BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Anti-CCP IgG AccuBind® ELISA Test System (Refs 12725-300A 12725-300B)

    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

    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
    Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) NHX

    Proprietary Names

    Anti-CCP IgG AccuBind® ELISA Test System (Refs 12725-300A 12725-300B) Anti-CCP IgG AccuLite® CLIA Test System (Refs 12775-300A 12775-300B)

    Establishment Types

    Manufacture Device in the United States for Export Only