BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Anti-H. Pylori IgA AccuLite® CLIA Test System (Ref 1675-300A and 1675-300B)

    Reg #: 2020726 · FEI: 2020726 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    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
    Helicobacter Pylori LYR

    Proprietary Names

    Anti-H. Pylori IgA AccuLite® CLIA Test System (Ref 1675-300A and 1675-300B) Anti-H. Pylori IgM AccuLite® CLIA Test System (Ref 1575-300A and 1575-300B) Anti-H. Pylori IgG AccuBind® ELISA Test System (Ref 1425-300A and 1425-300B) Anti-H. Pylori IgM AccuBind® ELISA Test System (Ref 1525-300A and 1525-300B) Anti-H. Pylori IgA AccuBind® ELISA Test System (Ref 1625-300A and 1625-300B) Anti-H. Pylori IgG AccuLite® CLIA Test System (Ref 1475-300A and 1475-300B)

    Establishment Types

    Manufacture Device in the United States for Export Only