BEUDAMED
    FDA Registration Active 🇺🇸 United States

    One Step Lateral Flow Immunoassay

    Reg #: 2249781 · FEI: 3003204823 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Healgen Scientific LLC
    Registration Number
    2249781
    FEI Number
    3003204823
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    603 Heron Dr Ste 4
    City
    Swedesboro
    State
    NJ
    ZIP
    08085
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060760

    Owner / Operator

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

    Products

    Device Name Product Code
    Enzyme Immunoassay, Opiates DJG

    Proprietary Names

    One Step Lateral Flow Immunoassay

    Establishment Types

    Manufacture Medical Device