Mediagnost Gesellschaft für Forschung und Herstellung von Diagnostika GmbH

Development, manufacture and distribution of in vitro diagnostic medical devices (immunochemistry and infectious immunology) and their raw materials

Mediagnost Gesellschaft für Forschung und Herstellung von Diagnostika GmbH was founded in 1985 in Tübingen and quickly developed into a modern and innovative biotechnology company. Today, Mediagnost is a globally active manufacturer of diagnostics. In the Technologiepark Tübingen-Reutlingen, Mediagnost has the most modern and well-equipped facilities for research and production under optimal conditions. The laboratories are approved for S2 work. The company's key qualifications lie in the research and development of serological test methods in the indication areas of infectiology and endocrinology.
The production of the diagnostics is subject to the quality requirements for medical products according to the German law on medical products and the European Directive 98/79/EG. Accordingly, Mediagnost has a quality management system that is certified according to ISO 13485:2016 by a notified body. Working on research projects for the development of diagnostics with higher efficiency and sensitivity using the latest technologies and the development of new fields of application for existing test systems is an important task for Mediagnost in order to offer customers optimal solutions. One of Mediagnost’s core competencies is the implementation of an experimental laboratory test in a marketable test kit that meets the regulatory requirements of the In vitro Diagnostics. Thanks to its proximity to the University of Tübingen and contacts to other research institutions, Mediagnost is able to convert scientific findings into marketable products. Other core competencies in the field of infectiology lie in the production of viral antigens (e.g. Hepatitis A Virus Antigen) and bacterial antigens (e.g. Pseudomonas aeruginosa antigens), as well as in the extraction and manufacture of monoclonal antibodies, which are used as raw materials by global players in the diagnostics industry.

Category Biotechnology
Working areas Biotechnology, Diagnostics, Services, Development, Medical products
Year of foundation
1985
Employees
25

News

12.05.2020

Mediagnost Anti-SARS-CoV-2 ELISA is CE marked

Mediagnost has developed a test procedure that can detect antibodies against the new SARS-CoV-2 in human blood. The Anti-SARS-CoV-2 ELISA has been CE marked since May 6, 2020.