K261362
- 510(k) number
- K261362
- Device name
- Xpert Hemorrhagic Fever
- Applicant
- Cepheid CA · US
- Product code
- QVR — Multiplex Nucleic Acid Detection System For Biothrea
- Decision date
- 2026-08-07
- Date received
- 2026-04-27
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K261362.pdf
Official FDA record: K261362
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.