George King A-FACT

GUDID 00815696020382

George King A-FACT is a low abnormal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components.

GEORGE KING BIO-MEDICAL, INC

Multiple coagulation factor IVD, control
Primary Device ID00815696020382
NIH Device Record Keye31f7bf9-5619-4693-aefd-c18dc7241a4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeorge King A-FACT
Version Model Number0030-0.5
Company DUNS066761271
Company NameGEORGE KING BIO-MEDICAL, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS100815696020382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-08-17

On-Brand Devices [George King A-FACT]

00815696020580George King A-FACT is a low abnormal fresh frozen citrated control that is used to verify the pe
00815696020399George King A-FACT is a low abnormal fresh frozen citrated control that is used to verify the pe
00815696020382George King A-FACT is a low abnormal fresh frozen citrated control that is used to verify the pe

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