DG Gel 8 Neutral 210393

GUDID 08437014205008

The DG Gel 8 Neutral card is for the detection of antibodies to red blood cell antigens of human blood samples and for its use as a control microtube. For use with the DG Gel System. For in vitro diagnostic use.

DIAGNOSTIC GRIFOLS SA

ABO/Rh(D)/Kell multiple blood grouping IVD, kit, agglutination

• Primary Device ID: 08437014205008
• NIH Device Record Key: 85ef1d7f-e9d5-4d40-884c-1339a24a7632
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DG Gel 8 Neutral
• Version Model Number: 210393
• Catalog Number: 210393
• 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: true
• Device Combination Product: false
• Single Use: false
• 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

Customer Support Contacts

• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437014205008 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-04-22
• Device Publish Date: 2020-11-16

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• 08437014205008 - DG Gel 8 Neutral: 2025-04-22The DG Gel 8 Neutral card is for the detection of antibodies to red blood cell antigens of human blood samples and for its use as a control microtube. For use with the DG Gel System. For in vitro diagnostic use.
• 08437014205008 - DG Gel 8 Neutral: 2025-04-22 The DG Gel 8 Neutral card is for the detection of antibodies to red blood cell antigens of human blood samples and for its use a
• 08437014205084 - DG Gel 8 Anti-K: 2025-04-16 The DG Gel 8 Anti-K card is for the determination of K antigen on the surface of red blood cells in eight human blood samples. F
• 08437014205091 - DG Gel 8 Anti-D: 2025-04-16 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
• 08437014205107 - DG Gel 8 Anti-AB: 2025-04-16 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
• 08437014205121 - DG Gel 8 Anti-E: 2025-04-16 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
• 08437014205138 - DG Gel 8 Anti-c: 2025-04-16 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