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FDA 510(k)

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System

K-Number: K212213 · 2022-02-09

ApplicantCepheid
Decision Date2022-02-09
Product CodePQA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System is a medical device manufactured by Cepheid. It received FDA 510(k) clearance on 2022-02-09 under approval number K212213. The device is classified under product code PQA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System?

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System is a medical device that received FDA 510(k) clearance on 2022-02-09. It is manufactured by Cepheid. The 510(k) number is K212213.

When was Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System approved by the FDA?

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System received FDA 510(k) clearance on 2022-02-09, under approval number K212213.

What company makes Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System?

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System is manufactured by Cepheid.

What is the FDA product code for Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System?

The FDA product code for Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System is PQA.

Related Clinical Trials

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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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