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Toxigenic C. difficile Direct Test 01

by Vela Operations USA

Toxigenic C. difficile Direct Test 01 (300786) is a clostridium difficile nucleic acid IVD (FDA Class II; FDA product code OZN, C. Difficile Toxin Gene Amplification Assay) made by Vela Operations USA, listed in FDA GUDID since 18 Jan 2024 (UDI-DI G491CDF20), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberG491CDF20 UDI-DI Date18 Jan 2024ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Toxigenic C. difficile Direct Test
Generic name
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
01, 300786
Primary DI / UDI-DI
G491CDF20
FDA product code
OZN
GMDN term
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Device class
Class II
Regulation number
866.3130
GUDID distribution status
In Commercial Distribution

Related devices

Category: Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Other devices from Vela Operations USA

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)