In Vitro Diagnostic Device
AB SCIEX 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. The 3200MD series is the first of a family of in vitro diagnostic devices that AB SCIEX plans to roll out. 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.
AB SCIEX, 877-740-2129, www.absciex.com