FDA 510(k)

Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems

K-Number: K222638 · 2023-09-27

Decision Date2023-09-27

Product CodeNJR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems is a medical device manufactured by Cepheid. It received FDA 510(k) clearance on 2023-09-27 under approval number K222638. 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® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems?

Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems is a medical device that received FDA 510(k) clearance on 2023-09-27. It is manufactured by Cepheid. The 510(k) number is K222638.

When was Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems approved by the FDA?

Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems received FDA 510(k) clearance on 2023-09-27, under approval number K222638.

What company makes Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems?

Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems is manufactured by Cepheid.

What is the FDA product code for Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems?

The FDA product code for Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems is NJR.

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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.