IH-Card Rh-Phenotype+K

Basic Information

• Brand Name: IH-Card Rh-Phenotype+K
• Primary DI: 07611969952144
• Version / Model: 813201100
• Catalog Number: 813201100
• Company Name: Bio-Rad Medical Diagnostics GmbH
• Labeler DUNS: 312576506
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-20
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8bb788dc-3fc0-4db5-b090-dda1b8582e29

Device Description

Blood Grouping Reagent; Gel card for use with the IH-system; Card for Rh-Phenotype and Kell typing; 48 cards of 6 microtubes

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
45309	Rhesus (Rh) phenotype (CcDEe)/Kell phenotype 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] and Kell phenotype [KEL:1,2] 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	07611969952144	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Upright position
• Type: Storage Environment Temperature
• Temperature Range: 18 – 25 Degrees Celsius