BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ultra Trak Pro Control Solution

    Reg #: 3006493142 · FEI: 3006493142 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Zenith Diagnostics dba Vertex Diagnostics
    Registration Number
    3006493142
    FEI Number
    3006493142
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2420 E Oakton St Ste X
    City
    Arlington Heights
    State
    IL
    ZIP
    60005
    Country
    US

    Regulatory Submissions

    510(k) Number
    K093724

    Owner / Operator

    Firm Name
    Zenith Diagnostics
    Operator Number
    10021860
    Address
    2420 East Oakton St, Unit x
    City
    Arlington Heights
    State
    IL
    Postal Code
    60005
    Country
    US
    Correspondent
    Suri Asal

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    Ultra Trak Pro Control Solution

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility