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FDA 510(k)

Xpert Xpress CoV-2/Flu/RSV plus

K-Number: K242071 · 2025-01-10

ApplicantCepheid
Decision Date2025-01-10
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Xpert Xpress CoV-2/Flu/RSV plus is a medical device manufactured by Cepheid. It received FDA 510(k) clearance on 2025-01-10 under approval number K242071. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xpert Xpress CoV-2/Flu/RSV plus?

Xpert Xpress CoV-2/Flu/RSV plus is a medical device that received FDA 510(k) clearance on 2025-01-10. It is manufactured by Cepheid. The 510(k) number is K242071.

When was Xpert Xpress CoV-2/Flu/RSV plus approved by the FDA?

Xpert Xpress CoV-2/Flu/RSV plus received FDA 510(k) clearance on 2025-01-10, under approval number K242071.

What company makes Xpert Xpress CoV-2/Flu/RSV plus?

Xpert Xpress CoV-2/Flu/RSV plus is manufactured by Cepheid.

What is the FDA product code for Xpert Xpress CoV-2/Flu/RSV plus?

The FDA product code for Xpert Xpress CoV-2/Flu/RSV plus is QOF.

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Related Devices (Code: QOF)

DEN200031BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC K231481Xpert Xpress CoV-2/Flu/RSV plusCepheid® K230956BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ SystemBd Integrated Diagnostic Solutions / K223591cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® SystemRoche Molecular Systems, Inc. K222736Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. K230719BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBiofire Diagnostics, LLC

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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