Xpert Hemorrhagic Fever
K-Number: K253653 · 2026-02-20
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 2026-02-20 under 510(k) number K253653. 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 2026-02-20. The listed applicant is Cepheid. The 510(k) number is K253653.
When did Xpert Hemorrhagic Fever receive FDA 510(k) clearance?
Xpert Hemorrhagic Fever received FDA 510(k) clearance on 2026-02-20, under 510(k) number K253653.
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.
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.
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.