BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PreScreen Plus DOA Test Cup/Dip card

    Reg #: 3009238284 · FEI: 3009238284 · Expires 2025
    View on FDA
    Products
    9
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    9

    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
    K153597

    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
    Enzyme Immunoassay, Amphetamine DKZ
    Gas Chromatography, Methamphetamine LAF
    Enzyme Immunoassay, Methadone DJR
    Enzyme Immunoassay, Barbiturate DIS
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Phencyclidine LCM
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Benzodiazepine JXM

    Proprietary Names

    PreScreen Plus DOA Test Cup/Dip card Prescreen Plus Mini DOA Test Cup/Dip Card ZeroChaos Drug Test Cup CRL Stat Drug Test Cup PreScreen Plus Mini DOA Test Cup/Dip card Drugconfirm Multi-Drug Urine Test Cup/Dip Smart Choice Multi-Panel DOA Test Cup/Dips Lakeshore Trade Multi Panel DOA rapid test dip card Lakeshore Trade Multi Panel DOA rapid test cup Lakeshore Trade Single Panel rapid test dip card

    Establishment Types

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