Identity
- Trade Name
- TriniCLOT™ Thrombin Time 4ml FDA UDI
- Generic Name
- Fibrinogen assay (factor I) IVD, kit, clotting FDA UDI
- Model / Reference
- T1414 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15391521420821 FDA UDI
- 510(k) Number
- K896052 FDA UDI
- FDA Product Code
- KQJ FDA UDI
- GMDN Term
- Fibrinogen assay (factor I) IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7340 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: Fibrinogen assay (factor I) IVD, kit, clotting
TriniCLOT™ Thrombin Time 4ml by Tcoag Ireland Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fibrinogen assay (factor I) IVD, kit, clotting.
- Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
- Dade Fibrinogen Determination Reagents — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Fibrinogen Assay Kit — Helena Laboratories, Corp. · Class II
- Fibrotek — R2 DIAGNOSTICS, INC. · Class II
- Diazyme — Diazyme Laboratories, Inc.
- N Antiserum to Human Fibrinogen — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Dade® Fibrinogen Determination Reagents — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- TriniCLOT™ Imidazole Buffer — TCOAG IRELAND LIMITED · Class II
Cleared under the same submission
K896052 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 d7b0ee80-39ca-4053-8ec7-5fb82c4025b1 34 fields · synced May 30, 2026