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    K Number
    K060452
    Device Name
    ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
    Manufacturer
    NEO-GENESIS
    Date Cleared
    2007-03-13

    (385 days)

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

    NEO-GENESIS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accuwell" 17α-Hydroxyprogesterone EIA Kit is designed for the quantitative measurement of 17α-Hydroxyprogesterone (17-OHP) concentrations in neonatal blood samples that have been collected onto Whatman 903® specimen collection paper. The results are used to screen newborns for classical congenital adrenal hyperplasia (CAH).
    Device Description
    The Accuwell" 17a-Hydroxyprogesterone EIA Kit is a competitive solid phase enzyme immunoassay (ElA) for the quantitative measurement of 17«-Hydroxyprogesterone (17-OHP) concentrations in neonatal blood samples that have been collected onto Whatman S&S 903" specimen collection paper. Standard control, and unknown dried blood spot sample discs are added to specified wells in a 90-well microplate coated with antiserum specific for 17-OHP.
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