Clearance Summary
Xpert Hemorrhagic Fever received FDA 510(k) clearance under submission number K261362, sponsored by Cepheid. The device was reviewed via the Dual Track premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2026-08-07.
- Submission: K261362
- Applicant / Sponsor: Cepheid
- Clearance pathway: Dual Track
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.4000
- Decision date: 2026-08-07
Classification & Regulation
This clearance is catalogued under FDA product code QVR and 21 CFR 866.4000, within the Immunology review panel as a Class II device.