BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sofia 2

    Reg #: 3033751096 · FEI: 3033751096 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Ortho-Clinical Diagnostics, Inc.
    Registration Number
    3033751096
    FEI Number
    3033751096
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9975 Summers Ridge Rd
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162911

    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
    Fluorometer, For Clinical Use KHO
    Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus GQG

    Proprietary Names

    Sofia 2 Sofia 2 Installation Pack

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility