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


Product Overview

Apo Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Apo A1 and Apo B.
APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Roche Systems) (ApoLV-R) - LV10357


Device Description

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.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • -20.00
    • -80.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: JJY

    Device Name: Multi-Analyte Controls, All Kinds (Assayed)

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: CH

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 862.1660

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 05055273216271

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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