George King AbCOR Convenience Kit

Basic Information

• Brand Name: George King AbCOR Convenience Kit
• Primary DI: 00815696021068
• Version / Model: 0085-20
• Company Name: GEORGE KING BIO-MEDICAL, INC
• Labeler DUNS: 066761271
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-17
• Public Version: 4
• Public Version Date: 2023-04-03
• Public Version Status: Update
• Public Device Record Key: c42d7ff6-face-4033-a94a-cc3febe0e3a9
• Distribution End Date: 2023-04-01

Device Description

George King Abnormal Correlation (AbCOR) Kit is a convenience kit containing 20 vials of select control material that can be used to correlate reagent lot numbers and/or instrument platforms. (individual product inserts are included with each kit)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
30590	Multiple coagulation factor IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815696021068	GS1

Customer Contacts

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