BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Rapid One Opiates Test

    Reg #: 1320738 · FEI: 3000718556 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Healgen Scientific LLC
    Registration Number
    1320738
    FEI Number
    3000718556
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    122 Smith Rd
    City
    KINDERHOOK
    State
    NY
    ZIP
    12106
    Country
    US

    Regulatory Submissions

    510(k) Number
    K990820

    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
    Gas Chromatography, Morphine DMY
    Enzyme Immunoassay, Opiates DJG
    Gas Chromatography, Opiates DJF

    Proprietary Names

    Rapid One Opiates Test

    Establishment Types

    Manufacture Medical Device