BEUDAMED
    FDA Registration Active 🇺🇸 United States

    QuickVue At-Home OTC COVID-19 Test

    Reg #: 3021090658 · FEI: 3021090658 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Ortho-Clinical Diagnostics, Inc.
    Registration Number
    3021090658
    FEI Number
    3021090658
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2285 Rutherford Road
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Owner / Operator

    Firm Name
    QuidelOrtho Corp.
    Operator Number
    2024674
    Address
    9975 Summers Ridge Road, --
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US

    Products

    Device Name Product Code
    Coronavirus Antigen Detection Test System. QKP

    Proprietary Names

    QuickVue At-Home OTC COVID-19 Test Sofia 2 SARS Antigen FIA Sofia SARS Antigen FIA QuickVue At Home COVID-19 QuickVue SARS Antigen Test VITROS SARS-COV-2 Antigen Reagent Pack EUA202928 VITROS SARS-COV-2 Antigen Calibrator EUA202928 CVS at-home Covid-19 Test Walgreens at-home Covid-19 Test VITROS SARS-COV-2 Antigen Controls EUA202928 VITROS SARS-COV-2 Extraction Buffer EUA202928

    Establishment Types

    Manufacture Medical Device