ORGENTEC Diagnostika GmbH
ORGENTEC Diagnostika | Your Partner in Laboratory Diagnostics
Since its inception in 1988, Mainz-based ORGENTEC Diagnostika has been a world market leader in the development, production, and marketing of test systems for laboratory autoimmune diagnostics. ORGENTEC as an expert manufacturer has developed more than 200 highly specific ELISA test systems, as well as blot and immunofluorescence tests for diagnosing autoimmune diseases (autoimmune disease diagnostics) and infection serology (infectious disease diagnostics). Many of these are protected by patent rights.
Comprehensive Product Portfolio
We offer test systems for diagnostics and treatment-associated monitoring in the following clinical areas:
diagnosis of inflammatory rheumatic diseases – this is clearly the main focus of our research and development efforts
thrombosis diagnostics – we now offer more than 30 different test systems in this area
ANCA diagnosticsfor the serological detection of autoimmune vasculitides
thyroid diagnostics, gastroenterology, diabetes diagnostics, etc.
ELISA testsystems for fully automated infectious disease diagnostics – infection serology
Consistency in Quality and Service
Our in vitro diagnostic medical devices (IVD) are CE marked according to the European IVD Directive 98/79/EC.Our quality management system is certified according to ISO 9001 and ISO 13485 in the latest versions. It is also certified to Canadian ISO 13485 under CMDCAS (Canadian Medical Devices Conformity Assessment System).
Certificate EN ISO 9001
Certificate ISO 13485 / CMDCAS
We regularly participate in national and international round-robin tests with our test systems. Institutions such as INSTAND (Germany), UK NEQUAS (Great Britain), RCPA (Australia), and ÖQUASTA (Austria) thus consistently confirm the high efficiency and consistency of our autoimmune tests.
We use the most up-to-date manufacturing technology. Modern and lean production and communications processes, uncompromising customer orientation and rapid implementation of the latest scientific results guarantee our customers and users consistently high product quality as well as absolutely reliable delivery and adherence to schedules. Short decision-making chains and close collaboration with our clients and with scientists all over the world make it possible for us to react rapidly and efficiently to changes in the diagnostics market.
Our fully automatic analytical instrument, the Alegria®, represents a unique single solution for autoimmune diagnostics and infection serology. The fact that our well-established manual tests can be used on the Alegria®, and our special SMC® technology greatly simplify laboratory diagnostics and allow for targeted and patient-specific diagnostics. Since its introduction, the Alegria® has won awards both nationally and internationally, including the Medical Design Excellence Award.
Laboratories in more than 100 countries rely on the high standard and quality of our products and on our outstanding service. In Germany, Austria, Hungary, France and Switzerland, we provide direct service to our customers with our own personnel or branch offices; in other countries and regions we market our products through an established network of distributors.