For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.


Product Overview

For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.
Total Thyroxine (T4) ELISA - EIA-1781


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple thyroid markers associated with thyroid disease in a clinical specimen using an enzyme immunoassay (EIA) method. Analytes detected may include, but are not limited to, free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH) and/or thyroid peroxidase (TPO).


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

  • Conjugate Diluent
  • Total Volume: 11 Milliliter
  • TMB
  • Stop Solution
  • Standards
  • Total Volume: 13 Milliliter
  • Conjugate Concentrate
  • Total Volume: 1.3 Milliliter
  • Total Volume: 1 Milliliter
    • Conjugate Diluent
    • Total Volume: 11 Milliliter
    • TMB
    • Stop Solution
    • Standards
    • Total Volume: 13 Milliliter
    • Conjugate Concentrate
    • Total Volume: 1.3 Milliliter
    • Total Volume: 1 Milliliter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: KLI

    Device Name: Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

    Device Class: 2

    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: 862.1700

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00840239017819

    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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