BEUDAMED
    Product Code: NWY FDA not classified

    Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies

    Unknown

    The Test, Qualitative, Detection of Dengue IgM and IgG Antibodies (product code NWY) is an in vitro diagnostic device intended for the qualitative detection of IgM and IgG antibodies to dengue virus in human serum, plasma, or whole blood, aiding in the diagnosis of dengue infection. The device is not classified (Class N / FDA not classified), reviewed by the Microbiology panel, and has not yet been assigned a formal device class through the classification process. It carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    0
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    NWY
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    MI
    Submission Type
    3

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Intended for the detection of IgM and IgG antibodies to dengue virus in human serum, plasma or whole blood.

    Unclassified Reason

    3

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.