Identity
- Trade Name
- FibroTek Fibrinogen kit EUDAMEDFibrotek FDA UDI
- Generic Name
- Fibrinogen assay (factor I) IVD, kit, clotting FDA UDI
- Device Name
- FibroTek Fibrinogen kit EUDAMEDFibrinogen assay 100 DET FDA UDI
- Model / Reference
- 70-410 EUDAMEDFDA UDI
- Description
- Fibrinogen assay 100 DET FDA UDI
Identifiers
- Catalog Number
- 70-410 FDA UDI
- Primary DI / UDI-DI
- 00859394006040 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00859394006040 EUDAMED
- 510(k) Number
- K042919 FDA UDI
- FDA Product Code
- KQJ FDA UDIGIS FDA UDI
- EMDN Code
- W0103020701 CALIBRATION PLASMA FOR HAEMOSTASIS 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
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
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
No
FDA UDI
Category: Fibrinogen assay (factor I) IVD, kit, clotting
Fibrotek by R2 Diagnostics, Inc. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fibrinogen assay (factor I) IVD, kit, clotting.
- TriniCLOT™ Thrombin Time 4ml — TCOAG IRELAND LIMITED · Class II
- Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
- TriniCLOT™ Imidazole Buffer — TCOAG IRELAND LIMITED · Class II
- Dade Fibrinogen Determination Reagents — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Fibrinogen Assay Kit — Helena Laboratories, Corp. · Class II
- TriniCLOT™ Thrombin Time 1ml — TCOAG IRELAND LIMITED · Class II
- TriniCLOT™ Fibrinogen 6 mL — TCOAG IRELAND LIMITED · Class II
- TriniCAL™ Fibrinogen — TCOAG IRELAND LIMITED · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| 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
- R2 Diagnostics, Inc.
Sources (2)
- FDA UDI 66e55df2-d77d-4c53-934d-4f614535f860 35 fields · synced Jul 30, 2026
- EUDAMED 8013861c-76e5-4025-87c9-babcb78288f5 61 fields · synced Jul 30, 2026