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George King Factor VIII Deficient Plasma with Inhibitor
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- George King Factor VIII Deficient Plasma with Inhibitor FDA UDI
- Generic Name
- Coagulation factor VIII inhibitor IVD, control FDA UDI
- Device Name
- George King Factor VIII Deficient plasma with Inhibitor is fresh frozen citrated human plasma derived from a congenital Factor VIII deficient donor who has developed an antibody to FVIII. FDA UDI
- Model / Reference
- 1800-1.5 FDA UDI
- Description
- George King Factor VIII Deficient plasma with Inhibitor is fresh frozen citrated human plasma derived from a congenital Factor VIII deficient donor who has developed an antibody to FVIII. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815696020733 FDA UDI
- FDA Product Code
- GGC FDA UDI
- GMDN Term
- Coagulation factor VIII inhibitor 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 inhibitor IVD, control
George King Factor VIII Deficient Plasma with Inhibitor by George King Bio-Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Coagulation factor VIII inhibitor IVD, control.
- CRYOcheck™ FVIII Inhibitor Kit — Precision Biologic · Class II
- George King Factor VIII Deficient Plasma with Inhibitor — GEORGE KING BIO-MEDICAL, INC. · Class II
- George King Factor VIII Deficient Plasma with Inhibitor — GEORGE KING BIO-MEDICAL, INC. · Class II
- George King Factor VIII Deficient Plasma with Inhibitor — GEORGE KING BIO-MEDICAL, INC. · Class II
- George King Factor VIII Deficient Plasma with Inhibitor — 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 c3767be5-8439-48da-9edf-7aed5299b04e 35 fields · synced Jun 8, 2026