BEUDAMED
    FDA Registration Active 🇨🇳 China

    CORE TECHNOLOGY CO., LTD.

    Reg #: 3008054239 · FEI: 3008054239 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    35
    Establishment Types
    3
    Classifications
    14

    Registration Details

    Registration Name
    CORE TECHNOLOGY CO., LTD.
    Registration Number
    3008054239
    FEI Number
    3008054239
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    29 Life Park Rd., #C100
    City
    Changping District Beijing
    Country
    CN

    Owner / Operator

    Firm Name
    Core Technology Co., Ltd.
    Operator Number
    10044021
    Address
    29 Life Park Rd., #C100
    City
    Changping District
    State
    Beijing
    Postal Code
    102206
    Country
    CN
    Correspondent
    Chen Lizhu

    US Agent

    Business Name
    CorDx, Inc.
    Contact Name
    Vicky Huang
    Address
    5900 Windward Pkwy
    City
    Alpharetta
    State
    GA
    ZIP
    30005
    Country
    US
    Email
    [email protected]
    Phone
    858 8886916

    Products

    Device Name Product Code
    Coronavirus Antigen Detection Test System. QKP
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Test, Methadone, Over The Counter PTG
    Test, Opiates, Over The Counter NGL
    Test, Propoxyphene, Over The Counter QBF
    Covid-19 Multi-Analyte Antigen Device QMN
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Amphetamine DKZ
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
    Test System, Nicotine, Cotinine, Metabolites MRS

    Proprietary Names

    CorDx COVID-19 Ag Test Genabio COVID-19 Rapid Self-Test Kit Coretests Ovulation Test Midstream Coretests Ovulation Test Strip ACCU NEWS Ovulation Test + Pregnancy Test Combo CorDx Tyfast Ovulation Test Strip CorDx Tyfast Ovulation Test + Pregnancy Test Combo Coretests Ovulation Test Cassette CorDx Tyfast Ovulation Test Cassette CorDx Tyfast Ovulation Test Midstream CorDx Tyfast Pregnancy Test Cassette ACCU NEWS Pregnancy Test Strip ACCU NEWS One Step hCG Pregnancy Test Strip ACCU NEWS Pregnancy Test Midstream ACCU NEWS One Step hCG Pregnancy Test Midstream ACCU NEWS One Step hCG Pregnancy Test Cassette ACCU NEWS Pregnancy Test Cassette CorDx Tyfast Pregnancy Test Midstream CorDx Tyfast Pregnancy Test Strip CorDx Tyfast Multi-Drug Rapid Test Cup CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test ACCU NEWS Single Drug Screen Test, COC Test ACCU NEWS Drug Test Cup, Multi Drug 5 Urine Cup (THC-COC-MET-AMP-MOP) ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5 Test Panel (THC-COC-MET-AMP-MOP) ACCU NEWS Single Drug Screen Test, THC Test TyFast Drug Screening Urine Card CorDx Drug Screening Urine Cup CorDx Drug Screening Test Card TyFast Drug Screening Urine Cup CorDx Tyfast FSH Rapid Test Cassette CorDx Tyfast FSH Rapid Test Strip CorDx Tyfast FSH Rapid Test Midstream CorDx Tyfast Cotinine (COT) Rapid Test Strip CorDx Tyfast Cotinine (COT) Rapid Test Cassette

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device