BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Liofilchem, Inc.

    Reg #: 3013661582 · FEI: 3013661582 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    36
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    Liofilchem, Inc.
    Registration Number
    3013661582
    FEI Number
    3013661582
    Status
    Active
    Expiry Year
    2026
    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
    Susceptibility Test Discs, Antimicrobial JTN
    Panels, Test, Susceptibility, Antimicrobial LTT
    Culture Media, Non-Propagating Transport JSM
    Transport Medium, Notified Per The Vtm Guidance QMC

    Proprietary Names

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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device