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TriniCLOT Fibrinogen Kit
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref T1301Model TriniCLOT Fibrinogen Kit
Identity
- Trade Name
- TriniCLOT Fibrinogen Kit EUDAMEDTriniCLOT™ Fibrinogen Kit FDA UDI
- Generic Name
- Fibrinogen assay (factor I) IVD, kit, clotting FDA UDI
- Device Name
- TriniCLOT Fibrinogen Kit EUDAMED
- Model / Reference
- TriniCLOT Fibrinogen Kit EUDAMEDT1301 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391521420350 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391521420350 EUDAMED
- 510(k) Number
- K971858 FDA UDI
- FDA Product Code
- KQJ FDA UDI
- EMDN Code
- W0103020201 FIBRINOGEN ASSAYS (FACTOR I) EUDAMED
- GMDN Term
- Fibrinogen assay (factor I) IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7340 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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
TriniCLOT Fibrinogen Kit by Tcoag ireland ltd — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05391521420350 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Tcoag ireland ltd
- EUDAMED SRN
- IE-MF-000027371
Sources (2)
- EUDAMED f3e1541e-71ed-40b7-b3b7-41f39f7d6691 61 fields · synced Jun 19, 2026
- FDA UDI 3fa1f190-a7bd-45b4-a091-11df463efb60 34 fields · synced May 30, 2026