Identity
- Trade Name
- Factor XIII EUDAMEDK-ASSAY® Factor XIII Reagent FDA UDI
- Generic Name
- Coagulation factor XIII IVD, reagent FDA UDI
- Device Name
- Factor XIII EUDAMEDFor the quantitative determination of human coagulation factor XIII in plasma. FDA UDI
- Model / Reference
- KAI-205 EUDAMEDFDA UDI
- Description
- For the quantitative determination of human coagulation factor XIII in plasma. FDA UDI
Identifiers
- Catalog Number
- KAI-205 FDA UDI
- Primary DI / UDI-DI
- 00816426020535 EUDAMEDFDA UDI
- Basic UDI-DI
- 081642602FXIII6K EUDAMED
- Direct Marketing DI
- 00816426020535 EUDAMED
- FDA Product Code
- DBT FDA UDI
- EMDN Code
- W0103020213 COAGULATION FACTOR XIII EUDAMED
- GMDN Term
- Coagulation factor XIII IVD, reagent 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 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 |
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Manufacturer
- Manufacturer
- Kamiya Biomedical Company, Llc
- EUDAMED SRN
- US-MF-000002769
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 8d6eb4aa-d8c7-4357-aa87-0fd0b26fe225 61 fields · synced Jul 9, 2026
- FDA UDI 88bd6317-ee6f-43ce-9872-fcb94c73d39d 36 fields · synced May 29, 2026