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George King Single Donor Normal Plasma

FDA UDI

Class II (US FDA UDI)

by George King Bio-Medical, Inc.

Identity

Trade Name
George King Single Donor Normal Plasma FDA UDI
Generic Name
Multiple coagulation factor IVD, control FDA UDI
Device Name
George King Single Donor Normal Plasma is fresh frozen citrared human plasma and is intended to be used as a normal control for the one-stage prothrombin time (PT) assay, the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. FDA UDI
Model / Reference
0001-1.5 FDA UDI
Description
George King Single Donor Normal Plasma is fresh frozen citrared human plasma and is intended to be used as a normal control for the one-stage prothrombin time (PT) assay, the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. FDA UDI

Identifiers

Primary DI / UDI-DI
00815696020559 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 Single Donor 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

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Manufacturer

Manufacturer
George King Bio-Medical, Inc.

Sources (1)

  • FDA UDI ba7b5c3b-ed13-4db9-97f3-b5872402013c 35 fields · synced Jun 6, 2026