BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FastPack TPSA Immunoassay

    Reg #: 2032087 · FEI: 3003355251 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    QUALIGEN, INC.
    Registration Number
    2032087
    FEI Number
    3003355251
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2042 CORTE DEL NOGAL
    City
    CARLSBAD
    State
    CA
    ZIP
    92011
    Country
    US

    Regulatory Submissions

    510(k) Number
    K003094

    Owner / Operator

    Firm Name
    QUALIGEN, INC.
    Operator Number
    9040045
    Address
    2042 CORTE DEL NOGAL, --
    City
    Carlsbad
    State
    CA
    Postal Code
    92011
    Country
    US
    Correspondent
    Scott A Doyle

    Products

    Device Name Product Code
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ

    Proprietary Names

    FastPack TPSA Immunoassay

    Establishment Types

    Manufacture Medical Device