George King Positive Lupus Anticoagulant

GUDID 00815696020436

George King Positive Lupus Anticoagulant is fresh frozen citrated human plasma derived from donors who have been diagnosed with Anti-Phospholipid Antibody Syndrome (APS)

GEORGE KING BIO-MEDICAL, INC

Lupus anticoagulant marker IVD, control

• Primary Device ID: 00815696020436
• NIH Device Record Key: 9acd6bbd-a5a7-4038-a3bd-5ec956520c05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: George King Positive Lupus Anticoagulant
• Version Model Number: 5000-0.5
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815696020436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945856

FDA Product Code

• GGC: Control, Plasma, Abnormal

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: 2016-08-20

On-Brand Devices [George King Positive Lupus Anticoagulant]

• 00815696021112: George King Positive Lupus Anticoagulant is citrated human fresh frozen plasma derived from dono
• 00815696020849: George King Positive Lupus Anticoagulant is citrated human fresh frozen plasma derived from dono
• 00815696020450: George King Positive Lupus Anticoagulant is citrated human fresh frozen plasma derived from dono
• 00815696020443: George King Positive Lupus Anticoagulant is fresh frozen citrated human plasma derived from dono
• 00815696020436: George King Positive Lupus Anticoagulant is fresh frozen citrated human plasma derived from dono
• 00815696021143: George King Positive Lupus Anticoagulant is citrated fresh frozen human plasma derived from dono