# FDA 510(k) cleared: Sofia Lyme FIA; Sofia 2 Campylobacter FIA

> fda · VERIFIED · 2026-07-10

Applicant: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) · Substantially Equivalent

- Company: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
- Sector: Sofia Lyme FIA; Sofia 2 Campylobacter FIA
- Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254295

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Source: MedFuel Intel news monitor. Verification tier: VERIFIED. Informational only, not investment advice. Corrections: media@medfuelinc.com.