DG Gel 8 ABO/Rh+Kell

Basic Information

• Brand Name: DG Gel 8 ABO/Rh+Kell
• Primary DI: 08437014205923
• Version / Model: 210383
• Catalog Number: 210383
• Company Name: DIAGNOSTIC GRIFOLS SA
• Labeler DUNS: 463625602
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-15
• Public Version: 3
• Public Version Date: 2022-01-31
• Public Version Status: Update
• Public Device Record Key: 8b8ca24c-c7ea-49e0-bab3-27e20540bbd6
• Distribution End Date: 2022-01-31

Device Description

The DG Gel 8 ABO/Rh + Kell card is for the determination of ABO forward and reverse group, and D and K antigens on the surface of red blood cells of 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
47009	ABO/Rh(D)/Kell multiple blood grouping IVD, kit, agglutination	A collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen for a combination of one or multiple ABO system, Rh(D) [RH001] and Kell [KEL001] red blood cell antigens, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08437014205923	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius