Source document or public record
FDA 510(k) K254262 — Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA
FDA 510(k) index record K254262. Device: Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA. Applicant as listed: Ortho Clinical Diagnostics Inc. (QuidelOrtho). Decision date: 2026-09-04.
Source
"device_name": "Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K254262.
Device name: Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA. Applicant as listed: Ortho Clinical Diagnostics Inc. (QuidelOrtho).
Decision date: 2026-09-04. Decision wording: Substantially Equivalent.
Product code: PSZ. Regulation: 21 CFR 866.3328. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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