BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OneStep InstaTest HCG Combo Urine/Serum RapiCard

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

    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
    K984077

    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
    Visual, Pregnancy Hcg, Prescription Use JHI

    Proprietary Names

    OneStep InstaTest HCG Combo Urine/Serum RapiCard

    Establishment Types

    Manufacture Medical Device