News

AJ Roboscreen Obtained CE Mark and lot Approval Documents for the RoboGene® HCV RNA Quantification Kit

Jena/Leipzig, July 31, 2012 — AJ Roboscreen, an Analytik Jena company, recently obtained the EC certificates stating that the Quality System and Design Examination concerning the RoboGene^® HCV RNA Quantification Kit showing are conform to the European IvD regulations.

Therefore it is proven that both the quality system and the design examination of the kit which is based on the company-owned TripleHyb^® chemistry for real-time fluorescence PCR meet all the requirements according to Annex IV — Sections 3 and 4, respectively, of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Further CE labelled kits will follow soon.