Xpert Hemorrhagic Fever— 510(k) K261362
Substantially EquivalentCepheid
FDA 510(k) clearance K261362 for Xpert Hemorrhagic Fever, Substantially Equivalent on 2026-08-07. Applicant: Cepheid. Device class: 2.
Summary
Cepheid's Xpert Hemorrhagic Fever is filed under product code QVR, multiplex nucleic acid detection systems for biothreat agents. The record doesn't list the targets.
Class II, 21 CFR 866.4000. The Microbiology review panel handled it, though the record lists Immunology as the classification panel. The record lists the submission type as Dual Track.
Cepheid filed from Sunnyvale, California. The decision came 102 calendar days after receipt (April 27 to August 7, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Cepheid
- Product code
- Product 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
Recent devices under product code QVR
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