SERION Diagnostics

Your Partner in Infectious Serology

Core of the SERION Diagnostic business is the development, manufacturing and distribution of SERION ELISA classic tests.

Starting as a distribution company for CFT reagents, we are now able to offer one of the largest ELISA portfolios for the diagnosis of infectious diseases worldwide, ranging from the most common to the rarest of communicable diseases.

With the range of test systems available (SERION ELISA classic, SERION ELISA antigen, SERION CFT) along with automation solutions and dedicated software tools we offer ease of handling combined with highest quality. Discover our comprehensive product portfolio right now!

 

Everything under one roof

Having research and development, production, antigen production and quality control under one roof is the key for providing you consistently high quality in vitro diagnostic products.

The optimal test setting is defined by a team of specialists in the R&D department. The central component of our IVD tests - the antigens – are manufactured for most of our assays in our own antigen production department. Here, more than 100 different antigens both native and recombinant, are produced. About 50 of them are incorporated into our immunoassays. Based on this extensive expertise in manufacturing of high quality antigens, raw materials to the diagnostic industry are supplied via the SERION Immunologics division. The automated coating process in the manufacturing department guarantees highly reproducible conditions. State-of-the-art in-process controls and the batch releases are performed in the quality control department and are in accordance with our quality standards to ensure a high degree of product safety for end-users. And last but not least with approximately 180 m3 cooled storage space and 10.000 to 15.000 products on stock prompt delivery is ensured.

All in vitro medical devices manufactured by SERION Diagnostics are in full compliance with current national and international requirements. Certified to EN ISO 13485:2012 the company ensures conformity to the European Directive 98/79/EC, the German Medical Products Law as well as the requirements of regulatory authorities worldwide.

While in Germany customers are served by our sales team of product specialists, internationally a global network of more than 80 distributors from different countries and offices in Brazil and China are selling our products all over the world. Fast and reliable support is guaranteed by our customer and technical support team.

All this makes SERION Diagnostics a competent and trustful partner in the field of diagnosis of infectious diseases. It is our mission to meet and exceed your expectations! Worldwide