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FDA 510(k)

BD DIRECTIGEN EZ RSV KIT

K-Number: K022133 · 2002-12-10

ApplicantBecton, Dickinson & CO
Decision Date2002-12-10
Product CodeGQG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD DIRECTIGEN EZ RSV KIT 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 2002-12-10 under 510(k) number K022133. The device is classified under product code GQG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD DIRECTIGEN EZ RSV KIT?

BD DIRECTIGEN EZ RSV KIT is a medical device that received FDA 510(k) clearance on 2002-12-10. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K022133.

When did BD DIRECTIGEN EZ RSV KIT receive FDA 510(k) clearance?

BD DIRECTIGEN EZ RSV KIT received FDA 510(k) clearance on 2002-12-10, under 510(k) number K022133.

Who is the listed applicant for BD DIRECTIGEN EZ RSV KIT?

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 RSV KIT?

The FDA product code for BD DIRECTIGEN EZ RSV KIT is GQG.

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Other records listing Becton, Dickinson & CO as applicant

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K160164BD Veritor System for Rapid Detection of Flu A + B Labratory KitK160161BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitK133140BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSVK133138BD Veritor™ System Flu A+B AssayK130268BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAYK131301BD FACS SAMPLE PREP ASSISTANT III

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Related Devices (Code: GQG)

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.

K253318Clungene RSV Antigen Rapid TestHangzhou Clongene Biotech Co., Ltd.K240280Nano-Check™ RSV TestNano-Ditech CorporationK162911Sofia RSV FIA on Sofia 2 analyzerQuidel CorporationK133140BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSVBecton, Dickinson & COK132456BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSVBecton, Dickinson and CompanyK130398SOFIA(R) RSV FIAQuidel Corp.

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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