SDIX, LLC, an OriGene Company, Achieves Significant Milestone with ISO 13485:2003 Certification

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SDIX Achieves ISO 13485:2003 Certification

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SDIX, LLC, an OriGene Company

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.

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 http://www.sdix.com/Products/IHC-Antibodies.aspx

About OriGene Technologies:
OriGene Technologies, Inc. is a gene centric life sciences company dedicated to support academic, pharmaceutical and biotech companies in their research of gene functions and drug discovery. OriGene's novel product line includes the world's largest cDNA and shRNA clone collections, over 12,000 purified human proteins produced from mammalian (HEK293) cells, over 50,000 high quality primary antibodies including TrueMAB ™ mouse monoclonal antibodies and polyclonal antibodies made against full-length proteins for the conservation of native epitopes, validated “mono-specific” monoclonal antibodies called UltraMAB® which offer a unique solution to the critical issue of antibody specificity, >140,000 highly validated human tissues, and protein microarray products and services. For more information, visit http://www.origene.com.

About SDIX, LLC
SDIX, LLC is a wholly owned subsidiary of OriGene Technologies, Inc., specializing in the design, development and manufacture of high quality antibodies for the diagnostic, pharmaceutical and biotechnology markets, including the best in class troponin antibodies. For over 20 years, SDIX has been manufacturing antibodies that enable customers to meet high performance and commercialization objectives.

For more information, visit http://www.sdix.com

For inquiries please contact:
Mark Watson
Vice President, Business Development
OriGene Technologies, Inc.
Tel: 301-340-3188 ext. 235
E-mail: businesssdev(at)origene(dot)com

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Mark Watson
OriGene Technologies
301-340-3188 Ext: 235
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