MOUNTAIN VIEW, Calif., Dec. 14, 2015 /PRNewswire/ -- Clontech Laboratories, Inc., a wholly-owned subsidiary of Takara Bio Inc. and provider of innovative reagents and kits for the life sciences, announced today that it has earned ISO 13485:2003 certification, an internationally-recognized quality standard for medical devices and related services.
This certification confirms that Clontech has successfully implemented a quality management system that conforms to the world-wide standard for medical device and diagnostic manufacturing.
"This achievement demonstrates Clontech's continuing commitment to understanding and meeting the quality needs of all our customers. As a core value, we strive to provide our customers with high quality, innovative products and services. This certification recognizes our commitment to maintain and build on these high standards to ensure delivery of superior products and provide a quality foundation to our customers for their use in the development of diagnostic products," said Loretta Momme, Director, Operations at Clontech. "Obtaining ISO 13485:2003 certification is a critical step in our efforts to deliver the highest quality PCR enzymes and other reagents for clinical research and molecular diagnostics applications, including General Purpose Reagents, GMP-grade reagents, and OEM and custom solutions."
ISO (International Organization for Standardization) is an independent, non-governmental membership organization and the world's largest developer of voluntary International Standards. ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Clontech Laboratories, Inc., a wholly-owned subsidiary of Takara Bio Inc., develops, manufactures, and distributes a wide range of life science kits and reagents under the Takara®, Clontech®, and Cellartis® brands. Key products include SMARTer® cDNA synthesis kits for a variety of samples and applications, including NGS; high-performance qPCR and PCR reagents (including the TaKaRa Ex Taq®, TaKaRa LA Taq®, Titanium®, and Advantage® enzymes); Cellartis stem cells and stem cell reagents; RT enzymes and SMART® library construction kits; the innovative In-Fusion® cloning system; Guide-it™ gene editing tools; Tet-based inducible gene expression systems; Living Colors® fluorescent proteins; and a range of Macherey-Nagel nucleic acid purification tools. These and other products support applications including NGS; gene discovery, regulation, and function studies; protein expression and purification; RNAi, gene editing, and stem cell studies; and plant and food research. For more information, visit www.clontech.com.
About Takara Bio Inc.
Takara Bio Inc. is an innovative biotechnology company based in Shiga, Japan. As a world leader in biotechnology research and development, Takara Bio was the first company to market PCR technology in Japan and is also the developer of the RetroNectin® reagent, which is used as a world standard in gene therapy protocols. In addition to providing research reagents and equipment to the life science research market, Takara Bio has active research and product development activities in the fields of gene and cell-based therapy and agricultural biotechnology; and is committed to preventing disease and improving the quality of life for all people through the use of biotechnology. Through strategic alliances with other industry leaders, Takara Bio aims to extend its reach around the world. More information is available at www.takara-bio.com.