BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CA 19-9 AccuLite® CLIA Test System (Ref 3975-300A and 3975-300B)

    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
    System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer NIG

    Proprietary Names

    CA 19-9 AccuLite® CLIA Test System (Ref 3975-300A and 3975-300B) CA 19-9 AccuBind® ELISA Test System (Ref 3925-300A and 3925-300B)

    Establishment Types

    Manufacture Device in the United States for Export Only