Identity
- Trade Name
- George King Pooled Normal Plasma FDA UDI
- Generic Name
- Multiple coagulation factor IVD, control FDA UDI
- Device Name
- George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged PT or aPTT. FDA UDI
- Model / Reference
- 0010-10.0 FDA UDI
- Description
- George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged PT or aPTT. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815696021259 FDA UDI
- FDA Product Code
- GGN FDA UDI
- GMDN Term
- Multiple coagulation factor 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 Pooled Normal 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 b061c402-c32a-47d7-8fee-9ad846301a32 36 fields · synced May 30, 2026