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Thermo Fisher Scientific Launches LC-MS-Based Class I Medical Devices

8/1/2014

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.

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 Thermo 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 results.

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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