For the direct quantitative determination of Free Testosterone by enzyme immunoassay in human serum. For in vitro diagnostic use only.


Product Overview

For the direct quantitative determination of Free Testosterone by enzyme immunoassay in human serum. For in vitro diagnostic use only.
Free Testosterone ELISA - EIA-4638


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free testosterone 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: CDZ

    Device Name: Radioimmunoassay, Testosterones And Dihydrotestosterone

    Device Class: 1

    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: 862.1680

    Third Party Flag: Y

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00840239046383

    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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