BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LIAISON Lyme Total Antibody Plus

    Reg #: 2182595 · FEI: 2182595 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DIASORIN INC.
    Registration Number
    2182595
    FEI Number
    2182595
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1951 Northwestern Ave
    City
    Stillwater
    State
    MN
    ZIP
    55082
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202573

    Owner / Operator

    Firm Name
    DiaSorin Inc.
    Operator Number
    9051149
    Address
    1951 Northwestern Ave
    City
    Stillwater
    State
    MN
    Postal Code
    55082
    Country
    US
    Correspondent
    Mari Meyer

    Products

    Device Name Product Code
    Assayed Quality Control Material For Clinical Microbiology Assays QCH
    Reagent, Borrelia Serological Reagent LSR

    Proprietary Names

    LIAISON Lyme Total Antibody Plus LIAISON Lyme IgM Control LIAISON Lyme IgM

    Establishment Types

    Manufacture Medical Device