BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Easy@Home Urinary Tract Infection Test

    Reg #: 3014759506 · FEI: 3014759506 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TYROS BIOPHARMA INC.
    Registration Number
    3014759506
    FEI Number
    3014759506
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4702 Louis-B.-Mayer, Suite 305
    City
    Laval Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K063295

    Owner / Operator

    Firm Name
    Tyros Biopharma Inc.
    Operator Number
    10059257
    Address
    4702 Louis-B.-Mayer, Suite 305
    City
    Laval
    State
    Quebec
    Postal Code
    H7P 0L9
    Country
    CA

    US Agent

    Business Name
    QUARAS, LLC
    Contact Name
    Roshana Ahmed
    Address
    2101 Camino Rey
    City
    Fullerton
    State
    CA
    ZIP
    92833
    Country
    US
    Email
    [email protected]
    Phone
    657 2487361

    Products

    Device Name Product Code
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Test, Urine Leukocyte LJX

    Proprietary Names

    Easy@Home Urinary Tract Infection Test

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device