510(k) clearance
Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA
- 510(k) number
- K254262
- Applicant
- Ortho Clinical Diagnostics Inc. (QuidelOrtho)
- Decision date
- Sep 4, 2026
- Date received
- Dec 30, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Product code
- PSZ
- Device type
- Devices Detecting Influenza A, B, And C Virus Antigens
- Device class
- Class II
- Regulation
- 21 CFR 866.3328
- Advisory committee
- Microbiology
- Statement or summary
- Summary
- Third party
- N
- Location
- San Diego, CA, US