Identity
- Trade Name
- George King Factor XI Deficient Plasma FDA UDI
- Generic Name
- Coagulation factor XI IVD, reagent FDA UDI
- Device Name
- George King Factor XI Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor XI Deficient donors. FDA UDI
- Model / Reference
- 1100-bulk FDA UDI
- Description
- George King Factor XI Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor XI Deficient donors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815696020252 FDA UDI
- FDA Product Code
- GJT FDA UDI
- GMDN Term
- Coagulation factor XI IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7290 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 XI IVD, reagent
George King Factor XI Deficient Plasma 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 XI IVD, reagent.
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- CRYOcheck™ Factor XI Deficient Plasma — Precision Biologic · Class II
- Coagulation Factor XI Deficient Plasma — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- CRYOcheck™ Factor XI Deficient Plasma — Precision Biologic · Class II
- Factor XI Deficient Substrate Plasma — Helena Laboratories, Corp. · Class II
- George King Congential Factor Deficiency Convenience Kit — GEORGE KING BIO-MEDICAL, INC. · Class II
- George King Factor XI Deficient Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
- George King Factor XI Deficient Plasma — 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 2c8b3d45-7d17-43c3-b680-d31cc3d83b71 35 fields · synced Jun 1, 2026