BEUDAMED
    FDA Registration Active 🇨🇳 China

    Amazewell™ Multi-Drug Urine Test Clicker Cup

    Reg #: 3017904598 · FEI: 3017904598 · Expires 2025
    View on FDA
    Products
    22
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    22

    Registration Details

    Registration Name
    Guangzhou Decheng Biotechnology Co., Ltd.
    Registration Number
    3017904598
    FEI Number
    3017904598
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road, Science City, Huangpu District
    City
    Guangzhou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K232659

    Owner / Operator

    Firm Name
    Guangzhou Decheng biotechnology co., Ltd.
    Operator Number
    10079520
    Address
    Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road, Science City, Huangpu District
    City
    Guangzhou
    State
    Guangdong
    Postal Code
    510663
    Country
    CN
    Correspondent
    haisheng Hu

    US Agent

    Business Name
    LSI International Inc
    Contact Name
    Joe Xia
    Address
    504E Diamond Ave.
    City
    Gaithersburg
    State
    MD
    ZIP
    20877
    Country
    US
    Email
    [email protected]
    Phone
    240 5057880

    Products

    Device Name Product Code
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Benzodiazepine, Over The Counter NFV
    Test, Opiates, Over The Counter NGL
    Enzyme Immunoassay, Methadone DJR
    Test, Propoxyphene, Over The Counter QBF
    Test, Methamphetamine, Over The Counter NGG
    Enzyme Immunoassay, Propoxyphene JXN
    Enzyme Immunoassay, Benzodiazepine JXM
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Barbiturate DIS
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Test, Barbiturate, Over The Counter PTH
    Test, Methadone, Over The Counter PTG
    Test, Amphetamine, Over The Counter NFT
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Phencyclidine LCM
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Cannabinoid, Over The Counter NFW
    Test, Tricyclic Antidepressants, Over The Counter QAW

    Proprietary Names

    Amazewell™ Multi-Drug Urine Test Clicker Cup Dochek® Multi-Drug Urine Test Cup Xpeedy Multi-Drug Urine Test Cup EZCHECK® Multi-Drug Urine Test Clicker Cup AllSource DRUG DETECTOR BEB® Multi-Drug Urine Test Cup NOBLE Multi-Drug Urine Test Cup Dochek® Multi-Drug Urine Test Cup Rx magentacup™ Multi-Drug Urine Test Cup UScreen™ RAPID DRUG TEST CUP IDT Multi-Drug Urine Test Clicker Cup

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198