BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ImmunoDOT DNA/ENA Autoimmunity Screening Panel

    Reg #: 2027113 · FEI: 2027113 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GENBIO
    Registration Number
    2027113
    FEI Number
    2027113
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    15222 AVE. OF SCIENCE, Suite A
    City
    San Diego
    State
    CA
    ZIP
    92128
    Country
    US

    Regulatory Submissions

    510(k) Number
    K924843

    Owner / Operator

    Firm Name
    Innominata dba GenBio
    Operator Number
    2027113
    Address
    15222 AVE. OF SCIENCE, SUITE A, --
    City
    San Diego
    State
    CA
    Postal Code
    92128
    Country
    US
    Correspondent
    Fred E Adler

    Products

    Device Name Product Code
    Extractable Antinuclear Antibody, Antigen And Control LLL

    Proprietary Names

    ImmunoDOT DNA/ENA Autoimmunity Screening Panel

    Establishment Types

    Manufacture Medical Device