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FDA 510(k)

SOFIA ANALYZER AND INFLUENZA A+B FIA

K-Number: K112177 · 2011-10-24

ApplicantQuidel Corp.
Decision Date2011-10-24
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SOFIA ANALYZER AND INFLUENZA A+B FIA is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 2011-10-24 under 510(k) number K112177. 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 ANALYZER AND INFLUENZA A+B FIA?

SOFIA ANALYZER AND INFLUENZA A+B FIA is a medical device that received FDA 510(k) clearance on 2011-10-24. The listed applicant is Quidel Corp.. The 510(k) number is K112177.

When did SOFIA ANALYZER AND INFLUENZA A+B FIA receive FDA 510(k) clearance?

SOFIA ANALYZER AND INFLUENZA A+B FIA received FDA 510(k) clearance on 2011-10-24, under 510(k) number K112177.

Who is the listed applicant for SOFIA ANALYZER AND INFLUENZA A+B FIA?

The FDA 510(k) record lists Quidel Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFIA ANALYZER AND INFLUENZA A+B FIA?

The FDA product code for SOFIA ANALYZER AND INFLUENZA A+B FIA is PSZ.

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Other records listing Quidel Corp. 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.

K131813QUIDEL MOLECULAR RSV + HMPV ASSAYK131728QUIDEL MOLECULAR INFLUENZA A + B ASSAYK130398SOFIA(R) RSV FIAK131166SOFIA(R) HCG FIAK131606SOFIA INFLUENZA A+B FIAK131619QUICKVUE INFLUENZA A+B

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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.

K254262Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho)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 KitBd

Official Source

View on FDA Database →

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

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