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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 the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2025-02-13 under 510(k) 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. The listed applicant is Hologic, Inc.. The 510(k) number is K243396.

When did Aptima SARS-CoV-2 Assay receive FDA 510(k) clearance?

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

Who is the listed applicant for Aptima SARS-CoV-2 Assay?

The FDA 510(k) record lists Hologic, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: QQX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240867cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 SystemsRoche Molecular Systems, Inc.K242109Xpert® Xpress CoV-2 plus (XPRS-COV2-10)Cepheid®K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)Abbott MolecularK233453Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR KitLife Technologies CorporationK230440Xpert® Xpress CoV-2 plusCepheid®K231306cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 SystemsRoche Molecular Systems, Inc.

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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