The product is intended for the quantitative in vitro determination of IgA in serum or plasma.


Product Overview

The product is intended for the quantitative in vitro determination of IgA in serum or plasma.
IgA - IA7157


Device Description

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antibodies to Immunoglobulin A (anti-IgA) in a clinical specimen.


Environmental Conditions

  • Special Storage Condition, Specify
    • On board the analyser the reagent is stable for 6 weeks at +10°C
  • 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: CZP

    Device Name: Iga, Antigen, Antiserum, Control

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: IM

    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: 866.5510

    Third Party Flag: Y

    Medical Specialty: IM


    Device Identifiers

    Device Id: 05055273203905

    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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