NEW YORK (GenomeWeb) – Thermo Fisher Scientific said today that it has received the in vitro diagnostics device (IVDD) CE mark for its Thermo Scientific Prelude MD HPLC, Endura MD mass spectrometer, and ClinQuan MD software.
The approval makes these instruments, which constitute a full LC-MS system, available for general in vitro diagnostic use inEurope.
"We're strongly committed to bringing the advantages of LC-MS to the clinical market," Bradley Hart, strategic director, life sciences mass spectrometry, clinical markets, for Thermo Fisher, said in a statement. "These three products are part of a larger initiative to make mass spectrometry more useful and accessible to clinicians."
The move follows the company's announcement last year that it registered the same set of devices with the US Food and Drug Administration as Class I devices, making them available for clinical use in the US.