Identity
- Trade Name
- Toxigenic C. difficile Direct Test FDA UDI
- Generic Name
- Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- 01 FDA UDI
Identifiers
- Catalog Number
- 300786 FDA UDI
- Primary DI / UDI-DI
- G491CDF20 FDA UDI
- FDA Product Code
- OZN FDA UDI
- GMDN Term
- Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Toxigenic C. difficile Direct Test by Vela Operations USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT).
- BD MAX™ Cdiff (US) — BECTON DICKINSON AND COMPANY · Class II
- Alethia™ C. difficile — MERIDIAN BIOSCIENCE, INC. · Class I
- Portrait Toxigenic C. difficile Assay — Great Basin Scientific, Inc. · Class II
- Revogene C. difficile — MERIDIAN BIOSCIENCE, INC. · Class II
- Simplexa™ C.difficile Sample Prep Kit — DiaSorin Molecular LLC · Class II
- Xpert C. difficile — CEPHEID · Class I
- Lyra — Quidel Corp. · Class II
- Xpert C. difficile/Epi — CEPHEID · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vela Operations USA
Sources (1)
- FDA UDI ed2f2e9b-54d2-405d-9494-8e09186b7606 34 fields · synced Jun 6, 2026