George King von Willebrand Plasma, Type 2A

GUDID 00815696020900

George King von Willebrand plasma, Type 2A, is citrated human fresh frozen plasma derived from a donor diagnosed with vWD Type 2A. This plasma is intended for use as a control in the quantitative determination of von Willebrand Ag in citrated plasma.

GEORGE KING BIO-MEDICAL, INC

Coagulation factor VIII-associated antigen IVD, control
Primary Device ID00815696020900
NIH Device Record Keye984c769-cde3-4a04-b0ae-61940f165154
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeorge King von Willebrand Plasma, Type 2A
Version Model Number1404 - 200.0
Company DUNS066761271
Company NameGEORGE KING BIO-MEDICAL, INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *-70˚C or below

Device Identifiers

Device Issuing AgencyDevice ID
GS100815696020900 [Primary]

FDA Product Code

GGCControl, Plasma, Abnormal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-18

On-Brand Devices [George King von Willebrand Plasma, Type 2A]

00815696020900George King von Willebrand plasma, Type 2A, is citrated human fresh frozen plasma derived from a
00815696020894George King von Willebrand plasma, Type 2A, is citrated human fresh frozen plasma derived from a
00815696020887George King von Willebrand plasma, Type 2A, is a citrated human fresh frozen plasma derived from

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