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FDA 510(k)

Xpert Xpress MVP; GeneXpert Xpress System

K-Number: K231381 · 2023-10-19

ApplicantCepheid
Decision Date2023-10-19
Product CodePQA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Xpert Xpress MVP; GeneXpert Xpress System is a medical device manufactured by Cepheid. It received FDA 510(k) clearance on 2023-10-19 under approval number K231381. 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 Xpress System?

Xpert Xpress MVP; GeneXpert Xpress System is a medical device that received FDA 510(k) clearance on 2023-10-19. It is manufactured by Cepheid. The 510(k) number is K231381.

When was Xpert Xpress MVP; GeneXpert Xpress System approved by the FDA?

Xpert Xpress MVP; GeneXpert Xpress System received FDA 510(k) clearance on 2023-10-19, under approval number K231381.

What company makes Xpert Xpress MVP; GeneXpert Xpress System?

Xpert Xpress MVP; GeneXpert Xpress System is manufactured by Cepheid.

What is the FDA product code for Xpert Xpress MVP; GeneXpert Xpress System?

The FDA product code for Xpert Xpress MVP; GeneXpert Xpress System is PQA.

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Related Devices (Code: PQA)

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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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