Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Total bile acid IVD, calibrator FDA UDI
- Device Name
- Bile Acid Calibrator 100 umol/l (5 mL) FDA UDI
- Model / Reference
- 450-100 FDA UDI
- Description
- Bile Acid Calibrator 100 umol/l (5 mL) FDA UDI
Identifiers
- Catalog Number
- 450-100 FDA UDI
- Primary DI / UDI-DI
- 05391516741859 FDA UDI
- 510(k) Number
- K872451 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Total bile acid IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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
No
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
Dimensions & Sizes
- Size
- Total Volume — 5 Milliliter FDA UDI
Category: Total bile acid IVD, calibrator
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, calibrator.
Cleared under the same submission
K872451 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 II | Pending data |
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Manufacturer
- Manufacturer
- Trinity Biotech Public Limited Company
Sources (1)
- FDA UDI e9a340e6-7a56-4265-9f43-49e0160cd5db 38 fields · synced May 30, 2026