BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5 Test Panel (THC-COC-MET-AMP-MOP)

    Reg #: 3031823359 · FEI: 3031823359 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    CorDx, Inc.
    Registration Number
    3031823359
    FEI Number
    3031823359
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5900 Windward Pkwy
    City
    Alpharetta
    State
    GA
    ZIP
    30005
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152590

    Owner / Operator

    Firm Name
    CorDx
    Operator Number
    10050914
    Address
    9540 Waples St Unit C
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US
    Correspondent
    Amber Wen

    Products

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

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device