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FDA 510(k)

Great Basin Toxigenic C. difficile Direct Test (CDF2)

K-Number: K232092 · 2023-11-14

ApplicantVela Operations USA
Decision Date2023-11-14
Product CodeOZN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Great Basin Toxigenic C. difficile Direct Test (CDF2) is the device name listed in this FDA 510(k) record. The listed applicant is Vela Operations USA. It received FDA 510(k) clearance on 2023-11-14 under 510(k) number K232092. 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 Great Basin Toxigenic C. difficile Direct Test (CDF2)?

Great Basin Toxigenic C. difficile Direct Test (CDF2) is a medical device that received FDA 510(k) clearance on 2023-11-14. The listed applicant is Vela Operations USA. The 510(k) number is K232092.

When did Great Basin Toxigenic C. difficile Direct Test (CDF2) receive FDA 510(k) clearance?

Great Basin Toxigenic C. difficile Direct Test (CDF2) received FDA 510(k) clearance on 2023-11-14, under 510(k) number K232092.

Who is the listed applicant for Great Basin Toxigenic C. difficile Direct Test (CDF2)?

The FDA 510(k) record lists Vela Operations USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Great Basin Toxigenic C. difficile Direct Test (CDF2)?

The FDA product code for Great Basin Toxigenic C. difficile Direct Test (CDF2) is OZN.

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.

K243730Xpert C. difficile/EpiCepheid®K212427cobas 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.

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