DG Reader Net 210700

GUDID 08437014205619

DG Reader Net is a device designed to read, interpret, and report the results of the processed DG Gel 8 cards. The instrument also identifies DG Gel 8 cards by reading their barcodes. As a stand-alone or interfaced to the customer’s Laboratory Information System (LIS), the instrument automates data management requirements using DG Gel 8 cards and digital image processing.

DIAGNOSTIC GRIFOLS SA

Immunohaematology/blood bank analyser IVD, semi-automated

• Primary Device ID: 08437014205619
• NIH Device Record Key: d4820fcf-bc6b-4e9e-9933-321b7cda6d13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DG Reader Net
• Version Model Number: 210700
• Catalog Number: 210700
• 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
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437014205619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK190379

FDA Product Code

• KSZ: System, Test, Automated Blood Grouping And Antibody

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: 2019-12-05
• Device Publish Date: 2019-11-27

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