BEUDAMED
    FDA Registration Active 🇺🇸 United States

    QuickVue At-Home OTC COVID-19 Test

    Reg #: 2250051 · FEI: 2250051 · 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
    2250051
    FEI Number
    2250051
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1001 US Highway 202
    City
    RARITAN
    State
    NJ
    ZIP
    08869
    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

    Complaint File Establishment per 21 CFR 820.198