George King Positive Lupus Anticoagulant

GUDID 00815696020436

George King Positive Lupus Anticoagulant is fresh frozen citrated human plasma derived from donors who have been diagnosed with Anti-Phospholipid Antibody Syndrome (APS)

GEORGE KING BIO-MEDICAL, INC

Lupus anticoagulant marker IVD, control
Primary Device ID00815696020436
NIH Device Record Key9acd6bbd-a5a7-4038-a3bd-5ec956520c05
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeorge King Positive Lupus Anticoagulant
Version Model Number5000-0.5
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
GS100815696020436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-08-20

On-Brand Devices [George King Positive Lupus Anticoagulant]

00815696021112George King Positive Lupus Anticoagulant is citrated human fresh frozen plasma derived from dono
00815696020849George King Positive Lupus Anticoagulant is citrated human fresh frozen plasma derived from dono
00815696020450George King Positive Lupus Anticoagulant is citrated human fresh frozen plasma derived from dono
00815696020443George King Positive Lupus Anticoagulant is fresh frozen citrated human plasma derived from dono
00815696020436George King Positive Lupus Anticoagulant is fresh frozen citrated human plasma derived from dono
00815696021143George King Positive Lupus Anticoagulant is citrated fresh frozen human plasma derived from dono

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