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HTG Achieves ISO 13485:2003 Certification

NEW YORK (GenomeWeb News) – HTG Molecular Diagnostics said today it has received ISO 13485:2003 certification for the design, manufacture, and distribution of instruments, software, reagents, and test kits for gene expression analysis.

The certification covers the design, development, production, and sale of the HTG's qNPA technology-based products and services. According to the company's website, the gene expression technology combines a lysis-only, no amplification protocol and multiplexing of up to 47 genes per well for the multi-parameter evaluation of any sample type.

In order to get certified, the Tucson, Ariz.-based firm had to demonstrate it has quality management systems to meet customer and regulatory requirements for the design and development of medical devices, it said.