Newark, DE – April 7, 2015 SDIX, LLC, a leading immuno-solution company, specializing in the design, development and manufacture of high quality antibodies for the diagnostic, pharmaceutical and biotechnology industries, today announced it has received ISO 13485:2003 certification. ISO 13485:2003 is the established quality standard for manufacturers of finished medical devices and/or critical components within a medical device platform.
“We believe that successful attainment of ISO 13485:2003 certification for OriGene and SDIX is a critical step and an important achievement as OriGene seeks to commercialize a new class of in vitro diagnostic (IVD) products such as our CE marked UltraMAB® Antibodies. Surpassing this milestone through the implementation of a world-class quality management system that complies with the requirements of ISO further illustrates our global commitment to serve the diagnostic and research antibody markets through the development of the highest quality “mono-specific” antibodies available within the market today. Production of UltraMAB® under ISO standards enables OriGene to further meet the demands of a growing IVD market, where high quality and specificity are paramount” said Wei-Wu He, Ph.D., OriGene’s Chairman and Chief Executive Officer.
For additional information about of the CE Marked UltraMAB® product portfolio please visit IHC-Antibodies.