Identity
- Trade Name
- K-ASSAY® Coagulation Control FDA UDI
- Generic Name
- Multiple coagulation factor IVD, control FDA UDI
- Device Name
- For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents. FDA UDI
- Model / Reference
- K104C-10M FDA UDI
- Description
- For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents. FDA UDI
Identifiers
- Catalog Number
- K104C-10M FDA UDI
- Primary DI / UDI-DI
- 00816426020924 FDA UDI
- FDA Product Code
- DBT FDA UDI
- GMDN Term
- Multiple coagulation factor IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.5330 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
K-ASSAY® Coagulation Control by Kamiya Biomedical Company, Llc — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Kamiya Biomedical Company, Llc
Sources (2)
- FDA UDI 110e79ff-6590-4b04-8bf3-d370c570e9fc 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026