BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OneStep Mult-Drug Combination Urine RapiCup™ -OTC Use/ Prescription Use

    Reg #: 2029372 · FEI: 1000306617 · Expires 2025
    View on FDA
    Products
    22
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    22

    Registration Details

    Registration Name
    Diagnostic Automation/ Cortez Diagnostics Inc,.
    Registration Number
    2029372
    FEI Number
    1000306617
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    21250 Califa St Suite 102 and 116
    City
    Woodland Hills
    State
    CA
    ZIP
    91367
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173303

    Owner / Operator

    Firm Name
    Diagnostic Automation /Cortez Diagnostics Inc.
    Operator Number
    9011974
    Address
    21250 Califa St,, SUITE 102 and 116
    City
    Woodland Hills
    State
    CA
    Postal Code
    91367
    Country
    US
    Correspondent
    PAUL - SHAW

    Products

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

    Proprietary Names

    OneStep Mult-Drug Combination Urine RapiCup™ -OTC Use/ Prescription Use Mult-Drug Combination Urine RapiCup™ -OTC Use/ Prescription Use

    Establishment Types

    Manufacture Medical Device