Bruker Daltonik GmbH Receives ISO 13485 Certification for
Development, Manufacturing and Distribution of Mass Spectrometry Systems
for IVD
BARCELONA, Spain (Business Wire EON) April 18, 2008 --
Before the 18th European Congress of Clinical
Microbiology and Infectious Disease (ECCMID) opening here tomorrow,
Bruker Daltonics announces that it has received EN ISO 13485
certification for its German operations. This ISO 13485 certification is
an important milestone in the development of the Bruker Daltonics in
vitro diagnostics (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 BioTyper™ mass
spectrometry system is already being adopted in clinical microbiology,
and we are also very excited about our MALDI Molecular Imager™
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.”
He added, “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™
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 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: BRKR)
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) systems segment, and the
Advanced Supercon segment. For more information, please visit www.bruker.com
MULTIMEDIA GALLERY http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5660526
Post Comment:
Trackback URL: http://eon.businesswire.com/pingpr.php/RW1wdC1TcXVhLUNvdXAtSGFsZi1GYWx1LVplcm8=
Bookmark -
Del.icio.us |
Digg |
Furl It |
Spurl |
RawSugar |
Simpy |
Shadows |
Blink It |
My Web
|
