Bilirubin Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Total and Direct Bilirubin.


Product Overview

Bilirubin Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Total and Direct Bilirubin.
BILIRUBIN LINEARITY VERIFIER (For Roche Systems) (BILIRUBIN LIN VER ROCHE) - LV10356


Device Description

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.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • 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: 05055273216479

    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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