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FDA 510(k)

Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA

K-Number: K254262 · 2026-09-04

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

Device Summary

Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ 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 K254262. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA?

Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ 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 K254262.

When did Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA receive FDA 510(k) clearance?

Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA received FDA 510(k) clearance on 2026-09-04, under 510(k) number K254262.

Who is the listed applicant for Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ 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 Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA?

The FDA product code for Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA is PSZ.

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.

K254264Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAK254295Sofia Lyme FIA; Sofia 2 Campylobacter FIA

Related Devices (Code: PSZ)

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.

K252283Nano-Check Influenza A+B TestNano-Ditech CorporationK250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemSEKISUI Diagnostics, LLCK232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBdK223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBdK192719Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, 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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