FDA 510(k)

Xpert Xpress MVP; GeneXpert Xpress System

K-Number: K231381 · 2023-10-19

Decision Date2023-10-19

Product CodePQA

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Xpert Xpress MVP; GeneXpert Xpress System is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2023-10-19 under 510(k) 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. The listed applicant is Cepheid. The 510(k) number is K231381.

When did Xpert Xpress MVP; GeneXpert Xpress System receive FDA 510(k) clearance?

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

Who is the listed applicant for Xpert Xpress MVP; GeneXpert Xpress System?

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 MVP; GeneXpert Xpress System?

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

Other records listing Cepheid as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261362Xpert Hemorrhagic Fever K261867Xpert Carba-R K253653Xpert Hemorrhagic Fever K251721Xpert GI Panel K250996Xpert Xpress CoV-2/Flu/RSV plus K250995Xpert Xpress CoV-2/Flu/RSV plus

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Related Devices (Code: PQA)

K260021cobas® BV/CVRoche Molecular Systems, Inc.K243725BD Vaginal PanelBecton, Dickinson and Company K243345Aptima BV Assay; Aptima CV/TV AssayHologic, Inc.K223653BD Vaginal PanelBecton, Dickinson and Company K221160Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid K212213Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid

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.