APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Roche Systems) (ApoLV-R)

Basic Information

• Brand Name: APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Roche Systems) (ApoLV-R)
• Primary DI: 05055273216271
• Version / Model: LV10357
• Catalog Number: LV10357
• Company Name: RANDOX LABORATORIES LIMITED
• Labeler DUNS: 227530649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-01
• Public Version: 1
• Public Version Date: 2019-08-09
• Public Version Status: New
• Public Device Record Key: 79c0a6f0-1fb0-4058-8e73-eb9c0d4baf5f

Device Description

Apo Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Apo A1 and Apo B.

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
43708	Multiple apolipoprotein IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple apolipoprotein lipid analytes in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055273216271	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -80 – -20 Degrees Celsius