BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Anti-TPO AccuLite® CLIA Test System (Ref 1175-300A, 1175-300B)

    Reg #: 2020726 · FEI: 2020726 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MONOBIND, INC.
    Registration Number
    2020726
    FEI Number
    2020726
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    100 N. POINTE DR.
    City
    Lake Forest
    State
    CA
    ZIP
    92630
    Country
    US

    Regulatory Submissions

    510(k) Number
    K971835

    Owner / Operator

    Firm Name
    MONOBIND, INC.
    Operator Number
    2020726
    Address
    100 N. POINTE DR., --
    City
    Lake Forest
    State
    CA
    Postal Code
    92630
    Country
    US
    Correspondent
    Alicia Jerome

    Products

    Device Name Product Code
    Thyroglobulin, Antigen, Antiserum, Control DDC

    Proprietary Names

    Anti-TPO AccuLite® CLIA Test System (Ref 1175-300A, 1175-300B) Anti-TPO AccuBind® ELISA Test System(Ref 1125-300A, 1125-300B)

    Establishment Types

    Manufacture Medical Device