George King Single Donor Normal Plasma

GUDID 00815696020153

George King Single Donor Normal Plasma is fresh frozen citrated 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.

GEORGE KING BIO-MEDICAL, INC

Multiple coagulation factor IVD, control
Primary Device ID00815696020153
NIH Device Record Key5da7109d-93f1-4931-84d2-999752b98e5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeorge King Single Donor Normal Plasma
Version Model Number0001-1.0
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
GS100815696020153 [Primary]

FDA Product Code

GGNPlasma, Coagulation Control

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 Date2016-08-21

On-Brand Devices [George King Single Donor Normal Plasma]

00815696021105George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to
00815696020603George King Single Donor Normal Plasma is fresh frozen human citrated plasma and is intended to
00815696020559George King Single Donor Normal Plasma is fresh frozen citrared human plasma and is intended to
00815696020160George King Single Donor Normal Plasma is fresh frozen human citrated plasma and is intended to
00815696020153George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to
00815696021228George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to
00815696021303George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to

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