AB SCIEX Announces In Vitro Diagnostic Devices CE Marked for Europe
News May 21, 2013
Meeting regulatory requirements to obtain the CE-IVDD mark for the new AB SCIEX API 3200MD™ and 3200MD QTRAP® LC/MS/MS systems* will provide European hospitals and clinical diagnostic laboratories the confidence to use these mass spectrometry-based systems to improve the quality of results in clinical analysis while reducing costs.
“We are focused on meeting the medical, technological and compliance needs of clinical diagnostic laboratories and hospitals,” said Rainer Blair, President of AB SCIEX. “The use of LC/MS/MS technology for clinical diagnostics has already been proven to deliver faster, more accurate results at lower cost compared to existing technologies. Now, we are bringing these benefits to Europe in a way that will simplify and accelerate adoption of this powerful technology.”
The announcement, made at the EuroMedLab conference in Milan, Italy follows on the heels of the company’s announcement of the family of 3200MD systems earlier this year. The 3200MD series is the company’s first of a family of in vitro diagnostic devices. The intended use of these devices is to identify inorganic or organic compounds in human specimens for clinical use.
AB SCIEX plans to continue to roll out regulatory-compliant systems around the world in the future. With these IVD devices, the company is delivering on its strategy to expand the use of its technology in clinical diagnostics, which is widely deemed a new frontier for mass spectrometry.
AB SCIEX has a two-decade track record of success in the clinical research (RUO) market. The company has excelled at advancing and simplifying LC/MS/MS technology, so it is easier for laboratories to adopt and utilize for routine analysis. The robustness and ease of use of the 3200 product line makes it a preferred instrument for research laboratories of all sizes. Now applying its expertise and experience to the IVD market, AB SCIEX is also expanding its service offerings to provide enhanced service and support specifically for clinical diagnostics.
The AB SCIEX API 3200MD™ and 3200MD QTRAP® LC/MS/MS systems are expected to ship in Europe by mid-June.
*Not available in every country.