Anti-K (Human Monoclonal) Series 2

Basic Information

• Brand Name: Anti-K (Human Monoclonal) Series 2
• Primary DI: 10888234000440
• Version / Model: 0004210
• Catalog Number: 0004210
• Company Name: IMMUCOR, INC.
• Labeler DUNS: 061446282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-04
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: d76301a9-84f7-4020-81f2-f4a64513f5e8

Device Description

This reagent is used for the detection of the K antigen on red blood cells by tube test.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
52593	Anti-K (KEL001) red blood cell grouping IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for K [KEL001] red blood cell antigens from the Kell system, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888234000440	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 10 Degrees Celsius