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George King Factor XIII Deficient Plasma

FDA UDI

Class II (US FDA UDI)

by George King Bio-Medical, Inc.

Identity

Trade Name
George King Factor XIII Deficient Plasma FDA UDI
Generic Name
Coagulation factor XIII A subunit IVD, control FDA UDI
Device Name
George King Factor XIII Deficient plasma is fresh frozen citrated human plasma derived from a congenital Factor XIII deficient donor. FDA UDI
Model / Reference
1300-0.5 FDA UDI
Description
George King Factor XIII Deficient plasma is fresh frozen citrated human plasma derived from a congenital Factor XIII deficient donor. FDA UDI

Identifiers

Primary DI / UDI-DI
00815696020320 FDA UDI
FDA Product Code
GGC FDA UDI
GMDN Term
Coagulation factor XIII A subunit 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 XIII A subunit IVD, control

George King Factor XIII 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 XIII A subunit IVD, control.

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 081bc2d8-be6a-49c5-a8e0-64c2f234887e 35 fields · synced Jun 8, 2026