BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Hevylite Human IgM Kappa Kit for use on Siemens BN II

    Reg #: 9614373 · FEI: 3002808340 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    The Binding Site Group Ltd.
    Registration Number
    9614373
    FEI Number
    3002808340
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 Calthorpe Road, Edgbaston
    City
    BIRMINGHAM
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K113823

    Owner / Operator

    Firm Name
    THE BINDING SITE
    Operator Number
    9008308
    Address
    8 Calthorpe Road,, Edgbaston
    City
    BIRMINGHAM
    State
    GB-NOTA
    Postal Code
    B15 1QT
    Country
    GB
    Correspondent
    Ned Merrick

    US Agent

    Business Name
    The Binding Site, Inc
    Contact Name
    Douglas Anderson
    Address
    6730 Mesa Ridge Road
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    858 2914550

    Products

    Device Name Product Code
    Method, Nephelometric, Immunoglobulins (G, A, M) CFN
    Immunoglobulin M Kappa Heavy And Light Chain Combined PDE
    Immunoglobulin M Lambda Heavy And Light Chain Combined PDF

    Proprietary Names

    Hevylite Human IgM Kappa Kit for use on Siemens BN II Hevylite Human IgM Lambda Kit for use on Siemens BN II

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device