Shanghai Zhicheng Biotechnology Co., Ltd. is affiliated to Zhongyuan Xiehe Cell Gene Engineering Co., Ltd. (stock code: 600645), located in Shanghai International Medical Park (Medical Valley). Since its inception, it has become a high-tech enterprise with years of experience in R&D, production, and operation of medical diagnostic biological reagents and medical instruments, and is one of the manufacturers with the most complete range of biochemical diagnostic reagents in China. Most of the company's products adopt FDA or EU certified technologies, and some products reference IFCC recommended methodologies. The company has established cooperative relationships with more than 600 hospitals, enterprises, clinical testing centers, central laboratories, universities, and research institutes, and has a broad market base. Shanghai Zhicheng Biotechnology Co., Ltd. has obtained registration certificates for nearly 100 diagnostic reagent products, covering eight series including liver function, blood lipids, kidney function, glucose metabolism, myocardial enzyme spectrum, electrolytes and trace elements, specific proteins, and pancreas and prostate. The scope of products has also expanded from a single biochemical diagnostic reagent to immunodiagnostic reagents and diagnostic instruments. The company currently holds multiple patents and has mastered core technologies including biochemical diagnostic reagents, immunodiagnostic reagents, and diagnostic instrument preparation. The company is the sole first-level agent in China for RANDOX Laboratory Diagnostics Ltd. of the UK, and owns self-owned brands such as DONUO® and Niukefast Diagnostics, as well as two wholly-owned subsidiaries: Shanghai Niuke Biotechnology Co., Ltd. and Shanghai Zhicheng Medical Devices Co., Ltd. The company has established a complete quality management system covering the entire process of R&D, production, processing, and testing, fully reflecting the concept of quality first. The products developed by the company must not only undergo evaluation by the project team, R&D department, and the company's quality department, as well as clinical verification tests at multiple top-tier hospitals, but must also pass strict inspections by the drug regulatory authority and testing by registration testing institutions before being applied in clinical settings. Mastering core technology and creating high-quality products are the development goals. In recent years, the company has invested substantial human and material resources to build core technologies, and it is believed that in the future, Zhicheng will continue to enrich its product portfolio while ensuring quality and service. On this basis, the company has also obtained multiple patent authorizations and Shanghai Biomedical Industrialization Fund. Enterprise honors: 1. The company has been recognized as a "High-Tech Enterprise" by the Shanghai Municipal Science and Technology Commission. 2. The company has established the "Zhicheng" scholarship with the Laboratory Medicine Department of Ruijin Clinical Medical College of Shanghai Jiao Tong University. 3. The company has been rated as a "Shanghai Pudong New Area R&D Institution". 4. The company has been rated as a "Shanghai Science and Technology Little Giant Cultivation Enterprise". 5. The company has become a member of IFCC (International Federation of Clinical Chemistry and Laboratory Medicine). 6. The company has been rated as a "Shanghai Integrity Creation Enterprise". 7. The company has obtained the ISO13485 certificate issued by TUV Germany.
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