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    K Number
    K141827
    Device Name
    EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
    Manufacturer
    EUROIMMUN U.S., Inc.
    Date Cleared
    2015-04-17

    (284 days)

    Product Code
    DHN, PIV
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROIMMUN U.S., Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Instrument: The EUROPattern Microscope and Software is an automated system consisting of fluorescent microscope and software that acquires, interprets, stores and displays digital indirect immunofluorescence slides. The EUROPattern Microscope and Software can only be used with cleared or approved EUROIMMUN in vitro diagnostic assays that are indicated for use on the device. All suggested results obtained with the EUROPattern Microscope and Software must be confirmed by trained personnel. Assay: The EUROIMMUN IFA 40: HEp-20-10 EUROPattern is an indirect immunofluorescence antibody test for the qualitative or semiquantitative determination of IgG antibodies against antibody (ANA) in human serum with the EUROPattern Microscope and Software automated instrument. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.
    Device Description
    The EUROPattern Microscope and Software is an automated system consisting of fluorescent microscope and software that acquires, interprets, stores and displays digital indirect immunofluorescence slides.
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