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510(k) Data Aggregation

    K Number
    K994356
    Device Name
    IMMUNOCYT
    Manufacturer
    Date Cleared
    2000-02-23

    (62 days)

    Product Code
    Regulation Number
    864.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOCURE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ImmunoCyt is a qualitative direct immunocytofluorescence assay intended for use in conjunction with cytology to increase the overall sensitivity for the detection of tumor cells exfoliated in the urine of patients previously diagnosed with bladder cancer. ImmunoCyt is indicated for use as an aid in the management of bladder cancer in conjunction with urinary cytology and cystoscopy.
    Device Description
    ImmunoCyt is an in vitro diagnostic device that contains a solution of three monoclonal antibodies. Two antibodies are reactive to epitopes selectively detected on a mucin found in bladder cancer cells, and one antibody reacts with a bladder cancer-associated glycosylated form of the carcinoembryonic antigen. The antibodies are coupled with fluorescent markers. This solution is used to detect tumor cells exfoliated in the urine of bladder cancer patients. ImmunoCyt also contains a sample fixative and a blocking solution, as well as positive and negative control cells.
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