DG Gel 8 Anti-K

Basic Information

• Brand Name: DG Gel 8 Anti-K
• Primary DI: 08436583731048
• Version / Model: 210225
• Catalog Number: 210225
• Company Name: DIAGNOSTIC GRIFOLS SA
• Labeler DUNS: 463625602
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-26
• Public Version: 1
• Public Version Date: 2022-06-03
• Public Version Status: New
• Public Device Record Key: 2071e482-1e41-49fb-9f29-f4a2a9644166

Device Description

The DG Gel 8 Anti-K card is for the determination of K antigen on the surface of red blood cells in eight human blood samples. For use with the DG Gel System. For in vitro diagnostic use.

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

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	08436583731048	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius