Bruker Daltonik GmbH Receives ISO 13485 Certification for Development, Manufacturing and Distribution of Mass Spectrometry Systems for IVD.BARCELONA, Spain -- Before the 18th European Congress of Clinical Microbiology and Infectious Disease (ECCMID ECCMID European Society of Clinical Microbiology and Infectious Diseases ) opening here tomorrow, Bruker Daltonics announces that it has received EN ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 13485 certification for its German operations. This ISO 13485 certification is an important milestone in the development of the Bruker Daltonics in vitro diagnostics In vitro diagnostic (IVD) tests are medical tests conducted in a test tube, or more generally in a controlled environment outside a living organism. In vitro means in glass in Latin. (IVD) business, particularly in the fields of clinical proteomics, clinical microbiology and molecular imaging in pathology. Dr. Wolfgang Pusch, Assistant Vice President of the Bruker Daltonics Clinical Research Systems business, commented: "This is an important step forward for the further growth of our business. Our ISO 13485 certification now allows us to further develop several of our clinical research platforms towards IVD-CE certification and reimbursement: our MALDI MALDI Matrix-Assisted Laser Desorption/Ionization BioTyper[TM] mass spectrometry system is already being adopted in clinical microbiology, and we are also very excited about our MALDI Molecular Imager[TM] solution for molecular histology. Moreover, many of our customers are accelerating their peptide and protein biomarker discovery and validation efforts, and we expect the emergence of future IVD multimarker panels for clinical proteomics." Dr. Ulrich Weller, the Head of Microbiology at the Center for Laboratory Medicine and Hemostaseology at the Dr. med. Christiane Boogen clinical laboratory in Cologne, Germany, pointed out: "We have just recently introduced the Bruker MALDI BioTyper system in our clinical microbiology routine analysis. The market is certainly ready for such a next generation microbial identification approach. I see with great interest that Bruker Daltonics is committed to support the community of routine laboratories in microbiology and laboratory medicine with the necessary ISO 13485 quality management." About the Bruker MALDI BioTyper[TM] Bruker's dedicated research-only MALDI BioTyper solution enables identification, taxonomical classification or dereplication of microorganisms like bacteria, yeasts and fungi. Classification and identification of microorganisms is achieved reliably and fast using high-throughput MALDI-TOF MALDI-TOF Matrix Assisted Laser Desorption Ionization - Time of Flight mass spectrometry. Applications exist in clinical research, environmental and taxonomical research, as well as in food processing and in quality control. Bruker's robust method requires minimal sample preparation efforts and has very low costs per sample. ABOUT BRUKER CORPORATION (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : BRKR BRKR Breaker ) Bruker Corporation has recently become the parent company of the entire Bruker group of companies. Bruker Corporation now operates in two segments, the Life Science and Analytical (LSA LSA - Link State Advertisement ) systems segment, and the Advanced Supercon segment. For more information, please visit www.bruker.com |
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