George King Positive Lupus Anticoagulant

Basic Information

• Brand Name: George King Positive Lupus Anticoagulant
• Primary DI: 00815696021112
• Version / Model: 5000 - 100 mL
• Company Name: GEORGE KING BIO-MEDICAL, INC
• Labeler DUNS: 066761271
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-22
• Public Version: 1
• Public Version Date: 2018-07-23
• Public Version Status: New
• Public Device Record Key: 67bf3035-0a62-4adb-8050-bdd5760378fd

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GGC	Control, Plasma, Abnormal	Hematology	864.5425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46029	Lupus anticoagulant marker IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple Lupus anticoagulant markers in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815696021112	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K945856	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Specify -70˚C or below