BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Solana GBS Assay

    Reg #: 1528450 · FEI: 1000122536 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Ortho-Clinical Diagnostics, Inc.
    Registration Number
    1528450
    FEI Number
    1000122536
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2005 East State Street, Suite 100
    City
    ATHENS
    State
    OH
    ZIP
    45701
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173250

    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
    Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test NJR

    Proprietary Names

    Solana GBS Assay

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device