DG Gel 8 ABO/Rh 210118

GUDID 08437014205077

The DG Gel 8 ABO/Rh card is for the determination of ABO forward and reverse group and D antigen on the surface of red blood cells, and for ABO Compatibility Test in human blood samples. For use with Manual Method. Not for use with Erytra or WADiana Compact. For in vitro diagnostic use.

DIAGNOSTIC GRIFOLS SA

ABO/Rh multiple blood grouping IVD, kit, agglutination

• Primary Device ID: 08437014205077
• NIH Device Record Key: b2173fec-693d-4b4b-b17b-25fbc2683554
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DG Gel 8 ABO/Rh
• Version Model Number: 210118
• Catalog Number: 210118
• 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: 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

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
• 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
• 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	08437014205077 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-10-19
• Device Publish Date: 2015-10-29

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• 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
• 08437014205145 - 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
• 08437014205183 - WADiana Compact: 2025-04-16 WADiana Compact is a fully automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing