Documento fuente o registro público
FDA 510(k) K254295 — Sofia Lyme FIA; Sofia 2 Campylobacter FIA
FDA 510(k) index record K254295. Device: Sofia Lyme FIA; Sofia 2 Campylobacter FIA. Applicant as listed: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). Decision date: 2026-07-10.
Fuente
"device_name": "Sofia Lyme FIA; Sofia 2 Campylobacter FIA"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-22
professional use
FDA 510(k) public index record K254295.
Device name: Sofia Lyme FIA; Sofia 2 Campylobacter FIA. Applicant as listed: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho).
Decision date: 2026-07-10. Decision wording: Substantially Equivalent.
Product code: LSR. Regulation: 21 CFR 866.3830. 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.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.