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510(k) Data Aggregation

    K Number
    DEN060001
    Device Name
    PHICAL TEST
    Manufacturer
    GENOVA DIAGNOSTICS
    Date Cleared
    2006-04-26

    (34 days)

    Product Code
    NXO, CAL
    Regulation Number
    866.5180
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENOVA DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PhiCal™ test is a quantitative ELISA for measuring, in human stool, concentrations of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The PhiCal™ test can be used as an in vitro diagnostic to aid in the diagnosis of inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis, and to differentiate IBD from irritable bowel syndrome; when used in conjunction with other diagnostic testing and the total clinical picture.
    Device Description
    The PhiCal test assay consists of: microtiter plate coated with polyclonal rabbit antibodies for calprotectin (12 strips, 8 wells per strip); alkaline phosphatase labeled rabbit anti-calprotectin IgG in buffer with Proclin 300; substrate in buffer; 20X washing solution; 10X dilution solution with Proclin 300; 5X extraction solution with Proclin 300; 5 vials of calprotectin solution at concentrations of 6.25, 12.5, 25, 50 and 100 ng/mL; a low and a high control.
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