BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CorDx, Inc.

    Reg #: 3031823359 · FEI: 3031823359 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    30
    Establishment Types
    2
    Classifications
    14

    Registration Details

    Registration Name
    CorDx, Inc.
    Registration Number
    3031823359
    FEI Number
    3031823359
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5900 Windward Pkwy
    City
    Alpharetta
    State
    GA
    ZIP
    30005
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150063

    Owner / Operator

    Firm Name
    CorDx
    Operator Number
    10050914
    Address
    5900 Windward Pkwy
    City
    Alpharetta
    State
    GA
    Postal Code
    30005
    Country
    US
    Correspondent
    Amber Wen

    Products

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

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility