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FDA 510(k)

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

K-Number: K203429 · 2022-05-09

ApplicantCepheid
Decision Date2022-05-09
Product CodeNJR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System is a medical device manufactured by Cepheid. It received FDA 510(k) clearance on 2022-05-09 under approval 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. It is manufactured by Cepheid. The 510(k) number is K203429.

When was Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System approved by the FDA?

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

What company makes Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System?

Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System is manufactured by Cepheid.

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.

Related Clinical Trials

NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT04594993 INFINITY™ With ADAPTIS™ Technology Study ACTIVE_NOT_RECRUITING

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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.

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