Search
On February 17, Durastab Medtech Ltd. formally obtained ISO 9001:2015 quality management system certification. This internationally recognized accreditation signifies the company's advancement to a new level of standardization and normalization in the research, development, production, and quality management of in vitro diagnostic (IVD) raw materials and reagents. It lays a solid foundation for delivering higher-quality industrial-grade products to global customers.
As a biotechnology enterprise co-founded by Chinese and international technical experts, Durastab remains dedicated to innovation in biological detection technologies, focusing on the development and industrialization of IVD raw materials and supporting solutions. The company has established a diversified R&D platform covering chemiluminescence, ELISA, Western Blot, lateral flow, and biochip technologies. It has successfully launched over 30 categories and 100 types of ready-to-use reagent products, including core materials such as chromogenic/luminescent substrates, protein/enzyme stabilizers, and blocking agents. These products are widely applied in in vitro diagnostics, biopharmaceuticals, and scientific research.
Quality-Centric Approach: Building a Comprehensive Management System
Behind the ISO9001 certification lies Durastab's relentless pursuit of product quality. The company is equipped with fully automated chemiluminescence analyzers, multi-functional enzyme-linked immunosorbent assay (ELISA) readers, UV-visible spectrophotometers, fluorometric immunoassay analyzers, micro-volume liquid dispensing and detection equipment, and GMP-grade purified water systems. It maintains standard Class 10,000 and Class 100,000 cleanrooms to ensure strict control over production environments and processes.
From raw material selection to finished product delivery, Durastab guarantees high product stability and batch-to-batch consistency through its comprehensive quality monitoring system and stringent supply chain management. With a maximum batch production capacity of 1,950 liters, it fully meets the large-scale demands of global IVD companies, biopharmaceutical clients, and research institutions.
Join Us at CACLP 2025 to Shape the Industry's Future
Durastab will showcase its full product portfolio at the 22nd China International Exhibition on Laboratory Medicine and Transfusion Instruments & Reagents (CACLP) from March 22-24, 2025, at the Hangzhou International Convention and Exhibition Center. As Asia's largest and most influential IVD industry event, this edition is expected to attract over 1,500 exhibitors. Durastab will showcase its full product portfolio, collaborating with industry partners to explore technological trends. On-site customized solution services will also be available to accelerate clients' product development cycles.
About Durastab:
Durastab Medtec LTD has always adhered to the mission of "making diagnostic reagents more stable and more accurate" since its establishment, and is committed to providing excellent ready-to-use reagent solutions to global advanced medical diagnostic companies.
Until now, Durastab has provided products or services to more than 600 companies and 500 scientific research institutes, of which more than 50 IVD companies are listed companies in China or overseas.
