SAN DIEGO, CA – June 20, 2004 - Diazyme Laboratories, a company that applies its proprietary Substrate Trapping-Enzyme Technology®(STE) platform to develop low cost and high quality diagnostic products for clinical and research uses, announced today that it has received ISO 13485:2003 certification from TUV Rheinland of North America, Inc.
The ISO 13485:2003 standards, released in July 2003 as the successor to ISO 13485:1996, is an internationally recognized quality management system standard developed by the International Organization for Standardization (ISO). To be certified to the standard, companies need to demonstrate their ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. This includes the implementation a quality management system (QMS) addressing staff training, design and development of products, certification and purchasing of materials and services, and product labeling and delivery.
Diazyme Laboratories is a Division of General Atomics headquartered in La Jolla, California. Diazyme Laboratories, through its STE Technology, focuses on the areas of small molecule (metabolites and drugs) detection, single nucleotide polymorphism (SNP) identification, and recombinant enzyme based diagnostic reagents. STE Technology® is also used to develop protein pharmaceuticals, especially receptor antagonists for treatment of immune related diseases and cancers.
TUV Rheinland of North America, Inc., headquartered in Newtown, Conn., USA, is a subsidiary of TÃœV Rheinland Group, Germany, and is a global leader in compliance engineering, testing and quality registration services for domestic and foreign markets. Diazyme Laboratories chose TUV Rheinland of North America, Inc. as their registrar and was officially certified on June 17, 2004. Diazyme currently sells their standing products throughout the world, both by selling direct and through various domestic and international distributors.
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Posted on Jun 20, 2004