LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    DEN180030
    Device Name
    QMS Plazomicin Immunoassay
    Manufacturer
    Microgenics Corporation
    Date Cleared
    2018-11-19

    (147 days)

    Product Code
    QDR
    Regulation Number
    862.3460
    Why did this record match?
    Product Code :

    QDR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QMS Plazomicin Immunoassay is intended for the quantitative determination of plazomicin in human K2-EDTA plasma on automated clinical chemistry analyzers. The assay results obtained should only be used as an aid in the management of patients with complicated urinary tract infection (cUTI) receiving plazomicin therapy. The assay should only be used in conjunction with information available from clinical evaluations and other diagnostic procedures.
    Device Description
    The OMS Plazomicin Immunoassay system is a homogeneous assay utilizing particle agglutination technology and it is based on the competitive binding principle. The assay consists of liquid ready-to-use reagents R1 (anti-plazomicin mouse monoclonal antibody) and R2 (plazomicin-coated microparticles).
    Ask a Question

    Page 1 of 1