Identity
- Trade Name
- George King Prekallikrein Deficient Plasma FDA UDI
- Generic Name
- Coagulation factor prekallikrein/kallikrein IVD, control FDA UDI
- Device Name
- George King Prekallikrein Deficient plasma is fresh frozen citrated human plasma derived from congenital Prekallikrein Deficient donors FDA UDI
- Model / Reference
- 1700-1.0 FDA UDI
- Description
- George King Prekallikrein Deficient plasma is fresh frozen citrated human plasma derived from congenital Prekallikrein Deficient donors FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815696020092 FDA UDI
- FDA Product Code
- GGC FDA UDI
- GMDN Term
- Coagulation factor prekallikrein/kallikrein 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
No
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: Coagulation factor prekallikrein/kallikrein IVD, control
George King Prekallikrein Deficient Plasma by George King Bio-Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 5735d0e4-841d-4768-a26d-4519e048d405 35 fields · synced May 30, 2026