Identity
- Trade Name
- Factor XIII Calibrator EUDAMEDK-ASSAY® Factor XIII Calibrator FDA UDI
- Generic Name
- Coagulation factor XIII IVD, calibrator FDA UDI
- Device Name
- Factor XIII EUDAMEDFor the calibration of the K-ASSAY® Factor XIII assay. FDA UDI
- Model / Reference
- KAI-206C EUDAMEDFDA UDI
- Description
- For the calibration of the K-ASSAY® Factor XIII assay. FDA UDI
Identifiers
- Catalog Number
- KAI-206C FDA UDI
- Primary DI / UDI-DI
- 00816426020764 EUDAMEDFDA UDI
- Basic UDI-DI
- 081642602FXIII6K EUDAMED
- Direct Marketing DI
- 00816426020764 EUDAMED
- FDA Product Code
- DBT FDA UDI
- EMDN Code
- W0103020213 COAGULATION FACTOR XIII EUDAMED
- GMDN Term
- Coagulation factor XIII IVD, calibrator FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.5330 FDA UDI
- Market of Registration
- France 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
No
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
New Device
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Factor XIII Calibrator by Kamiya Biomedical Company, Llc — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081642602FXIII6K | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kamiya Biomedical Company, Llc
- EUDAMED SRN
- US-MF-000002769
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED edeaf828-bb0b-4654-88f6-459d297ed7c5 61 fields · synced Oct 6, 2026
- FDA UDI a26d9536-8020-4ccd-8dc8-de5dcf21151f 36 fields · synced May 30, 2026