K242071
- 510(k) number
- K242071
- 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
- 2025-01-10
- Date received
- 2024-07-16
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K242071.pdf
Official FDA record: K242071
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.