BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OneStep Single-Drug Urine RapiCard™/Single-Drug RapiDip™/Single-Drug RapiCup™ (Laboratory/POC)

    Reg #: 2029372 · FEI: 1000306617 · Expires 2025
    View on FDA
    Products
    12
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    11

    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
    K063545

    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
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Cannabinoids LDJ
    NCI
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Enzyme Immunoassay, Opiates DJG
    Test, Benzodiazepine, Over The Counter NFV
    Enzyme Immunoassay, Methadone DJR
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Barbiturate DIS
    Enzyme Immunoassay, Benzodiazepine JXM
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Phencyclidine LCM

    Proprietary Names

    OneStep Single-Drug Urine RapiCard™/Single-Drug RapiDip™/Single-Drug RapiCup™ (Laboratory/POC) Single-Drug Urine RapiCard™/Single-Drug RapiDip™/Single-Drug RapiCup™ (Laboratory/POC)

    Establishment Types

    Manufacture Medical Device