BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COVID-19 IgG AccuLite® CLIA Test System (Ref 11975-300A and 11975-300B)

    Reg #: 2020726 · FEI: 2020726 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    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
    Reagent, Coronavirus Serological QKO

    Proprietary Names

    COVID-19 IgG AccuLite® CLIA Test System (Ref 11975-300A and 11975-300B) COVID-19 IgG S1-RBD AccuBind® ELISA Test System (Ref 12525-300A and 12525-300B) COVID-19 IgA AccuBind® ELISA Test System (Ref 11825-300A and 11825-300B) COVID-19 IgM AccuLite® CLIA Test System (Ref 11775-300A and 11775-300B) COVID-19 IgM AccuBind® ELISA Test System (Ref 11725-300A and 11725-300B) COVID-19 IgG S1-RBD AccuLite® CLIA Test System (Ref 12575-300A and 12575-300B) COVID-19 IgG AccuBind® ELISA Test System (Ref 11925-300A and 11925-300B) COVID-19 IgA AccuLite® CLIA Test System (Ref 11875-300A and 11875-300B)

    Establishment Types

    Manufacture Device in the United States for Export Only