Identity
- Trade Name
- K-ASSAY® Fibrinogen Control FDA UDI
- Generic Name
- Fibrinogen assay (factor I) IVD, control FDA UDI
- Device Name
- For use as a consistent test sample of known concentration for monitoring assay conditions for fibrinogen. FDA UDI
- Model / Reference
- K63C-10M FDA UDI
- Description
- For use as a consistent test sample of known concentration for monitoring assay conditions for fibrinogen. FDA UDI
Identifiers
- Catalog Number
- K63C-10M FDA UDI
- Primary DI / UDI-DI
- 00816426020870 FDA UDI
- FDA Product Code
- GGN FDA UDI
- GMDN Term
- Fibrinogen assay (factor I) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 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
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, control
K-ASSAY® Fibrinogen Control by Kamiya Biomedical Company, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Fibrinogen assay (factor I) IVD, control.
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- Dade® Data-Fi® Abnormal Fibrinogen Control — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Fibrinogen control slides — BIO SB, INC. · Class I
- CRYOcheck™ Low Fibrinogen Control — Precision Biologic · Class II
- Fibrinogen Control Slides — BIO SB, INC. · Class I
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 II | Pending data |
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Manufacturer
- Manufacturer
- Kamiya Biomedical Company, Llc
Sources (1)
- FDA UDI 91d92f4c-4d57-4493-89a3-2bd0ab5dd81f 36 fields · synced May 30, 2026