BEUDAMED
    Product Code: QKO FDA not classified

    Reagent, Coronavirus Serological

    Unknown

    The Reagent, Coronavirus Serological is a not-classified in vitro diagnostic device intended for the qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens, developed in the context of the COVID-19 public health emergency. It has no assigned regulation number and is reviewed by the Microbiology panel. The product code is QKO. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    59
    Registration Numbers
    59
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    QKO
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    MI
    Submission Type
    8

    Device Characteristics

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

    Definition

    The qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens.

    Unclassified Reason

    11

    FEI Numbers

    This FDA classification entry is associated with 59 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 59 registration numbers. Click on an entry to view related FDA registrations.