Identity
- Trade Name
- George King SDN Control Kit FDA UDI
- Generic Name
- Multiple coagulation factor IVD, control FDA UDI
- Device Name
- George King Single Donor Normal Control Kit contains fresh frozen citrated human plasmas derived from non-medicated, non-smoking donors between the ages of 18 and 65 years of age. The kit is intended for use in establishing controlling reference ranges for coagulation assays. FDA UDI
- Model / Reference
- 0075-10 FDA UDI
- Description
- George King Single Donor Normal Control Kit contains fresh frozen citrated human plasmas derived from non-medicated, non-smoking donors between the ages of 18 and 65 years of age. The kit is intended for use in establishing controlling reference ranges for coagulation assays. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815696021235 FDA UDI
- FDA Product Code
- GGN FDA UDI
- GMDN Term
- Multiple coagulation factor 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
Yes
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
George King SDN Control Kit by George King Bio-Medical, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- George King Bio-Medical, Inc.
Sources (1)
- FDA UDI 9559c75b-49c2-41a8-988e-76684336bc6a 35 fields · synced May 30, 2026