BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sofia 2 SARS Antigen+ FIA

    Reg #: 3021090658 · FEI: 3021090658 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    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

    Regulatory Submissions

    510(k) Number
    K233688

    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
    Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings QVF

    Proprietary Names

    Sofia 2 SARS Antigen+ FIA Sofia 2 SARS Antigen+ FIA Control Swab Set

    Establishment Types

    Manufacture Medical Device