Pleasanton – October 16, 2026 -- n6 Tec, Inc. has received ISO 13485:2016 certification from Intertek for its quality management system, covering the manufacture and service of genetic research instrumentation at its Pleasanton, California headquarters.
Certificate 0259003 runs through October 2029
Intertek issued the initial certificate on October 12, 2026. It is valid through October 11, 2029, subject to ongoing surveillance by the certification body.
ISO 13485:2016 is the international quality management standard for organizations that design, manufacture and service medical devices. An independent auditor must verify that documented processes for design controls, supplier management, manufacturing, traceability, corrective and preventive action, and customer feedback exist and are followed.
Certification covers the icon16 and icon96 platforms
n6 says the controlled processes support repeatable performance of its iconPCR-based instruments, including the icon16 and the high-throughput icon96, and their AutoNorm adaptive amplification workflows. AutoNorm combines real-time amplification, quantification and normalization in one automated step to produce sequencing-ready NGS libraries. Supported sample types include FFPE tissue, cfDNA and microbiome samples.
The company is targeting genomics cores, biopharma teams and translational research groups that audit their suppliers. It also describes the certified system as a building block for organizations planning to serve more regulated markets.
Instruments remain research-use-only across 25+ countries
n6 products are for research use only and not for use in diagnostic procedures. Customers and distribution partners use the instruments in more than 25 countries.
CEO Pranav Patel said the certification is independent confirmation that "quality is built into every step at n6," and that it gives customers and distribution partners confidence in the instruments they rely on today.