# Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)

- Location (FDA's records): San Diego, CA
- FDA decisions: 3 (2026–2026): 3 510(k) clearances
- Names in FDA's records: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) (2); Ortho Clinical Diagnostics Inc. (QuidelOrtho) (1)
- Product codes: PSZ (1), LSR (1), QVF (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Quidel Corp.: 3 (https://510kreport.com/company/quidel)

## Recent decisions
- K254262: Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA (Sep 4, 2026)
- K254264: Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA (Sep 4, 2026)
- K254295: Sofia Lyme FIA; Sofia 2 Campylobacter FIA (Jul 10, 2026)

Source page: https://510kreport.com/company/ortho-clinical-diagnostics-quidelortho