|[August 28, 2014]
REPLACING PHOTO Thermo Fisher Scientific Launches LC-MS-Based Class I Medical Devices
CHICAGO --(Business Wire)--
Please replace the photo (for release dated July 28, 2014) with the
accompanying corrected photo.
The Thermo Scientific Prelude MD HPLC instrument and the Thermo Scientific Endura MD mass spectrometer are new FDA Class 1 medical devices that are designed to be components of laboratory-developed tests for analyzing patient samples. (Photo: Business Wire)
The release reads:
THERMO FISHER SCIENTIFIC LAUNCHES LC-MS-BASED CLASS I MEDICAL DEVICES
HPLC, mass spectrometer and software designed for clinical analyses
Clinical laboratories now have access to a new high-performance liquid
chromatograph, mass spectrometer and LC-MS software designed and
manufactured as FDA Class I devices to be components of
laboratory-developed tests for analyzing patient samples.
The Thermo Scientific Prelude MD HPLC utilizes TurboFlow
technology to reduce manual sample clean-up steps and variability. The
instrument features two parallel channels to enhance sample throughput,
and the channels can run identical or different methods simultaneously.
The Themo Scientific Endura MD Mass Spectrometer is designed to
combine usability, excellent quantitative performance, sensitivity and
robustness for high-confidence LC-MS results. The instrument is built to
generate accurate, reliable quantitation over a wide range of sample
sizes and concentrations.
Thermo Scientific ClinQuan MD software is written to streamline
LC-MS workflows. It features three-tiered access to software functions
with permission levels for technicians, supervisors, and directors as
required by the Clinical Laboratory Improvement Amendments of 1988
(CLIA). Audit trails simplify recordkeeping and protect the integrity of
These products are making their debuts at the 2014 Annual Meeting &
Clinical Expo of the American Association for Clinical Chemistry,
McCormick Place, Chicago, booth 1221. Please visit www.thermoscientific.com/lcms-IVD
for more information.
"We're strongly committed to bringing the advantages of LC-MS to the
clinical market, and these three products are the first of a larger
initiative to make mass spectrometry more useful and accessible to the
clinician," said Dan Shine, president of chromatography and mass
spectrometry for Thermo Fisher Scientific.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science,
with revenues of $17 billion and 50,000 employees in 50 countries. Our
mission is to enable our customers to make the world healthier, cleaner
and safer. We help our customers accelerate life sciences research,
solve complex analytical challenges, improve patient diagnostics and
increase laboratory productivity. Through our four premier brands -
Thermo Scientific, Life Technologies, Fisher Scientific and Unity Lab
Services - we offer an unmatched combination of innovative technologies,
purchasing convenience and comprehensive support. For more information,
please visit www.thermofisher.com.
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