Shenzhen Ultra-Diagnostics Biotec. Co., Ltd. (hereinafter referred to as UD-Bio) was founded in June 2016 and is headquartered in Shenzhen. It is a Shenzhen and National high-tech company engaged in the research, development, production, sales and services of IVD instruments and reagents. UD-Bio dedicates in the comprehensive product line of Thrombus & Hemostasis, Inflammation detection, POCT rapid diagnosis. UD-Bio processes a total production and office area of more than 5,000 sqm, of which more than 1000 sqm are GMP workshop, and more than 30 products have obtained China NMPA certification and EU CE certification. Since the product launch in 2018, UD-Bio’s thrombus and hemostasis products have been stationed in over 200 secondary and tertiary hospitals in China. In the international market, UD-Bio’s products have been sold to dozens of countries in Europe, South Asia, Middle East, Africa, Latin America and other regions.

After the novel coronavirus outbreak in 2020, with our keen insight and deep technical accumulation in the field of POCT, UD-Bio rapidly developed the SARS-CoV-2 IgM & IgG antibody combined rapid test kit (Colloidal gold), SARS-CoV-2 antigen rapid test kit ( Colloidal gold), multipoint SARS-CoV-2 nucleic acid test kit, and SARS-CoV-2/Influenza A+B antigen combo rapid test kit, and most of them had obtained CE certification and entered the white list of CCCMHPIE. The product quality has been recognized and sold in many countries around the world. The current daily production capacity can reach 500,000-1 million tests.

UD-Bio possesses a perfect technology development and quality management system, has more than 90 employees in total and 40% of them are engaged in R&D. At the same time, UD-Bio has established a complete intellectual property management system and passed the intellectual property management system certification. UD-Bio always adheres to the quality policy of "excellent quality, perfect service, continuous improvement, and continuous innovation", with high standard quality management requirements, and has passed the TUV ISO13485 certification.

UD-Bio will continue to provide cost-effective products and services to customers around the world, and achieve high-quality life with excellent products!