AB Sciex this week said that its API 3200MD and 3200MD QTRAP mass spectrometers have received the EU CE-IVDD mark, allowing them to be sold in the EU for general in vitro diagnostic use including in hospitals and clinical diagnostic laboratories.
The announcement follows on the release in February of the 3200MD and 3200MD QTRAP in the US as US Food and Drug Administration Class I exempt medical devices (PM 2/15/2013).
"We are focused on meeting the medical, technological and compliance needs of clinical diagnostic laboratories and hospitals," AB Sciex president Rainer Blair, said in a statement, adding that he expected the EU release of the devices to "simplify and accelerate [clinical] adoption of this powerful technology."
The company said that it plans to continue to release regulatory compliant mass spec systems around the world, pursuing a strategy of expanding the use of mass spec technology in clinical diagnostics.
The 3200MD and 3200MD QTRAP are slated to begin shipping in Europe by mid-June.