AB SCIEX Announces Company’s First In Vitro Diagnostic Device
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AB SCIEX has introduced the AB SCIEX API 3200MD™ and 3200MD QTRAP® LC/MS/MS systems, two devices that can be used to analyze trace levels of multiple compounds in human samples for diagnostic purposes.
Mass spectrometry is an analytical technology that has the potential to improve the quality of results for use in clinical diagnostics, while reducing costs compared to other technologies.
“Clinical diagnostics is the new frontier for mass spectrometry,” said Rainer Blair, President of AB SCIEX. “The introduction of the 3200MD series is a major milestone for AB SCIEX itself in response to the demand in clinical settings for mass spectrometers as medical devices that meet regulatory requirements.”
The 3200MD series is the first of a family of in vitro diagnostic devices that AB SCIEX plans to roll out around the world in the future.
The intended use of these devices is to identify inorganic or organic compounds in human specimens for clinical use.
The introduction of this new family of in vitro diagnostic devices follows up AB SCIEX’s announcement in 2012 of obtaining ISO 13485:2003 certification.
ISO 13485:2003 is an ISO standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
