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FDA 510(k)

Aptima SARS-CoV-2 Assay

K-Number: K243396 · 2025-02-13

ApplicantHologic, Inc.
Decision Date2025-02-13
Product CodeQQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Aptima SARS-CoV-2 Assay is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2025-02-13 under approval number K243396. The device is classified under product code QQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aptima SARS-CoV-2 Assay?

Aptima SARS-CoV-2 Assay is a medical device that received FDA 510(k) clearance on 2025-02-13. It is manufactured by Hologic, Inc.. The 510(k) number is K243396.

When was Aptima SARS-CoV-2 Assay approved by the FDA?

Aptima SARS-CoV-2 Assay received FDA 510(k) clearance on 2025-02-13, under approval number K243396.

What company makes Aptima SARS-CoV-2 Assay?

Aptima SARS-CoV-2 Assay is manufactured by Hologic, Inc..

What is the FDA product code for Aptima SARS-CoV-2 Assay?

The FDA product code for Aptima SARS-CoV-2 Assay is QQX.

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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