BEUDAMED
    Product Code: QTU FDA not classified

    Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests

    Unknown
    View on FDA
    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    QTU
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    MI
    Submission Type
    7

    Device Characteristics

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

    Definition

    Antigen-based in vitro diagnostic devices for the detection of non-variola Orthopoxvirus or monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens-EXPORT ONLY

    Unclassified Reason

    3

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.