BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HCG AccuLite® CLIA Test System (Ref 875-300A and 875-300B)

    Reg #: 2020726 · FEI: 2020726 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    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, Human Chorionic Gonadotropin DHA

    Proprietary Names

    HCG AccuLite® CLIA Test System (Ref 875-300A and 875-300B) Free ?-hCG AccuLite® CLIA Test System (Ref 2075-300A and 2075-300B) HCG AccuBind® ELISA Test System (Ref 825-300A and 825-300B) HCG-XR AccuBind® ELISA Test System (Ref 8825-300A and 8825-300B) PAPP-A AccuLite® CLIA Test System (Ref 12675-300A and 12675-300B) Free ?-hCG AccuBind® ELISA Test System (Ref 2025-300A and 2025-300B) HCG-XR AccuLite® CLIA Test System (Ref 8875-300A and 8875-300B) PAPP-A AccuBind® ELISA Test System (Ref 12625-300A and 12625-300B) HCG Rapid AccuBind® ELISA Test System (Ref 3325-300A and 3325-300B)

    Establishment Types

    Manufacture Medical Device