BEUDAMED
    FDA Registration Active 🇺🇸 United States

    2San Urinary Tract Infection (UTI) Test

    Reg #: 3025041446 · FEI: 3025041446 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    2SAN LLC
    Registration Number
    3025041446
    FEI Number
    3025041446
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1330 Avenue of the Americas
    City
    New York
    State
    NY
    ZIP
    10019
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231045

    Owner / Operator

    Firm Name
    2San LLC
    Operator Number
    10088220
    Address
    1330 Avenue of the Americas
    City
    New York
    State
    NY
    Postal Code
    10019
    Country
    US
    Correspondent
    Chelsea Tooze

    Products

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

    Proprietary Names

    2San Urinary Tract Infection (UTI) Test

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198