Source document or public record
FDA 510(k) K232092 — Great Basin Toxigenic C. difficile Direct Test (CDF2)
FDA 510(k) index record K232092. Device: Great Basin Toxigenic C. difficile Direct Test (CDF2). Applicant as listed: Vela Operations USA. Decision date: 2023-11-14.
Source
"device_name": "Great Basin Toxigenic C. difficile Direct Test (CDF2)"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K232092.
Device name: Great Basin Toxigenic C. difficile Direct Test (CDF2). Applicant as listed: Vela Operations USA.
Decision date: 2023-11-14. Decision wording: Substantially Equivalent.
Product code: OZN. Regulation: 21 CFR 866.3130. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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