In vitro diagnostic (IVD) device is the term used for materials (for example, reagents, instruments, and software) used to perform laboratory tests. IntelligentMDx designs, and plans to commercialize IVD tests under a rigorous Quality System that is compliant with FDA Quality Systems Regulations and guidances, ISO 13485:2003 and that are compliant with the European In Vitro Diagnostics Directive (IVDD: Directive 98-79-EC). It is IntelligentMDx’s intent to see that all of our products are cleared by the appropriate regulatory bodies.