BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    RIDASCREEN NOROVIRUS 3RD GENERATION EIA

    K Number: DEN110001 · Decision Feb 23, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    7

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    Basic Information

    Device Name
    RIDASCREEN NOROVIRUS 3RD GENERATION EIA
    K Number
    DEN110001
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    866.3395
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    R-Biopharm AG
    Date Received
    February 16, 2011
    Decision Date
    February 23, 2011
    Product Code
    OUC
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OUC Norovirus Serological Reagent

    Other Clearances by R-Biopharm AG

    K Number Device Name
    K171511 RIDA GENE Norovirus GI/GII