K250996
- 510(k) number
- K250996
- Device name
- Xpert Xpress CoV-2/Flu/RSV plus
- Applicant
- Cepheid® CA · US
- Product code
- QOF — Multi-Target Respiratory Specimen Nucleic Acid Test
- Decision date
- 2025-05-01
- Date received
- 2025-04-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Microbiology
510(k) Summary (official FDA PDF): K250996.pdf
Official FDA record: K250996
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.