BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FSH AccuLite® CLIA Test System (Ref 475-300A, 475-300B)

    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

    Regulatory Submissions

    510(k) Number
    K972720

    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
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ

    Proprietary Names

    FSH AccuLite® CLIA Test System (Ref 475-300A, 475-300B) FSH AccuBind® ELISA Test System (Ref 425-300A, 425-300B) FSH/ hCG/ LH/ PRLs VAST AccuLite® CLIA Test System (Ref 8375-300A, 8375-300B, 8375-300D, 8375-300E) FSH/ hCG/ LH/ PRLs VAST AccuBind® ELISA Test System (Ref 8325-300A, 8325-300B, 8325-300D, 8325-300E)

    Establishment Types

    Manufacture Medical Device