NEW YORK (GenomeWeb News) – Promega said today that its Maxwell 16 system for DNA-based tests has received the CE Mark, enabling it to be marketed for diagnostic use throughout the European Union.

 

Madison, Wis.-based Promega said that the CE Mark would be particularly helpful for European labs conducting molecular pathology and transplant HLA to be compliant with in vitro diagnostic directives in their countries. The firm noted that the system already meets general purpose medical device requirements in the US.