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 plasma, Type 2B, is a 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 factor antigen in citrated plasma. FDA UDI
- Model / Reference
- 1402-50.0 FDA UDI
- Description
- George King von Willebrand plasma, Type 2B, is a 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 factor antigen in citrated plasma. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815696021266 FDA UDI
- FDA Product Code
- GGN 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
- 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 VIII-associated antigen IVD, control
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
Similar devices
Also classified as Coagulation factor VIII-associated antigen IVD, control.
- Factor VIII-Related Antigen Control Slides — BIO SB, INC. · Class I
- Factor VIII-Related Antigen Control Slides — BIO SB, INC. · Class I
- George King von Willebrand Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
- George King von Willebrand Plasma Type 1 — GEORGE KING BIO-MEDICAL, INC. · Class II
- George King von Willebrand Plasma, Type 2B — GEORGE KING BIO-MEDICAL, INC. · Class II
- George King von Willebrand Plasma, Type 3 — GEORGE KING BIO-MEDICAL, INC. · Class II
- George King von Willebrand Plasma, Type 2A — GEORGE KING BIO-MEDICAL, INC. · Class II
- George King von Willebrand Plasma Type 3 — GEORGE KING BIO-MEDICAL, INC. · Class II
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 c0dfe136-d340-4e43-83d6-feab8a67cfc7 35 fields · synced May 30, 2026