Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K964687
    Device Name
    N LATEX CRP MONO REAGENT
    Date Cleared
    1996-12-16

    (90 days)

    Product Code
    Regulation Number
    866.5270
    Why did this record match?
    Product Code :

    DCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of C-reactive protein in human serum or plasma.
    Device Description
    The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of C-reactive protein in human serum or plasma. In the proposed product polystyrene particles coated with mouse monoclonal antibodies to C-reactive protein are agglutinated when mixed with samples containing C-reactive proteins. The intensity of the resulting scattered light in the nephelometer is dependent upon the C-reactive protein content so that, by comparison to standards of known concentration the C-reactive protein content of a sample can be determined.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1