BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FREND PSA

    Reg #: 3010324880 · FEI: 3010324880 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Alius Scientific,LLC
    Registration Number
    3010324880
    FEI Number
    3010324880
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    CALLE 246 PB54, COUNTRY CLUB
    City
    Carolina
    State
    PR
    ZIP
    00982
    Country
    US

    Regulatory Submissions

    510(k) Number
    K124056

    Owner / Operator

    Firm Name
    Alius Scientific, LLC
    Operator Number
    10072559
    Address
    Via Pedregal #10, Montecillo Court #3208
    City
    Trujillo Alto
    State
    PR
    Postal Code
    00976
    Country
    US
    Correspondent
    Richard Mangual

    Products

    Device Name Product Code
    Fluorometer, For Clinical Use KHO
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ

    Proprietary Names

    FREND PSA

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198