The TSH receptor (TSHR) autoantibody (TRAb) ELISA kit is intended for use by professional persons only for the quantitative determination of TRAb in human serum


Product Overview

The TSH receptor (TSHR) autoantibody (TRAb) ELISA kit is intended for use by professional persons only for the quantitative determination of TRAb in human serum
TSH Receptor Autoantibody ELISA - EIA-3369


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to thyroid stimulating hormone receptor (TSHR), also known as thyrotropin receptor, in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used in the diagnosis of autoimmune thyroid disorders such as hyperthyroidism in Graves’ disease.


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: JZO

    Device Name: System, Test, Thyroid Autoantibody

    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: 866.5870

    Third Party Flag: Y

    Medical Specialty: IM


    Device Identifiers

    Device Id: 00840239033697

    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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