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 the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2023-09-27 under 510(k) 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. The listed applicant is Cepheid. The 510(k) number is K222638.

When did Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems receive FDA 510(k) clearance?

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

Who is the listed applicant for Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems?

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

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

Other records listing Cepheid as applicant

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Related Devices (Code: NJR)

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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.