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510(k) Data Aggregation

    K Number
    K970915
    Device Name
    DSL ESTRONE-SULFATE RIA
    Date Cleared
    1997-05-16

    (65 days)

    Product Code
    Regulation Number
    862.1280
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    Product Code :

    CGF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DSL 5400 Estrone-Sulfate RIA assay is intended for the quantitative determination of Estrone-Sulfate in human serum or EDTA plasma. The measurement of Estrone-Sulfate is used for in vitro diagnostic use in the diagnosis and treatment of numerous disorders, including infertility, amenormea, differentiation of primary and secondary ovarian malfunction, especially estrogen secreting testicular and ovarian tumors and precocious puberty in females.
    Device Description
    The RIA format is a competitive binding protein assay. Radio-labeled Estrone-Sulfate competes with un-labeled Estrone-Suffate in the serum or plasma sample for binding sites to the Estrone-Sulfate antiserum provided with the kit. Separation of free from bound Estrone-Sulfate is achieved by the addition of a second antibody containing goat anti-rabbit gamma clobulin serum with polvethviene giveol as a precipitating aid, centrifugation and decantation of the tubes. The resultant is analyzed in a gamma counter for bound counts per minute. The amount of radio-labeled Estrone-Sulfate bound to the antibody is inversely proportional to the concentration of the Estrone-Sulfate present in the sample.
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