Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012389632

FEI Number

3012389632

Entity Name

LIOFILCHEM S.R.L.

City/State/Country

Roseto degli Abruzzi Teramo, IT

Establishment Address

Via Scozia, Zona Industriale, Roseto degli Abruzzi Teramo 64026, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Liofilchem S.R.L. (Owner Number: 10052223)

Owner / Operator Contact Address

Via Scozia, Zona Industriale, Roseto degli Abruzzi, IT-TE 64026, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K170892

PMA Number

N/A

All Registered 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 MTSLevofloxacin 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) Tedizolid 002-32 ?g/mL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2025-03-17
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2017-02-27
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2018-05-22
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2018-12-21
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2017-12-20
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2020-04-07
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2025-12-20
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2019-03-22
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2018-08-03
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2016-06-30
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2017-01-19
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2019-08-23
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2017-03-24
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2018-09-14
QMC	Transport Medium, Notified Per The Vtm Guidance	Microbiology	Class 1	866.2390	2021-03-19
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2019-11-01
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2019-03-20
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2023-05-26
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-05-26
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2021-10-21
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2017-08-01
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2017-09-28
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2026-04-27
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2019-01-11
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2025-09-02
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2018-12-14
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2016-08-29
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2019-05-30
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2018-11-02
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2025-07-03
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2025-08-26
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2018-04-05
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2017-06-13

Official Correspondent

No official correspondent registered.

US Agent Details

Anthony DiFranco Business: Laboratory Specialists, Inc. Email: anthdif@aol.com Phone: (440) 5035887

Related Public Records

Same Entity

Liofilchem S.R.L.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013661582	Liofilchem, Inc.	Waltham, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K944753	Radiometer America, Inc.	SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP	1995-02-24
K010508	Pasco Laboratories, Inc.	PASCO MIC AND MIC/ID PANELS	2001-04-23
K111394	Siemens Healthcare Diagnostics, Inc.	MICROSCAN MICROSTEP	2011-06-22
K002664	Hardy Diagnostics	HARDYDISK LEVOFLOXACIN, 5MCG	2000-10-26

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1530126	Remel Cleveland, A Division of Remel Inc.	Oakwood Village, OH, US
3013661582	Liofilchem, Inc.	Waltham, MA, US
8021914	TREK DIAGNOSTIC SYSTEMS, LTD.	East Grinstead West Sussex, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012389632. Last updated year: 2026. Please use registration number 3012389632 when referencing this establishment in official correspondence.