BEUDAMED
    FDA Registration Active 🇨🇳 China

    STAT Cup II One Step Drug Test

    Reg #: 3005345870 · FEI: 3005345870 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    W.H.P.M. Bioresearch & Technology Co., Ltd.
    Registration Number
    3005345870
    FEI Number
    3005345870
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building 9, No.9 Tianfu Street, Daxing District
    City
    BEIJING
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K052197

    Owner / Operator

    Firm Name
    W.H.P.M. Bioresearch & Technology Co., Ltd.
    Operator Number
    9076940
    Address
    Building 9, No.9 Tianfu Street,, Daxing District
    City
    BEIJING
    State
    CN-BJ
    Postal Code
    102629
    Country
    CN

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Enzyme Immunoassay, Benzodiazepine JXM
    Enzyme Immunoassay, Opiates DJG
    Gas Chromatography, Methamphetamine LAF
    Enzyme Immunoassay, Methadone DJR
    Enzyme Immunoassay, Barbiturate DIS
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG

    Proprietary Names

    STAT Cup II One Step Drug Test First Sign Drug of Abuse Screening Test STAT Cup One Step Drug Test STAT Cassette One Step Drug Test STAT Dip One Step Drug Test

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device