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510(k) Data Aggregation

    K Number
    K181017
    Device Name
    Free Testosterone AccuBind ELISA Test System
    Manufacturer
    Monobind Inc.
    Date Cleared
    2018-07-20

    (101 days)

    Product Code
    CDZ
    Regulation Number
    862.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Monobind Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Free Testosterone AccuBind® ELISA Test System is an Enzyme Immunoassay (EIA) for the quantitative measurement of free testosterone in human serum. Measurement of free testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males and in females; hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and androgenital syndromes.
    Device Description
    The kit consists of seven (7) vials of serum reference calibrators for Free Testosterone with two (2) controls (one low and one high); one (1) vial of Testosterone (Analog)-horseradish peroxidase (HRP) conjugate in a protein stabilizing matrix; one 96-well testosterone antibody-coated microplate; one (1) vial of concentrated wash solution; two (2) vials for tetramethy(benzidine (TMB) substrate solution preparation; and one (1) vial of stop reaction solution.
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