DG Gel 8 Direct Coombs

Basic Information

• Brand Name: DG Gel 8 Direct Coombs
• Primary DI: 08437014205909
• Version / Model: 210129
• Company Name: DIAGNOSTIC GRIFOLS SA
• Labeler DUNS: 463625602
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-08
• Public Version: 1
• Public Version Date: 2022-07-18
• Public Version Status: New
• Public Device Record Key: e333cede-a891-4281-a447-1f719e47506e

Device Description

The DG Gel 8 Direct Coombs card is used for the evaluation of the Direct Antiglobulin Test of two different human blood samples. It allows to differentiate red blood cells sensitized in vivo by IgG type immunoglobulins or the complement C3d fractions. 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: 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

GMDN Terms

Code	Name	Definition	Implantable	Status
46948	Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody	One or multiple immunoglobulins capable of binding to human antibodies from immunoglobulin class G (IgG) that are fixed to red blood cell antigens. This immunoglobulin, known as monospecific immunoglobulin G antihuman globulin (IgG AHG) is intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by human IgG, using an agglutination or solid-phase red blood cell adherence method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08437014205909	GS1