FDAnews
www.fdanews.com/articles/72499-preanalytix-paxgene-blood-rna-system

PreAnalytiX PAXgene Blood RNA System

May 19, 2005

PreAnalytiX, a joint venture between QIAGEN and BD (Becton, Dickinson), announced that it has received 510(k) clearance from the FDA and attained CE mark for PreAnalytiX PAXgene Blood RNA System. In addition, PreAnalytiX Quality System received ISO 9001:2000 and EN ISO 13485:2003 certification from the notified body TUV.
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