BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    QuickVue At-Home OTC COVID-19 Test

    Reg #: 3012963943 · FEI: 3012963943 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Ortho Clinical Diagnostics, K.K.
    Registration Number
    3012963943
    FEI Number
    3012963943
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    East Tower 16F, GateCilty Osaki, Osaki 1-11-2,, Ortho Care Technical Support Center
    City
    Shinagawa-ku Tokyo
    Country
    JP

    Owner / Operator

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

    US Agent

    Business Name
    Ortho-Clinical Diagnostics, Inc.
    Contact Name
    Marlene Hanna
    Address
    100 Indigo Creek Drive
    City
    Rochester
    State
    NY
    ZIP
    14626
    Country
    US
    Email
    [email protected]
    Phone
    585 4534041

    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