NEW YORK (GenomeWeb) – German autoimmune diagnostics firm Protagen today said that it has received ISO 13485 certification and it now complies with the internationally recognized quality standard for medical devices.
The certification covers the development, production, and distribution of in vitro diagnostics for autoimmune diseases and indicates that Protagen has implemented a quality management system that conforms to the standard for medical device and diagnostic manufacturing.
The company had previously obtained ISO 9001 certification. Based in Dortmund, Germany, Protagen develops diagnostic and companion diagnostic tests. Its proprietary SeroTag biomarker platform uses Luminex xMAP technology to identify disease-specific autoantibodies in a highly multiplexed fashion.