George King SysCOR-40 Control Kit

GUDID 00815696021341

SysCOR-40 Control Kit is a system control convenience kit containing 20 normal and 20 abnormal plasma controls to assist with instrument correlations and reagent crossover studies.

GEORGE KING BIO-MEDICAL, INC

Multiple coagulation factor IVD, control
Primary Device ID00815696021341
NIH Device Record Key06f96ad2-923d-484d-ac14-660b0888fded
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeorge King SysCOR-40 Control Kit
Version Model Number0065-40
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 Kittrue
Device Combination Productfalse
Single Usefalse
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
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
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
Special Storage Condition, SpecifyBetween 0 and 0 *-70 C or below
Special Storage Condition, SpecifyBetween 0 and 0 *-70 C or below
Special Storage Condition, SpecifyBetween 0 and 0 *-70 C or below
Special Storage Condition, SpecifyBetween 0 and 0 *-70 C or below
Special Storage Condition, SpecifyBetween 0 and 0 *-70 C or below
Special Storage Condition, SpecifyBetween 0 and 0 *-70 C or below
Special Storage Condition, SpecifyBetween 0 and 0 *-70 C or below
Special Storage Condition, SpecifyBetween 0 and 0 *-70 C or below
Special Storage Condition, SpecifyBetween 0 and 0 *-70 C or below
Special Storage Condition, SpecifyBetween 0 and 0 *-70 C or below
Special Storage Condition, SpecifyBetween 0 and 0 *-70 C or below
Special Storage Condition, SpecifyBetween 0 and 0 *-70 C or below
Special Storage Condition, SpecifyBetween 0 and 0 *-70 C or below
Special Storage Condition, SpecifyBetween 0 and 0 *-70 C or below
Special Storage Condition, SpecifyBetween 0 and 0 *-70 C or below
Special Storage Condition, SpecifyBetween 0 and 0 *-70 C or below

Device Identifiers

Device Issuing AgencyDevice ID
GS100815696021341 [Primary]

FDA Product Code

GGCControl, Plasma, Abnormal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-23
Device Publish Date2023-03-15

Devices Manufactured by GEORGE KING BIO-MEDICAL, INC

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00815696021259 - George King Pooled Normal Plasma2021-01-18 George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the on
00815696021228 - George King Single Donor Normal Plasma2020-07-06 George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for

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