DG Gel 8 Rh Pheno

Basic Information

• Brand Name: DG Gel 8 Rh Pheno
• Primary DI: 08436583731093
• Version / Model: 210228
• Catalog Number: 210228
• Company Name: DIAGNOSTIC GRIFOLS SA
• Labeler DUNS: 463625602
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-12
• Public Version: 2
• Public Version Date: 2022-10-11
• Public Version Status: Update
• Public Device Record Key: df08b040-fc6d-402b-985f-4970c5a9eb63

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
52738	Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination	A collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen to determine the Rh phenotype (CcDEe) [RH:1,2,3,4,5] of red blood cells, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08436583731093	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius