Europe: For in vitro diagnostic use. The chemagic 360-D instrument meets the requirements of the In Vitro Diagnostic Medical Device Directive (98/79/EC). The CE IVD-registered chemagic 360-D instrument is for distribution and use in specific European countries only. USA: For in vitro diagnostic use. The chemagic 360-D instrument is FDA listed and if used in combination with chemagic kits indicated for use with the chemagic 360-D instrument, is intended for applications described in the respective kit insert.