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510(k) Data Aggregation

    K Number
    K023483
    Device Name
    KALAZAR DETECT
    Manufacturer
    INBIOS INTL., INC.
    Date Cleared
    2003-05-06

    (201 days)

    Product Code
    LOO
    Regulation Number
    866.3870
    Why did this record match?
    Product Code :

    LOO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kalazar Detect™ Test is a rapid immuno-chromatographic strip assay for the qualitative detection of antibodies to members of L. donovani complex in human serum. This test is intended for laboratory or professional in vitro diagnostic use only.
    Device Description
    Not Found
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