Identity
- Trade Name
- George King von Willebrand plasma, Type 2B FDA UDI
- Generic Name
- Coagulation factor VIII-associated antigen IVD, control FDA UDI
- Device Name
- George King von Willebrand, Type 2B, is citrated human fresh frozen plasma derived from a donor diagnosed with vWD Type 2B. This plasma is intended for use as a control in the quantitative determination of von Willebrand aG in citrated plasma. FDA UDI
- Model / Reference
- 1402 - 1.5 FDA UDI
- Description
- George King von Willebrand, Type 2B, is citrated human fresh frozen plasma derived from a donor diagnosed with vWD Type 2B. This plasma is intended for use as a control in the quantitative determination of von Willebrand aG in citrated plasma. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815696020979 FDA UDI
- FDA Product Code
- GGC FDA UDI
- GMDN Term
- Coagulation factor VIII-associated antigen IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Commercial Distribution
- Not 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
George King von Willebrand plasma, Type 2B 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 5e28ad12-fe34-43be-aa25-97ba354b6d13 35 fields · synced May 30, 2026