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510(k) Data Aggregation

    K Number
    K031296
    Device Name
    LIQUI-HEME GLYCO A1C ASSAY
    Manufacturer
    Date Cleared
    2004-10-15

    (541 days)

    Product Code
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIODIAGNOSTIC INTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BioDiagnostic Intl LIQUI-HEME Glycohemoglobin A1c Test kit is an In Vitro Diagnostic reagent for the quantitative determination of Glycohemoglobin A1c (HbA1c) in human whole blood. The concentration of the HbA1c and the concentration of the total hemoglobin are measured. Concentration of HbA1c is calculated as a percentage of the total hemoglobin concentration. Measurements of percentage HbA1c are effective in monitoring long term glucose control in individuals with diabetes mellitus. This application is intended for the Hitachi instrument and is to be used by suitably qualified personnel under appropriate clinical laboratory conditions. Further, this test kit also includes a set of six calibrators and bilevel (Human) Low and High controls, which are optional.
    Device Description
    The BioDiagnostic Intl LIQUI-HEME Glycohemoglobin A1c Test kit is an In Vitro Diagnostic reagent for the quantitative determination of Glycohemoglobin A1c (HbA1c) in human whole blood. The method claimed is an immunological assay. Both the concentration of the HbA1c and the concentration of the total hemoglobin are measured. Concentration of HbA1c is calculated as a percentage of the total hemoglobin concentration. This test kit also includes a set of six calibrators and bilevel (Human) Low and High controls, which are optional.
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