George King A-FACT

GUDID 00815696020580

George King A-FACT is a low abnormal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components.

GEORGE KING BIO-MEDICAL, INC

Multiple coagulation factor IVD, control

• Primary Device ID: 00815696020580
• NIH Device Record Key: 2b4da223-240b-4fe1-af25-e7008e89dd15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: George King A-FACT
• Version Model Number: 0030-1.5
• 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: false
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815696020580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945855

FDA Product Code

• GGN: Plasma, Coagulation Control

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-17

On-Brand Devices [George King A-FACT]

• 00815696020580: George King A-FACT is a low abnormal fresh frozen citrated control that is used to verify the pe
• 00815696020399: George King A-FACT is a low abnormal fresh frozen citrated control that is used to verify the pe
• 00815696020382: George King A-FACT is a low abnormal fresh frozen citrated control that is used to verify the pe