Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Bartels® Cytotoxicity Assay for Clostridium difficile Toxin Product B1029-70, Store Toxi-Titer Plate @ 35-37 °C, Store Reagents @ 2-8 °C, 48 Tests FDA UDI
- Model / Reference
- B1029-70 FDA UDI
- Description
- Bartels® Cytotoxicity Assay for Clostridium difficile Toxin Product B1029-70, Store Toxi-Titer Plate @ 35-37 °C, Store Reagents @ 2-8 °C, 48 Tests FDA UDI
Identifiers
- Catalog Number
- B1029-70 FDA UDI
- Primary DI / UDI-DI
- 05391516747950 FDA UDI
- 510(k) Number
- K833447 FDA UDI
- FDA Product Code
- MCB FDA UDI
- GMDN Term
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA) 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
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 antigen IVD, kit, enzyme immunoassay (EIA)
Trinity Biotech by Mardx Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K833447 also covers:
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 9a22cd1f-9421-4036-9152-aacaa800ec0a 37 fields · synced Jun 6, 2026