Legal Note

Metafer 4.3 is classified as an in vitro diagnostic (IVD) medical device within the European Union in accordance with the In Vitro Diagnostics Regulation (EU) 2017/746. It carries the CE label unless otherwise indicated and must be used within the scope of its intended purpose. Metafer is utilized in numerous countries worldwide. However, its use for clinical diagnostics depends on the regulatory requirements of each respective country or region. Please note that the hardware components depicted are not part of the Metafer IVD product and are supplied by third-party manufacturers.

Ikaros 6.3 is classified as an in vitro diagnostic (IVD) medi­cal device in the European Union in accordance with the In Vitro Diagnostic Medical Device Directive 98/79/EC. It carries the CE label unless otherwise indicated and must be used within the scope of its intended purpose. Ikaros is utilized in numerous countries worldwide. However, its use for clinical diagnostics depends on the regulatory requirements of each respective country or region. Some hardware components supplied by third-party manufacturers are not includ­ed in the Ikaros IVD product and are therefore not part of the IVD medical device.

Please contact us for further information.