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FDA 510(k)

Xpert Xpress CoV-2/Flu/RSV plus

K-Number: K250995 · 2025-05-01

ApplicantCepheid®
Decision Date2025-05-01
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Xpert Xpress CoV-2/Flu/RSV plus is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid®. It received FDA 510(k) clearance on 2025-05-01 under 510(k) number K250995. 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 2025-05-01. The listed applicant is Cepheid®. The 510(k) number is K250995.

When did Xpert Xpress CoV-2/Flu/RSV plus receive FDA 510(k) clearance?

Xpert Xpress CoV-2/Flu/RSV plus received FDA 510(k) clearance on 2025-05-01, under 510(k) number K250995.

Who is the listed applicant for Xpert Xpress CoV-2/Flu/RSV plus?

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

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.

Related Clinical Trials

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.

NCT05765396SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies (Level42)COMPLETED

Other records listing Cepheid® as applicant

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.

K261362Xpert Hemorrhagic FeverK261867Xpert Carba-RK253653Xpert Hemorrhagic FeverK251721Xpert GI PanelK250996Xpert Xpress CoV-2/Flu/RSV plusK243730Xpert C. difficile/Epi

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Related Devices (Code: QOF)

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.

K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices IncorporatedK252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K251742VELO Respiratory TestLex Diagnostics LimitedK251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLCK252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)Diasorin Molecular, LLCK250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQIAGEN GmbH

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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