Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Clostridium difficile toxin A/B antigen IVD, kit, agglutination, rapid FDA UDI
- Device Name
- Uni-Gold™ C. difficile Toxin A/B, 20 Tests FDA UDI
- Model / Reference
- 1206630 FDA UDI
- Description
- Uni-Gold™ C. difficile Toxin A/B, 20 Tests FDA UDI
Identifiers
- Catalog Number
- 1206630 FDA UDI
- Primary DI / UDI-DI
- 05391516748773 FDA UDI
- FDA Product Code
- LLH FDA UDI
- GMDN Term
- Clostridium difficile toxin A/B antigen IVD, kit, agglutination, rapid FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 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
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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 toxin A/B antigen IVD, kit, agglutination, rapid
Trinity Biotech by Mardx Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Mardx Diagnostics, Inc.
Sources (1)
- FDA UDI 95bee479-ef05-4a9e-ace8-baa636256007 36 fields · synced Jun 8, 2026