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: 2
• Public Version Date: 2025-04-30
• Public Version Status: Update
• 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.

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
46949	Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination	A collection of immunoglobulins capable of binding to individual classes of human immunoglobulin and/or complement components fixed to red blood cell antigens, and intended to be used together in testing a clinical specimen to detect red blood cell sensitization by specific molecules, using an agglutination technique. The specific molecules intended to be detected may include immunoglobulin A (IgA), immunoglobulin G (IgG), immunoglobulin M (IgM), C3c, and/or C3d.	No	Active

Identifiers

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