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FDA 510(k)

Xpert Xpress Strep A

K-Number: K172126 · 2017-09-25

ApplicantCepheid
Decision Date2017-09-25
Product CodePGX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Xpert Xpress Strep A is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2017-09-25 under 510(k) number K172126. The device is classified under product code PGX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xpert Xpress Strep A?

Xpert Xpress Strep A is a medical device that received FDA 510(k) clearance on 2017-09-25. The listed applicant is Cepheid. The 510(k) number is K172126.

When did Xpert Xpress Strep A receive FDA 510(k) clearance?

Xpert Xpress Strep A received FDA 510(k) clearance on 2017-09-25, under 510(k) number K172126.

Who is the listed applicant for Xpert Xpress Strep A?

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 Strep A?

The FDA product code for Xpert Xpress Strep A is PGX.

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 FeverK261867Xpert Carba-RK253653Xpert Hemorrhagic FeverK251721Xpert GI PanelK250996Xpert Xpress CoV-2/Flu/RSV plusK250995Xpert Xpress CoV-2/Flu/RSV plus

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Related Devices (Code: PGX)

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.

K260333LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitDiasorin Molecular, LLCK201269Accula Strep A TestMesa Biotech, Inc.K183366GenePOC Strep AGenepoc, Inc.K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc.K173398Xpert Xpress Strep ACepheidK172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitLuminex Corporation

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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