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FDA 510(k)

Xpert Respiratory Panel

K-Number: K261336 · 2026-09-25

ApplicantCepheid
Decision Date2026-09-25
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Xpert Respiratory Panel is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K261336. 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 Respiratory Panel?

Xpert Respiratory Panel is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Cepheid. The 510(k) number is K261336.

When did Xpert Respiratory Panel receive FDA 510(k) clearance?

Xpert Respiratory Panel received FDA 510(k) clearance on 2026-09-25, under 510(k) number K261336.

Who is the listed applicant for Xpert Respiratory Panel?

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 Respiratory Panel?

The FDA product code for Xpert Respiratory Panel is QOF.

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 plusK250995Xpert Xpress CoV-2/Flu/RSV plus

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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.

K263054BIOFIRE Respiratory Panel 2.1 (RP2.1)Biofire DiagnosticsK261837FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.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, 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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