Solutions for microbiology
About LIOFILCHEM®
Liofilchem® products are used in clinical and industrial laboratories in more than 150 countries worldwide.
Since 1983, Liofilchem® has been developing and manufacturing reliable, high-quality microbiology products. Liofilchem® is committed to combating the global spread of antimicrobial resistance and collaborates with leading international pharmaceutical organizations to develop diagnostic tools for antimicrobial susceptibility testing, such as MTS™ (MIC Test Strips), antibiotic discs, broth microdilution and agar dilution panels, rapid phenotypic tests, and chromogenic culture media.
Liofilchem also produces dehydrated and ready-to-use culture media, biochemical identification galleries, swabs and transport media, dip-slides and contact slides, biological indicators for sterilization processes, lyophilized organisms, as well as a wide range of other devices for manual and phenotypic microbiology.
Quality system Liofilchem
Liofilchem is certified by TÜV Süd to ISO 9001 for the quality management, to ISO 13485 as manufacturer of IVD (in-vitro diagnostics medical device) and to the MDSAP scheme (Medical Device Single Audit Program) for the sale of IVD (in-vitro diagnostic medical devices) in Australia, Brazil, Canada, Japan and the United States.
Liofilchem has obtained the EU Quality Management System Certificate (IVDR) pursuant to Regulation (EU) 2017/746 on in-vitro Diagnostic Medical Devices, Annex IX Chapters I and III (Class C and B Devices excluding self/near-patient-testing and Companion Diagnostics).
CERTIFICATE :
- EU Quality Management System Certificate (IVDR)
- ISO 13485:2016 MDSAP
- UNI EN ISO 9001:2015
- UNI EN ISO 13485:2016
- ISO/IEC 17025:2017
- ISO 45001:2018
- UNI EN ISO 9001:2015
PORTFOLIO
Microbiology Product
Services for the pharmaceutical industry
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MTS™ (MIC Test Strip)
The Liofilchem® MIC Test Strips is a quantitative assay for determining the Minimum Inhibitory Concentration (MIC) of antimicrobial agents against microorganisms to indicate appropriate patient treatment and for identifying resistance patterns.
