510(k) clearance
Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA
- 510(k) number
- K254264
- 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
- QVF
- Device type
- Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
- Device class
- Class II
- Regulation
- 21 CFR 866.3982
- Advisory committee
- Microbiology
- Statement or summary
- Summary
- Third party
- N
- Location
- San Diego, CA, US