BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Urine InstaTest™ -Urine reagent strip

    Reg #: 2029372 · FEI: 1000306617 · Expires 2025
    View on FDA
    Products
    10
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    10

    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
    K970250

    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
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Test, Urine Leukocyte LJX
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Blood, Occult, Colorimetric, In Urine JIO
    Refractometer For Clinical Use JRE
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Electrolyte Controls (Assayed And Unassayed) JJR
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL

    Proprietary Names

    Urine InstaTest™ -Urine reagent strip

    Establishment Types

    Manufacture Medical Device