Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA— 510(k) K254264

Name: FDA 510(k) clearance K254264
Creator: U.S. Food and Drug Administration
Published: 2026-09-04

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)

FDA 510(k) clearance K254264 for Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA, Substantially Equivalent on 2026-09-04. Applicant: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). Device class: 2.

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
Product code: Code QVF
Device class: Class 2
Regulation: 21 CFR 866.3982
Advisory panel: Microbiology
Date received: 2025-12-30
Decision date: 2026-09-04
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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