BEUDAMED
    FDA Registration Active 🇺🇸 United States

    THE BINDING SITE, INC.

    Reg #: 2083566 · FEI: 2083566 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    THE BINDING SITE, INC.
    Registration Number
    2083566
    FEI Number
    2083566
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    9606 Kearny Villa Rd
    City
    SAN DIEGO
    State
    CA
    ZIP
    92126
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250549

    Owner / Operator

    Firm Name
    THE BINDING SITE, INC.
    Operator Number
    2083566
    Address
    9606 Kearny Villa Road, --
    City
    San Diego
    State
    CA
    Postal Code
    92126
    Country
    US
    Correspondent
    Damon - Loya

    Products

    Device Name Product Code
    Lambda, Antigen, Antiserum, Control DEH
    Kappa, Antigen, Antiserum, Control DFH

    Proprietary Names

    Optilite Freelite Mx Kappa Free Kit Optilite® Freelite® Kappa Free Kit Optilite® Freelite® Lambda Free Kit Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems Freelite® Human Lambda Free Kit for use on the Roche cobas® c Systems Optilite Freelite Mx Lambda Free Kit

    Establishment Types

    Manufacture Medical Device