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.
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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.
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The Maxwell 16 system can purify up to 16 DNA samples simultaneously in about 30 minutes with higher yield and greater consistency than similar methods, according to Promega. The instrument is a small bench-top unit that is roughly the size of an open laptop computer, the company said.