Bruker Daltonics obtains Russian Medical Device Registration

Bruker Daltonics Inc. (Billerica, Massachusetts) announced that it has obtained registration of its MALDI-TOF product line of microflex, autoflex TOF or TOF/TOF, and ultraflex TOF/TOF mass spectrometers as medical devices from the Ministry of Health and Social Development of the Russian Federation.

MALDI-TOF mass spectrometry is increasingly being applied as a clinical research tool in biomarker discovery, clinical proteomics, functional genomics, molecular imaging, and microorganism identification. Bruker Daltonics now has registered its flex series MALDI-TOF mass spectrometers as medical devices in the Russian Federation, to facilitate upcoming regulatory approvals of novel mass-spectrometry based upon in vitro diagnostic assays by its Russian customers.