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 ID: 00815696021341
• NIH Device Record Key: 06f96ad2-923d-484d-ac14-660b0888fded
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: George King SysCOR-40 Control Kit
• Version Model Number: 0065-40
• Company DUNS: 066761271
• Company Name: GEORGE KING BIO-MEDICAL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *-70 C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 C or below

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815696021341 [Primary]

FDA Product Code

• GGC: Control, Plasma, Abnormal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-23
• Device Publish Date: 2023-03-15

Devices Manufactured by GEORGE KING BIO-MEDICAL, INC

• 00815696021341 - George King SysCOR-40 Control Kit: 2023-03-23SysCOR-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.
• 00815696021341 - George King SysCOR-40 Control Kit: 2023-03-23 SysCOR-40 Control Kit is a system control convenience kit containing 20 normal and 20 abnormal plasma controls to assist with in
• 00815696021297 - George King Pooled Normal Plasma: 2022-03-11 George King Pooled Normal Plasma is fresh frozen citrated human plasma is intended to be used as a normal control for the one-st
• 00815696021303 - George King Single Donor Normal Plasma: 2022-03-11 George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for
• 00815696021310 - George King Factor VIII Deficient Plasma: 2022-03-11 George King Factor VIII Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor VIII Deficient don
• 00815696021280 - George King Coumadin® Plasma: 2022-01-28 George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabilized on Coumadin® therapy and is
• 00815696021266 - George King von Willebrand Plasma, Type 2B: 2021-04-05 George King von Willebrand plasma, Type 2B, is a citrated human fresh frozen plasma derived from a donor diagnosed with vWD Type
• 00815696021259 - George King Pooled Normal Plasma: 2021-01-18 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 Plasma: 2020-07-06 George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for