FDA 510(k)

Xpert Hemorrhagic Fever

K-Number: K261362 · 2026-08-07

Decision Date2026-08-07

Product CodeQVR

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

Xpert Hemorrhagic Fever is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2026-08-07 under 510(k) number K261362. The device is classified under product code QVR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xpert Hemorrhagic Fever?

Xpert Hemorrhagic Fever is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Cepheid. The 510(k) number is K261362.

When did Xpert Hemorrhagic Fever receive FDA 510(k) clearance?

Xpert Hemorrhagic Fever received FDA 510(k) clearance on 2026-08-07, under 510(k) number K261362.

Who is the listed applicant for Xpert Hemorrhagic Fever?

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 Hemorrhagic Fever?

The FDA product code for Xpert Hemorrhagic Fever is QVR.

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.

K261867Xpert Carba-R K253653Xpert Hemorrhagic Fever K251721Xpert GI Panel K250996Xpert Xpress CoV-2/Flu/RSV plus K250995Xpert Xpress CoV-2/Flu/RSV plus K243730Xpert C. difficile/Epi

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Related Devices (Code: QVR)

K231336T2 Biothreat PanelT2biosystems, Inc.K213362BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens PanelBiofire Defense, 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.