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510(k) Data Aggregation

    K Number
    K981226
    Device Name
    IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3
    Manufacturer
    DAKO DIAGNOSTICS LTD.
    Date Cleared
    1998-09-28

    (188 days)

    Product Code
    GQP, GOP
    Regulation Number
    866.3400
    Why did this record match?
    Product Code :

    GQP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMAGEN™ Parainfluenza virus Group (Types 1, 2 and 3) is a qualitative direct immunofluorescence test for the presumptive detection and confirmation of parainfluenza virus type 1, 2 and 3 antigens in respiratory specimens (nasopharyngeal aspirates) from paediatric populations and in cell culture preparations. The IMAGEN™ Parainfluenza virus Types 1. 2 and 3 is a qualitative direct immunofluorescence test for the presumptive detection and differentiation of parainfluenza virus type 1, 2 and 3 antigens respectively in respiratory specimens (nasopharyngeal aspirates) from paediatric populations and in cell culture preparations. A negative result obtained following direct staining of nasopharyngeal aspirates should be considered presumptive until confirmed by culture.
    Device Description
    IMAGEN™ Parainfluenza Virus Group (Types 1, 2 and 3) is for the detection and confirmation of the presence of Parainfluenza virus antigens in cell culture preparations and direct specimens (nasopharyngeal aspirates) from paediatric populations. A single reagent is provided which contains a mix of purified murine monoclonal antibodies specific to Parainfluenza virus types 1, 2 and 3, conjugated to fluorescein isothiocyanate (FITC). IMAGEN™ Parainfluenza Virus Types 1, 2 and 3 is for the detection and differentiation of Parainfluenza virus type 1, 2 and 3 antigens respectively in cell culture preparations and direct specimens (nasopharyngeal aspirates) from paediatric populations. Three individual reagents are provided which each contain a purified murine monoclonal antibody specific to either Parainfluenza virus type 1, 2 or 3, conjugated to fluorescein isothiocyanate (FITC). The technological characteristics of the IMAGEN ™ Parainfluenza Virus Group (Types 1, 2 and 3) and IMAGEN'''' Parainfluenza Virus Types 1, 2 and 3 differ from those of the Predicate Device in that they consist of directly FITC labelled type specific mouse monoclonal antibodies which are used in a one step direct immunofluorescence technique.
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