IH-Cell Pool

Basic Information

• Brand Name: IH-Cell Pool
• Primary DI: 07611969952281
• Version / Model: 814060100
• Catalog Number: 814060100
• 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: 72ed8a3a-05e7-47bd-8c03-e3a259bf1b0c

Device Description

Reagent Red Blood Cells; 0.6 ± 0.1 %; Pooled cells for use in detection of unexpected antibodies with IH-Cards; 1 x 10 mL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
52690	Pooled antibody screening reagent red blood cell IVD, antigen	A collection of two or three specifically characterized reagent red blood cells pooled together into a single sample, and intended to be used in screening a clinical specimen to detect antibodies to red blood cell antigens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07611969952281	GS1

Customer Contacts

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

Storage Conditions

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