Identity
- Trade Name
- K-ASSAY® Fibrinogen Reagent FDA UDI
- Generic Name
- Fibrinogen assay (factor I) IVD, reagent FDA UDI
- Device Name
- For the quantitative determination of human fibrinogen in plasma. FDA UDI
- Model / Reference
- KAI-135 FDA UDI
- Description
- For the quantitative determination of human fibrinogen in plasma. FDA UDI
Identifiers
- Catalog Number
- KAI-135 FDA UDI
- Primary DI / UDI-DI
- 00816426021075 FDA UDI
- 510(k) Number
- K993482 FDA UDI
- FDA Product Code
- GIS FDA UDI
- GMDN Term
- Fibrinogen assay (factor I) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7340 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, reagent
K-ASSAY® Fibrinogen Reagent 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, reagent.
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Cleared under the same submission
K993482 also covers:
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 308f5fad-8ff6-4692-a28f-661daf666a67 37 fields · synced May 29, 2026