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In the XIX European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Bruker Daltonics has announced that its product line MALDI Biotyper for microbial identification in clinical microbiology has obtained the CE mark for in vitro diagnostics with a Statement of Compliance as required by Directive 98/79/EC of the European Union on medical devices for in vitro diagnosis.

ECCMID In 2008, Bruker Daltonik GmbH had already announced the alignment of its quality management system to ISO 13485, which governs the design, development, production, sale, distribution, installation and servicing Sales of instruments and systems for in vitro diagnosis.

In recent months, Bruker has organized and carried out extensive studies on evaluation of the product line MALDI Biotyper at several prestigious centers of clinical microbiology. One of our partners in these clinical trials is the Laboratory Limbach, Heidelberg (Germany), which are more than 25 clinical laboratories and private partners around the country and Germany. We have also conducted clinical trials with the German Max von Pettenkofer Institute, located in Munich.

In testing, has confirmed the overall accuracy of identification of different microbial groups. Similarly, a test in extreme conditions has demonstrated the wide applicability of MALDI Biotyper in a wide variety of different microorganisms. This test has also shown that the product line MALDI Biotyper can be applied to all mass spectrometers Bruker MALDI-TOF-linear with the CE mark in vitro diagnostic, as the instrument computer Microflex TM and TM Autoflex standing and high-capacity measurement. Outside the European Union, the product line MALDI Biotyper is only available for research purposes.