Identity
- Trade Name
- TriniCLOT™ PT HTF 20 mL FDA UDI
- Generic Name
- Prothrombin time (PT) IVD, kit, clotting FDA UDI
- Model / Reference
- T1101 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15391521420234 FDA UDI
- 510(k) Number
- K974566 FDA UDI
- FDA Product Code
- GJS FDA UDI
- GMDN Term
- Prothrombin time (PT) IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7750 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
Yes
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
Yes
FDA UDI
Category: Prothrombin time (PT) IVD, kit, clotting
TriniCLOT™ PT HTF 20 mL by Tcoag Ireland Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Prothrombin time (PT) IVD, kit, clotting.
- HemosIL PT-Fibrinogen — INSTRUMENTATION LABORATORY COMPANY · Class II
- STA® - Néoplastine® CI 10 — DIAGNOSTICA STAGO, INC. · Class II
- i-STAT PTplus Cartridge — Abbott Point of Care Inc. · Class II
- HemosIL RecombiPlasTin 2G (8 mL) — INSTRUMENTATION LABORATORY COMPANY · Class II
- TriniCLOT™ PT Excel 6 mL — TCOAG IRELAND LIMITED · Class II
- TriniCLOT™ PT HTF 6 mL — TCOAG IRELAND LIMITED · Class II
Cleared under the same submission
K974566 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tcoag Ireland Limited
Sources (1)
- FDA UDI a580954d-6994-4ef8-a954-86b314f715aa 34 fields · synced Jun 8, 2026