Declarations of conformity

DiaSys GmbH was one of the first manufacturers declaring in 2000 conformity with directive 98/79/EC for In-Vitro-Diagnostics.

The declaration of conformity for reagents covers all reagents running on analyzers from third-party manufacturers as listed in the DiaSys product catalogue.

For all DiaSys analyzers of the respons® series as well as for Stardust FC/MC, SensoStar and InnovaStar® separate CE-declarations cover the respective parameters available.

For reagents for specific systems marketed by us as cooperation partner of a manufacturer (eg JCA BioMajesty® 6010/C), you will find in addition to the CE declaration of the manufacturer a separate declaration of conformity with approved parameters.

Updated declarations of conformity will be available immediately on this page.

Downloads of declarations of conformity

List of applied standards

JCA-BioMajesty® 6010/C Analyzer 
respons®A1c analyzer
respons®A1c test kit
SensoStar GL30 touch
SensoStar GLH six