BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Rubella IgM AccuLite® CLIA Test System (Ref 6475-300A and 6475-300B)

    Reg #: 2020726 · FEI: 2020726 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    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
    Enzyme Linked Immunoabsorbent Assay, Rubella LFX

    Proprietary Names

    Rubella IgM AccuLite® CLIA Test System (Ref 6475-300A and 6475-300B) Rubella IgG AccuBind® ELISA Test System (Ref 6325-300A and 6325-300B) Rubella IgM AccuBind® ELISA Test System (Ref 6425-300A and 6425-300B) Rubella IgG AccuLite® CLIA Test System (Ref 6375-300A and 6375-300B)

    Establishment Types

    Manufacture Device in the United States for Export Only