fbpx Yourgene Health plc - Home
Image is not available
Image is not available
Image is not available
Image is not available
Image is not available
Image is not available
previous arrow
next arrow
Slider

The IONA® test is a CE-marked in vitro diagnostic product which meets the requirements laid out in the European In Vitro Diagnostic Directive (98/79/EC). The IONA® test system meets the stringent regulatory requirement for a non-invasive screening test and has been externally reviewed by a Notified Body. This is substantially more rigorous than a self-certification CE mark, in line with the IONA® test’s classification under Annex II list B of the Directive. In addition, the IONA® Software for analysis has been built to stringent quality standards  and has been developed with BS EN 62304 compliance. The IONA® test received its CE mark in February 2015. This ensures a high-quality robust, reproducible screening test with verification and clinical validation already performed to enable fast implementation with confidence.

ionaboxtestCE0088