Certified Quality – Foundation of our Success
Since 1986, Immundiagnostik develops and produces laboratory diagnostics at the highest level.
As manufacturer of in-vitro-diagnostics, we comply with the German Medical Product Law (MPG) and the IVD-guidelines 98/79/EG. Our quality management is certified according to ISO EN DIN 9001 und ISO EN DIN 13485. A good portion of our products is marketed with the CE-sign after being thoroughly validated in clinical and scientific settings as part of our academic and industrial collaborations.
Alongside the constant inhouse quality management we participate on a regular basis in independent external quality controls, e.g. interlaboratory studies (INSTAND e.V., KEQAS). Moreover, our customers always achieve best results with our products in independent quality controls.
This exceptional quality creates trust and is the foundation of Immundiagnostiks’ success for more than 20 years.


