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DiaCarta Receives ISO 13485:2003 Certification

by | Sep 26, 2016 | Press Releases

DiaCarta, an innovator in precision molecular diagnostics, today announced that the company has received ISO 13485:2003 certification for the design, manufacture and distribution of its diagnostic and molecular genetic testing kits.

The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of quality management systems. The ISO 13485:2003 Quality Management Standard for Medical Devices represents the requirements for a comprehensive management system for the design and manufacture of medical devices.

“ISO 13485:2003 certification is a landmark achievement for DiaCarta and demonstrates our commitment to design and manufacture high quality, robust in vitro diagnostic products to meet and exceed customer expectations,” said Cynthia Virata, Director of QA and Operations for DiaCarta.

“Our ISO 13485:2003 certification demonstrates to the international community that our products are designed and manufactured with the highest level of traceability and quality control,” said Aiguo Zhang, Ph.D., CEO of DiaCarta. “With an expanding global customer base, this level of rigor is giving us the confidence that our products yield accurate, reliable and reproducible results.”

About DiaCarta, Inc.

Headquartered in Richmond, California with an ISO 13485-certified facility, DiaCarta develops, manufactures and markets cancer research and IVD products for precision molecular diagnostics. We specialize in genomic testing for biomarkers and offer clinical sample testing services in our CLIA-certified lab. We have also established our business operations and clinical service lab in Shanghai and Nanjing, China, respectively. QClamp® and OptiSeq are xeno nucleic acid (XNA) based technologies that enable highly sensitive detection of actionable mutations using qPCR and next-generation sequencing (NGS) platforms, respectively, for liquid biopsy and other traditionally challenging specimens. Other XNA applications include CRISPR/Cas9 gene-editing event screening and adapter dimer removal for NGS library preparation. To learn more, visit https://www.diacarta.com.

Lead Source

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