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Bruker Registers Mass Specs with Korean Regulators as Medical Devices for IVD Apps

NEW YORK, Aug. 10 (GenomeWeb News) - Bruker Daltonics has registered its autoflex II MALDI-TOF mass spectrometers as class I medical devices with the Korean Food and Drug Administration, the company said today.

 

The registration helps Bruker's customers obtain regulatory approval for mass spectrometry-based in vitro diagnostic methods they developed, according to the company.

 

The mass spectrometers are already being used by GeneMatrix of Korea for molecular diagnostics applications, which the company offers to medical centers and university hospitals in Korea, according to Bruker. The autoflex II instruments are also part of Bruker's ClinProt system for peptide and protein biomarker profiling.

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