FDA 510(k)

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System

K-Number: K212213 · 2022-02-09

Decision Date2022-02-09

Product CodePQA

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2022-02-09 under 510(k) 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. The listed applicant is Cepheid. The 510(k) number is K212213.

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

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

Who is the listed applicant for Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity 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 Dx System, GeneXpert Infinity System?

The FDA product code for Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity 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.K231381Xpert Xpress MVP; GeneXpert Xpress SystemCepheid K223653BD Vaginal PanelBecton, Dickinson and Company K221160Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.