Xpert Hemorrhagic Fever— 510(k) K261362

Substantially Equivalent

Cepheid

FDA 510(k) clearance K261362 for Xpert Hemorrhagic Fever, Substantially Equivalent on 2026-08-07. Applicant: Cepheid. Device class: 2.

Clearance details

Applicant
Cepheid
Product code
Code QVR
Device class
Class 2
Regulation
21 CFR 866.4000
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Dual Track
Location
Sunnyvale, CA, US
Download summary PDFView on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.