ORGENTEC that’s us: The faces behind the products

Fuelled by Innovation: With a pioneering spirit, a nearly inexhaustible supply of ideas, and high technical expertise, ORGENTEC has become firmly established in medical diagnostics. Our employees’ talent and skills establish the basis for our success. At our headquarters in Mainz 130 people are busy in research and development, manufacturing and quality control, packaging and shipping, marketing and sales. Their commitment is the reason why laboratories everywhere rely on the high standards and excellent service provided by ORGENTEC Diagnostika.

New ideas move us forward and guarantee future innovation. Creative scientists, experienced engineers, and highly educated technicians work with great dedication on the development of new products and the continual improvement of our established test systems. New results from medical research are quickly identified and implemented -- often in cooperation with renowned research facilities around the world.

ORGENTEC Diagnostika excels with superior product quality and excellent service. These originate at our in-house production facility at the company headquarters in Germany, where we practice constant, meticulous quality control. We are certain that we only truly control those things we develop and produce under our own management. We also maintain strict control over the logistics chain. Storage, packaging, and shipping are controlled and carried out in Mainz by experienced ORGENTEC employees. We are thus able to maintain our own high standards of quality.

Ideas, corporate courage and steady growth – these form the basis for more than twenty years of success at ORGENTEC Diagnostika. We work for the benefit of patients with cutting-edge research and technological progress.

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 13485 in the latest version. It is also certified to Canadian ISO 13485 under CMDCAS (Canadian Medical Devices Conformity Assessment System).

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.