Identity
- Trade Name
- K-ASSAY® Factor XIII 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 Factor XIII. FDA UDI
- Model / Reference
- K135C-10M FDA UDI
- Description
- For use as a consistent test sample of known concentration for monitoring assay conditions for Factor XIII. FDA UDI
Identifiers
- Catalog Number
- K135C-10M FDA UDI
- Primary DI / UDI-DI
- 00816426021099 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
- 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
Category: Multiple coagulation factor IVD, control
K-ASSAY® Factor XIII Control by Kamiya Biomedical Company, Llc — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Kamiya Biomedical Company, Llc
Sources (1)
- FDA UDI 57af8a1d-2e29-44aa-b637-a14ad7a1062a 36 fields · synced Jun 8, 2026