BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MTS™Levofloxacin 002-32 ug/mL

    Reg #: 3013661582 · FEI: 3013661582 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Liofilchem, Inc.
    Registration Number
    3013661582
    FEI Number
    3013661582
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    465 Waverley Oaks Rd. Suite 317
    City
    Waltham
    State
    MA
    ZIP
    02452
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183115

    Owner / Operator

    Firm Name
    Liofilchem S.R.L.
    Operator Number
    10052223
    Address
    Via Scozia, Zona Industriale
    City
    Roseto degli Abruzzi
    State
    Teramo
    Postal Code
    64026
    Country
    IT

    Products

    Device Name Product Code
    Manual Antimicrobial Susceptibility Test Systems JWY

    Proprietary Names

    MTS™Levofloxacin 002-32 ug/mL

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198