DG Gel 8 Rh Pheno 210387

GUDID 08437014205046

The DG Gel 8 Rh Pheno card is for the determination of human C, E, c, and e antigens on the surface of red blood cells of two separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.

DIAGNOSTIC GRIFOLS SA

Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination

• Primary Device ID: 08437014205046
• NIH Device Record Key: 6a617207-b996-41ed-aead-0c7083d1a28e
• Commercial Distribution Discontinuation: 2016-08-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DG Gel 8 Rh Pheno
• Version Model Number: 210387
• Catalog Number: 210387
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437014205046 [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: 2021-01-28
• Device Publish Date: 2015-07-22

On-Brand Devices [DG Gel 8 Rh Pheno]

• 08437014205046: The DG Gel 8 Rh Pheno card is for the determination of human C, E, c, and e antigens on the surf
• 08436583731093: The DG Gel 8 Rh Pheno card is for the determination of human C, E, c, and e antigens on the surf