BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine)

    Reg #: 3009238284 · FEI: 3009238284 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HEALGEN SCIENTIFIC LLC
    Registration Number
    3009238284
    FEI Number
    3009238284
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3818 Fuqua St
    City
    Houston
    State
    TX
    ZIP
    77047
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240949

    Owner / Operator

    Firm Name
    HEALGEN SCIENTIFIC LLC
    Operator Number
    10038461
    Address
    3818 Fuqua Street
    City
    Houston
    State
    TX
    Postal Code
    77047
    Country
    US

    Products

    Device Name Product Code
    Test, Opiates, Over The Counter NGL

    Proprietary Names

    Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine) Healgen® Accurate Fentanyl Rapid Test Strip (Urine) 205 Medical LLC D-Tect Fentanyl Test (Strip) Healgen® Accurate Rapid Fentanyl Test Strip (Urine) Healgen® Accurate Fentanyl Rapid Test Cassette (Urine) Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine) Healgen® Accurate Rapid Fentanyl Test Cassette (Urine)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198