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FDA 510(k)

BD DIRECTIGEN EZ FLU A+B ASSAY

K-Number: K101529 · 2010-06-14

ApplicantBecton, Dickinson & CO
Decision Date2010-06-14
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD DIRECTIGEN EZ FLU A+B ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson & CO. It received FDA 510(k) clearance on 2010-06-14 under 510(k) number K101529. 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 BD DIRECTIGEN EZ FLU A+B ASSAY?

BD DIRECTIGEN EZ FLU A+B ASSAY is a medical device that received FDA 510(k) clearance on 2010-06-14. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K101529.

When did BD DIRECTIGEN EZ FLU A+B ASSAY receive FDA 510(k) clearance?

BD DIRECTIGEN EZ FLU A+B ASSAY received FDA 510(k) clearance on 2010-06-14, under 510(k) number K101529.

Who is the listed applicant for BD DIRECTIGEN EZ FLU A+B ASSAY?

The FDA 510(k) record lists Becton, Dickinson & CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD DIRECTIGEN EZ FLU A+B ASSAY?

The FDA product code for BD DIRECTIGEN EZ FLU A+B ASSAY is PSZ.

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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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