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FDA 510(k)

Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA

K-Number: K254264 · 2026-09-04

ApplicantOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)
Decision Date2026-09-04
Product CodeQVF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). It received FDA 510(k) clearance on 2026-09-04 under 510(k) number K254264. The device is classified under product code QVF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA?

Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA is a medical device that received FDA 510(k) clearance on 2026-09-04. The listed applicant is Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). The 510(k) number is K254264.

When did Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA receive FDA 510(k) clearance?

Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA received FDA 510(k) clearance on 2026-09-04, under 510(k) number K254264.

Who is the listed applicant for Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA?

The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA?

The FDA product code for Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA is QVF.

Other records listing Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254262Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAK254295Sofia Lyme FIA; Sofia 2 Campylobacter FIA

Related Devices (Code: QVF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253882CorDx Tyfast COVID-19 Ag Rapid Test RxCorDx, Inc.K251289WELLlife COVID-19 Antigen Test RxGuangzhou Wondfo Biotech Co., Ltd.K243872BD Veritor System for SARS-CoV-2Becton, Dickinson and CompanyK250273BinaxNOW COVID-19 Ag CardAbbott Diagnostics Scarborough, Inc.K233358SCoV-2 Ag Detect Rapid TestInBios International, Inc.K232377Healgen Rapid COVID-19 Antigen TestHealgen Scientific,, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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