FDA 510(k)

Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

K-Number: K242109 · 2025-01-15

Decision Date2025-01-15

Product CodeQQX

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Xpert® Xpress CoV-2 plus (XPRS-COV2-10) is a medical device manufactured by Cepheid®. It received FDA 510(k) clearance on 2025-01-15 under approval number K242109. 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 Xpert® Xpress CoV-2 plus (XPRS-COV2-10)?

Xpert® Xpress CoV-2 plus (XPRS-COV2-10) is a medical device that received FDA 510(k) clearance on 2025-01-15. It is manufactured by Cepheid®. The 510(k) number is K242109.

When was Xpert® Xpress CoV-2 plus (XPRS-COV2-10) approved by the FDA?

Xpert® Xpress CoV-2 plus (XPRS-COV2-10) received FDA 510(k) clearance on 2025-01-15, under approval number K242109.

What company makes Xpert® Xpress CoV-2 plus (XPRS-COV2-10)?

Xpert® Xpress CoV-2 plus (XPRS-COV2-10) is manufactured by Cepheid®.

What is the FDA product code for Xpert® Xpress CoV-2 plus (XPRS-COV2-10)?

The FDA product code for Xpert® Xpress CoV-2 plus (XPRS-COV2-10) is QQX.

Other Devices by Cepheid®

K230440Xpert® Xpress CoV-2 plus K231481Xpert Xpress CoV-2/Flu/RSV plus K223046Xpert® FII & FV K243625Xpert MRSA/SA SSTI K243405Xpert vanA K243070Xpert® SA Nasal Complete

View all 10 devices →

Related Devices (Code: QQX)

K211079BioFire COVID-19 Test 2Biofire Defense, LLC K213804cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsRoche Molecular Systems, Inc. K212147Simplexa COVID-19 DirectDiasorin Molecular, LLC K221460BioFire COVID-19 Test 2Biofire Defense, LLC K230440Xpert® 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.