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FDA 510(k)

Xpert GI Panel

K-Number: K251721 · 2026-01-16

ApplicantCepheid
Decision Date2026-01-16
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Xpert GI Panel is a medical device manufactured by Cepheid. It received FDA 510(k) clearance on 2026-01-16 under approval number K251721. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xpert GI Panel?

Xpert GI Panel is a medical device that received FDA 510(k) clearance on 2026-01-16. It is manufactured by Cepheid. The 510(k) number is K251721.

When was Xpert GI Panel approved by the FDA?

Xpert GI Panel received FDA 510(k) clearance on 2026-01-16, under approval number K251721.

What company makes Xpert GI Panel?

Xpert GI Panel is manufactured by Cepheid.

What is the FDA product code for Xpert GI Panel?

The FDA product code for Xpert GI Panel is PCH.

Other Devices by Cepheid

K162444Xpert MRSA NxG K161619Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems K160901Xpert Carba-R K152614Xpert Carba-R K171552Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV K172126Xpert Xpress Strep A

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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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