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    K Number
    K973995
    Device Name
    RANDOX BILIRUBIN
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    1997-12-08

    (48 days)

    Product Code
    GIG
    Regulation Number
    864.7500
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    Product Code :

    GIG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Randox Laboratories Limited Bilirubin Test Kit is an in vitro diagnostic reagent for the quantitative determination of total and direct bilirubin in human serum and plasma. This method uses diazotized sulphanilic acid to measure bilirubin. To measure total bilirubin the sample is first incubated with caffeine which releases bilirubin from albumin. Direct (conjugate) bilirubin is determined in the absence of caffeine. Measurements of bilirubin are used in the diagnosis of liver disease, in the detection of haemolytic anaemia and to evaluate jaundice.
    Device Description
    The Randox Laboratories Limited Bilirubin Test Kit is an in vitro diagnostic reagent.
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