DG Gel 8 Anti-C 210121

GUDID 08437014205114

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 System. For in vitro diagnostic use.

DIAGNOSTIC GRIFOLS SA

Anti-C [RH002] red blood cell grouping IVD, antibody

• Primary Device ID: 08437014205114
• NIH Device Record Key: aff9a4f3-6317-47a8-988f-55d0439a61c2
• Commercial Distribution Discontinuation: 2025-04-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DG Gel 8 Anti-C
• Version Model Number: 210121
• Catalog Number: 210121
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437014205114 [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: 2025-04-14
• Device Publish Date: 2015-10-29

On-Brand Devices [DG Gel 8 Anti-C]

• 08436583731079: For the determination of human c antigen on the surface of red blood cells of eight human blood
• 08436583731055: For the determination of human C antigen on the surface of red blood cells of eight human blood
• 08437014205114: For the determination of human C antigen on the surface of red blood cells of eight human blood
• 08437014205138: For the determination of human c antigen on the surface of red blood cells of eight human blood