Quality Management System

Focused on your Success

DIARECT is one of the leading suppliers of antigens for autoimmune diagnostics and infectious serology. Providing customers with products and services of constantly high quality is its philosophy. We are well aware that key components have an immense impact on the development and success of immunodiagnostic test systems. DIARECT's goal is to provide quality products and services which meet its customers' current and future expectations.

Therefore, all products are developed, produced and distributed according to a Quality Management System that is certified for compliance with ISO 9001 and 13485 standards. In addition, since 2002, DIARECT has been listed as a manufacturer of human recombinant antigens for autoimmune testing in the database of the U.S. Food and Drug Administration (FDA). Follow this link to view DIARECT's FDA registration data (search Registration Database using DIARECT as Establishment Name).

ISO 9001 Certificate

ISO 13485 Certificate

Production facilities of SurModics IVD, manufacturer of protein stabilizers / blockers and BioFX® substrates and accessory reagents, operate in an environment in accordance to the ISO 9001 and ISO 13485 standards as well.