VIDAS TSH assay is intended for the determination of human TSH concentration in human serum or plasma as an aid in the diagnosis of thyroid or pituitary disorders.


Product Overview

VIDAS TSH assay is intended for the determination of human TSH concentration in human serum or plasma as an aid in the diagnosis of thyroid or pituitary disorders.
VIDAS® TSH - 30400-01


Device Description

A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen, using an enzyme immunoassay (EIA) method.


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: JLW

    Device Name: Radioimmunoassay, Thyroid-Stimulating Hormone

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    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: 862.1690

    Third Party Flag: Y

    Medical Specialty: CH


    Device Identifiers

    Device Id: 03573026156886

    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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