Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Total bile acid IVD, kit, spectrophotometry FDA UDI
- Device Name
- Bile Acids Kit FDA UDI
- Model / Reference
- 450-A FDA UDI
- Description
- Bile Acids Kit FDA UDI
Identifiers
- Catalog Number
- 450-A FDA UDI
- Primary DI / UDI-DI
- 05391516741927 FDA UDI
- 510(k) Number
- K872296 FDA UDI
- FDA Product Code
- KWW FDA UDI
- GMDN Term
- Total bile acid IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1177 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Total bile acid IVD, kit, spectrophotometry
Trinity Biotech by Trinity Biotech Public Limited Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total bile acid IVD, kit, spectrophotometry.
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Trinity Biotech Public Limited Company
Sources (1)
- FDA UDI 2d3e8d6f-8653-4cd5-a85a-7e77e5c75390 38 fields · synced Jun 8, 2026