BEUDAMED
    FDA Registration Active 🇨🇳 China

    ACCU NEWS Drug Test Cup, Multi Drug 5 Urine Cup (THC-COC-MET-AMP-MOP)

    Reg #: 3008054239 · FEI: 3008054239 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    CORE TECHNOLOGY CO., LTD.
    Registration Number
    3008054239
    FEI Number
    3008054239
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 100, Building C, No.29, Life Park Road, Changping District
    City
    Beijing City
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K152590

    Owner / Operator

    Firm Name
    Core Technology Co., Ltd.
    Operator Number
    10044021
    Address
    Room 100, Building C, No.29, Life Park Road, Changping District
    City
    Beijing City
    State
    CN-BJ
    Postal Code
    102206
    Country
    CN
    Correspondent
    Chen Lizhu

    US Agent

    Business Name
    CorDx, Inc.
    Contact Name
    Vicky Huang
    Address
    9540 Waples St Unit C
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    858 8886916

    Products

    Device Name Product Code
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Amphetamine DKZ

    Proprietary Names

    ACCU NEWS Drug Test Cup, Multi Drug 5 Urine Cup (THC-COC-MET-AMP-MOP) ACCU NEWS Single Drug Screen Test, COC Test ACCU NEWS Single Drug Screen Test, THC Test ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5 Test Panel (THC-COC-MET-AMP-MOP) TyFast Drug Screening Urine Card CorDx Drug Screening Test Card TyFast Drug Screening Urine Cup CorDx Drug Screening Urine Cup

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)