IH-Panel Plus 6

Basic Information

• Brand Name: IH-Panel Plus 6
• Primary DI: 07611969952311
• Version / Model: 814090100
• Catalog Number: 814090100
• 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: 201d49b5-1b8c-4942-851e-aff5d3f7b64f

Device Description

Reagent Red Blood Cells; 0.6 ± 0.1 %; For Use in identification of unexpected antibodies with IH-Cards; 6 x 4 mL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
52543	Antibody identification panel reagent red blood cell IVD, kit, agglutination	A collection of four or more specifically characterized reagent red blood cells that are supplied together as a set and intended to be used to determine the exact specificity of antibodies to red blood cell antigens present in a clinical specimen, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07611969952311	GS1

Customer Contacts

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

Storage Conditions

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