FDA 510(k)

Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System

K-Number: K203429 · 2022-05-09

Decision Date2022-05-09

Product CodeNJR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2022-05-09 under 510(k) number K203429. The device is classified under product code NJR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System?

Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System is a medical device that received FDA 510(k) clearance on 2022-05-09. The listed applicant is Cepheid. The 510(k) number is K203429.

When did Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System receive FDA 510(k) clearance?

Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System received FDA 510(k) clearance on 2022-05-09, under 510(k) number K203429.

Who is the listed applicant for Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System?

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

What is the FDA product code for Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System?

The FDA product code for Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System is NJR.

Other records listing Cepheid as applicant

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Related Devices (Code: NJR)

K222638Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity SystemsCepheid K182467Simplexa GBS Direct, Simplexa GBS Positive Control PackDiasorin Molecular, LLC K181156Panther Fusion GBS AssayDiagenode K173725NeuMoDx GBS AssayNeumodx Molecular, Inc.K173250Solana GBS AssayQuidel Corporation K170557GenePOC GBS LBGenepoc, Inc.

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.