510(k) K254264 ยท QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA
| Applicant | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho), San Diego CA, US |
| Decision | Substantially Equivalent, Sep 4, 2026 |
| Received | Dec 30, 2025 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K254264
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.