDA 510(k) clearance on 2024-07-24. It is manufactured by Hologic, Inc.. The 510(k) number is K233352.

When was Aptima HCV Quant Dx Assay approved by the FDA?

Aptima HCV Quant Dx Assay received FDA 510(k) clearance on 2024-07-24, under approval number K233352.

What company makes Aptima HCV Quant Dx Assay?

Aptima HCV Quant Dx Assay is manufactured by Hologic, Inc..

What is the FDA product code for Aptima HCV Quant Dx Assay?

The FDA product code for Aptima HCV Quant Dx Assay is MZP.

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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