Bruker Daltonics obtains Russian Medical Device Registration

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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.

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.

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