BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    LIOFILCHEM S.R.L.

    Reg #: 3012389632 · FEI: 3012389632 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    36
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    LIOFILCHEM S.R.L.
    Registration Number
    3012389632
    FEI Number
    3012389632
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Via Scozia, Zona Industriale
    City
    Roseto degli Abruzzi Teramo
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K243202

    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

    US Agent

    Business Name
    Laboratory Specialists, Inc.
    Contact Name
    Anthony DiFranco
    Address
    26214 CENTER RIDGE RD
    City
    WESTLAKE
    State
    OH
    ZIP
    44145
    Country
    US
    Email
    [email protected]
    Phone
    440 5035887

    Products

    Device Name Product Code
    Manual Antimicrobial Susceptibility Test Systems JWY
    Transport Medium, Notified Per The Vtm Guidance QMC
    Panels, Test, Susceptibility, Antimicrobial LTT
    Susceptibility Test Discs, Antimicrobial JTN
    Culture Media, Non-Propagating Transport JSM

    Proprietary Names

    MTS Ceflobiprole 002-32 ug/ml MTS™ (MIC Test Strip) Ceftazidime 016-256 ?g/mL MTS™ (MIC Test Strip) Tedizolid 002-32 ?g/mL MTS™Levofloxacin 002-32 ug/mL MTS™ (MIC Test Strip) Meropenem-vaborbactam 016/8-256/8 ?g/mL MTS Lefamulin 016-256 ug/mL MTS Aztreonam-Avibactam 016/4 - 256/4 ug/ml. MTS Gentamicin 016 - 256 ug/mL MTS™(MIC Test Strip) Plazomicin 016-256 ?g/mL MTS™ (MIC Test Strip) Dalbavancin 002-32 ?g/mL MTS™ (MIC Test Strip) Meropenem 002-32 ?g/mL MTS Imipenem-relebactam 002/4 - 32/4 ug/mL MTS™ (MIC Test Strip) Telavancin 016-256 ?g/mL MTS™ (MIC Test Strip) Penicillin G 002-32 ?g/mL VTM MTS Ampicillin-sulbactam 016/008-256/128 ug/mL MTS Ciprofloxacin 002 - 32 ug/mL ComASP Cefiderocol 008-128 MTS Piperacillin-tazobactam 0016/4-256/4 ug/mL MTS™ (MIC Test Strip) Delafloxacin 002-32 ?g/mL MTS™ ( MIC Test Strip) Erythromycin 016-256 ?g/mL MTS Gepotidacin 016-256 ug/mL MTS Tetracycline 016 - 256 ug/mL Sulopenem disc 2 ug MTS™ (MIC Test Strip) Omadacycline 002-32 ?g/mL MTS™ (MIC Test Strip) Ceftolozane-tazobactam 016/4-256/4 ?g/mL MTS Doxycycline 016-256 ug/mL MTS™ (MIC Test Strip) Eravacycline 002-32 ?g/mL Ceftobiprole BPR 5 ug DISC MTS Sulbactam-Durlobactam 004/4-64/4 ug 1mL (SUD) MTS™ (MIC Test Strip) Azithromycin 016-256 ?g/mL MTS™ (MIC Test Strip) Ceftazidime-avibactam 016/4-256/4 ?g/mL MTS™ (MIC Test Strip) Linezolid 016-256 ?g/mL MTS™ (MIC Test Strip) Vancomycin 016-256 ?g/mL MTS Imipenem 016 - 256 ug/mL MTS™ (MIC Test Strip) Clindamycin 016-256 ?g/mL

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device