MD HPLC, MD Mass Spec, and Software Receive IVDD CE-Marking

The in vitro diagnostics device (IVDD) CE marking for the two high-performance instruments and software enables a combined system with the high accuracy of LC-MS to now be available to clinical laboratories in Europe for general IVD use.

Thermo Fisher Scientific (Waltham, MA, USA) has received the CE marking for its Thermo Scientific Prelude MD HPLC, Endura MD mass spectrometer, and ClinQuan MD software. Clinical laboratories in Europe now have access to a high-performance liquid chromatograph, mass spectrometer, and LC-MS software designed and manufactured for analyzing patient samples as components of laboratory-developed IVD tests.


"We're strongly committed to bringing the advantages of LC-MS to the clinical market," said Bradley Hart, strategic director, life sciences mass spectrometry, clinical markets, Thermo Fisher, “These three products are part of a larger initiative to make mass spectrometry more useful and accessible to clinicians.”

The Prelude MD HPLC provides automated sample cleanup and two channels of HPLC separation for greater productivity and certainty from laboratory-developed clinical diagnostic tests. Developing IVD tests with the Endura MD MS provides excellent sensitivity, quantitative performance, and robustness with built-in usability to help deliver more value and worry-free results.

The products were exhibited at the 2nd Annual European Conference on Clinical Mass Spectrometry, MSACL EU 2015 (September 8-11, Salzburg, Austria).

Related Links:
Thermo Fisher Scientific
Thermo Fisher Posters & Products presented at MSACL EU 2015
MSACL EU 2015 Conference