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Quality Management Systems

The high reputation of Reagena as a trusted, proven supplier of reagents, test kits and chemistry solutions is based on our long commitment to high quality standards, and on a comprehensive understanding of customer needs.

Certified ISO 9001:2015 and  ISO 13485:2016 Quality Management Systems cover all of our activities, and provide a solid basis for continuous development of quality products and services.

Reagena produces a broad spectrum of optimised diagnostic products and reagents.

Our IVD products are CE-marked (IVDD 98/79/EC).

Products for pharmaceutical industry comply with current European Pharmacopoeia standards (Ph. Eur.

Quality certificates