BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AZO Test Strips(R)

    Reg #: 1221895 · FEI: 1221895 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    i-Health, Inc.
    Registration Number
    1221895
    FEI Number
    1221895
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    a division of dsm-firmenich, 25 Bacon Road, Suite 102
    City
    Enfield
    State
    CT
    ZIP
    06082
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100024

    Owner / Operator

    Firm Name
    i-Health, Inc., a division of DSM-FIRMENICH
    Operator Number
    10026311
    Address
    2 Corporate Drive, Suite 445
    City
    Shelton
    State
    CT
    Postal Code
    06484
    Country
    US
    Correspondent
    Julie M Bagley

    Products

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

    Proprietary Names

    AZO Test Strips(R)

    Establishment Types

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