BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AFP AccuLite® CLIA Test System (Ref 1975-300A and 1975-300B)

    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
    Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment NSF

    Proprietary Names

    AFP AccuLite® CLIA Test System (Ref 1975-300A and 1975-300B) AFP/ CEA/ PSA VAST AccuBind® ELISA Test System (Ref 8425-300A and 8425-300B and 8425-300D and 8425-300E) AFP/ hCG/ uE3 VAST AccuLite® CLIA Test System (Ref 8575-300A and 8575-300B and 8575-300D and 8575-300E) AFP/ hCG/ uE3 VAST AccuBind® ELISA Test System (Ref 8525-300A and 8525-300B and 8525-300D and 8525-300E) AFP AccuBind® ELISA Test System (Ref 1925-300A and 1925-300B) AFP/ CEA/ PSA VAST AccuLite® CLIA Test System (Ref 8475-300A and 8475-300B and 8475-300D and 8475-300E)

    Establishment Types

    Manufacture Device in the United States for Export Only