Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Xpert C. difficile/Epi

K-Number: K243730 · 2025-02-28

ApplicantCepheid®
Decision Date2025-02-28
Product CodeOZN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Xpert C. difficile/Epi is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid®. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K243730. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xpert C. difficile/Epi?

Xpert C. difficile/Epi is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Cepheid®. The 510(k) number is K243730.

When did Xpert C. difficile/Epi receive FDA 510(k) clearance?

Xpert C. difficile/Epi received FDA 510(k) clearance on 2025-02-28, under 510(k) number K243730.

Who is the listed applicant for Xpert C. difficile/Epi?

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 C. difficile/Epi?

The FDA product code for Xpert C. difficile/Epi is OZN.

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

View all 37 devices →

Related Devices (Code: OZN)

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.

K232092Great Basin Toxigenic C. difficile Direct Test (CDF2)Vela Operations USAK212427cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.K210385cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.K172569GenePOC CDiffGenepoc, Inc.K171770cobas Cdiff Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.K171441ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension 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.

↑