George King SDN Control Kit

GUDID 00815696021204

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

• Primary Device ID: 00815696021204
• NIH Device Record Key: 90449a1d-4f58-43ea-bcec-da11693ded53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: George King SDN Control Kit
• Version Model Number: 0075-20
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815696021204 [Primary]

FDA Product Code

• GGN: Plasma, Coagulation Control

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: 2019-11-26
• Device Publish Date: 2019-11-18

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