Dynamyx is CE-marked per Annex III of Directive 98/79/EC on in vitro diagnostic medical devices.
In the USA, Dynamyx is for research use only (RUO) and not for use in diagnostic procedures.
OptraSCAN® is an ISO13485 certified company. OptraSCAN® whole slide scanners are CE marked for IVD use. OptraSCAN Systems are for research use only in North America