George King SDN Control Kit

GUDID 00815696021235

George King Single Donor Normal Control Kit contains fresh frozen citrated human plasmas derived from non-medicated, non-smoking donors between the ages of 18 and 65 years of age. The kit is intended for use in establishing controlling reference ranges for coagulation assays.

GEORGE KING BIO-MEDICAL, INC

Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control

• Primary Device ID: 00815696021235
• NIH Device Record Key: 9559c75b-49c2-41a8-988e-76684336bc6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: George King SDN Control Kit
• Version Model Number: 0075-10
• Company DUNS: 066761271
• Company Name: GEORGE KING BIO-MEDICAL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• 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
• 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 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below
• Special Storage Condition, Specify: Between 0 and 0 *-70 degrees C or below

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815696021235 [Primary]

FDA Product Code

• GGN: Plasma, Coagulation Control
• GNN: Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6

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: 2020-07-06
• Device Publish Date: 2020-06-26

On-Brand Devices [George King SDN Control Kit]

• 00815696021204: George King Single Donor Normal Control Kit contains fresh frozen citrated human plasmas derived
• 00815696021235: George King Single Donor Normal Control Kit contains fresh frozen citrated human plasmas derived