Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Clostridium difficile antigen IVD, kit, agglutination FDA UDI
- Device Name
- Uni-Gold™ C. difficile GDH, 20 Tests FDA UDI
- Model / Reference
- 1206640 FDA UDI
- Description
- Uni-Gold™ C. difficile GDH, 20 Tests FDA UDI
Identifiers
- Catalog Number
- 1206640 FDA UDI
- Primary DI / UDI-DI
- 05391516748797 FDA UDI
- FDA Product Code
- MCB FDA UDI
- GMDN Term
- Clostridium difficile antigen IVD, kit, agglutination 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
No
FDA UDI
Prescription Use
No
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
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 antigen IVD, kit, agglutination
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 e5e65a17-fc15-4581-93f5-ba05541860bb 36 fields · synced May 29, 2026