Nanomix Corporation announced that it has received the EU Quality Management System Certificate under the new In Vitro Diagnostic Medical Devices Regulation (IVDR) for its eLab analyzer, part of the Nanomix eLab® system. The European Union (EU) IVDR replaces the legacy In Vitro Diagnostic Directive (IVDD) and was created to ensure a greater level of patient protection and regulation around the creation of in vitro diagnostic devices (IVDs). The Nanomix eLab® system is a rapid, easy-to-use, quantitative detection platform that performs a range of in vitro diagnostic assays.

The platform consists of a hand-held analyzer and a disposable cartridge. The eLab System utilizes a proprietary nano-biosensor with multiple detection electrodes to generate multiple electrochemical assay results from a single patient sample. The Nanomix eLab® system offers a variety of benefits, including results in minutes, lower cost, and portability, while providing accurate, quantitative results comparable in quality to those provided by central lab testing.

The Nanomix eLab® system has received the CE marking in Europe.