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.
In EU, four types of NanoZoomer (NanoZoomer-SQ, NanoZoomer S210, NanoZoomer S60, NanoZoomer S360), NDP.view2 (U12388-21), NDP.view2 Plus (U12388-22) and NDP.serve3 software are CE marked under EU’s In Vitro Diagnostics Directive (IVDD) for in vitro diagnostic use. In China, five types of NanoZoomer (NanoZoomer 2.0-HT, NanoZoomer2.0-RS, NanoZoomer -SQ, NanoZoomer S210, NanoZoomer S60) are registered for in vitro diagnostic use.
In the US, Japan and other countries, NanoZoomer is for research use only and is not permitted to use for clinical diagnostic purposes.