Identity
- Trade Name
- TriniCHECK™ D-Dimer 3 FDA UDI
- Generic Name
- D-dimer IVD, control FDA UDI
- Model / Reference
- T4305 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15391521420791 FDA UDI
- 510(k) Number
- K013545 FDA UDI
- FDA Product Code
- DAP FDA UDI
- GMDN Term
- D-dimer IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7320 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: D-dimer IVD, control
TriniCHECK™ D-Dimer 3 by Tcoag Ireland Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Tcoag Ireland Limited
Sources (1)
- FDA UDI bc502d92-bc90-48b5-b5f4-c025ef0ee068 34 fields · synced May 30, 2026