LIQUID FROZEN BILIRUBIN CONTROL - LEVEL 2 (LIQ BIL CONTROL 2)

Basic Information

• Brand Name: LIQUID FROZEN BILIRUBIN CONTROL - LEVEL 2 (LIQ BIL CONTROL 2)
• Primary DI: 05055273216837
• Version / Model: BR10443
• Catalog Number: BR10443
• Company Name: RANDOX LABORATORIES LIMITED
• Labeler DUNS: 227530649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-20
• Public Version: 1
• Public Version Date: 2022-09-28
• Public Version Status: New
• Public Device Record Key: 3821cfa9-45d7-4d38-ad7b-aabc3915f4f3

Device Description

Intended for in vitro diagnostic (IVD) use as a quality control material for determination of Total Bilirubin and Direct Bilirubin on chemistry analysers. For use in a clinical laboratory setting by trained personnel.

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: Yes
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30215	Total bilirubin IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of total bilirubin in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055273216837	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -70 – -20 Degrees Celsius