West Nile Virus IgG Positive Control DxSelect™ - IgG Positive Control


Product Overview

West Nile Virus IgG Positive Control DxSelect™ - IgG Positive Control - EL0311


Device Description

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to West Nile virus 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: NOP

    Device Name: Elisa, Antibody, West Nile Virus

    Device Class: 2

    Physical State: N/A

    Definition: The West Nile Virus ELISA is intended for the detection of IgG and IgM antibodies to West Nile Virus. Specimens may be serum or cerebral spinal fluid from symptomatic patients.

    Submission Type ID: 1

    Review Panel: MI

    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: 866.3940

    Third Party Flag: N

    Medical Specialty: MI


    Device Identifiers

    Device Id: 10816101022332

    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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