DG Gel 8 Direct Coombs

GUDID 08437014205909

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.

DIAGNOSTIC GRIFOLS SA

Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody

• Primary Device ID: 08437014205909
• NIH Device Record Key: e333cede-a891-4281-a447-1f719e47506e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DG Gel 8 Direct Coombs
• Version Model Number: 210129
• Company DUNS: 463625602
• Company Name: DIAGNOSTIC GRIFOLS SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437014205909 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-18
• Device Publish Date: 2022-07-08

Devices Manufactured by DIAGNOSTIC GRIFOLS SA

• 08436583731215 - Blood Typing Manager: 2023-08-30 Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology
• 08437014205244 - Grifols Diluent: 2023-06-02 Grifols Diluent is for use in preparing human red blood cell suspensions used with the DG Gel 8 cards.
• 08436583730980 - Blood Typing Manager: 2022-12-01 Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology
• 08436583731024 - DG Gel 8 Anti-D: 2022-10-18 The DG Gel 8 Anti-D card is for the determination of D antigen on the surface of red blood cells of eight human blood samples. F
• 08436583731031 - DG Gel 8 Anti-AB: 2022-10-18 The DG Gel 8 Anti-AB card is for the determination of human A and B antigens on the surface of red blood cells of eight human bl
• 08436583731055 - DG Gel 8 Anti-C: 2022-10-18 For the determination of human C antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel
• 08436583731062 - DG Gel 8 Anti-E: 2022-10-18 For the determination of human E antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel
• 08436583731079 - DG Gel 8 Anti-c: 2022-10-18 For the determination of human c antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel