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510(k) Data Aggregation

    K Number
    K062534
    Device Name
    ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE
    Manufacturer
    DRG INTL., INC.
    Date Cleared
    2008-01-29

    (518 days)

    Product Code
    JLX
    Regulation Number
    862.1395
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRG INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K052649
    Device Name
    DRG SLV TESTOSTERONE ELISA TEST
    Manufacturer
    DRG INTL., INC.
    Date Cleared
    2006-01-27

    (123 days)

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

    DRG INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An Enzyme Immunoassay for the in vitro diagnostic quantitative measurement of free active testosterone in saliva. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delaved or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
    Device Description
    The DRG Salivary Testosterone ELISA Kit is based on the competition princible and the microplate separation. An unknown amount of free testosterone present in the sample and a fixed amount of testosterone conjugated with horseradish peroxidase compete for the binding sites of mouse monoclonal testosterone -antiserum coated onto the wells. After one hour incubation the microplate is washed to stop the competition reaction. After addition of the substrate solution the concentration of testosterone is inversely proportional to the optical density measured.
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    K Number
    K051733
    Device Name
    ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL
    Manufacturer
    DRG INTL., INC.
    Date Cleared
    2005-12-07

    (162 days)

    Product Code
    NHG
    Regulation Number
    862.1205
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRG INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free cortisol (hydrocortisone and hydroxycorticosterone) in saliva. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
    Device Description
    The DRG Salivary Cortisol ELISA KIT is based on the competition principle and the microplate separation. An unknown amount of Cortisol present in the sample and a fixed amount of Cortisol coniugated with horseradish peroxidase compete for the binding sites of mouse polyclonal Cortisol-antiserum coated onto the wells. After one hour incubation the microplate is washed to stop the competition reaction. After addition of the TMB substrate solution the concentration of Cortisol is inversely proportional to the optical density measured.
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    K Number
    K000043
    Device Name
    DRG AURICA ELISA TESTOSTERONE KIT
    Manufacturer
    DRG INTL., INC.
    Date Cleared
    2000-04-17

    (102 days)

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

    DRG INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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