Guangzhou Wondfo Biotech Co.,Ltd (China)

Guangzhou Wondfo Biotech Co., Ltd is a company located in Guangzhou, China. The company specializes in the research, production, and sales of rapid diagnostic products in the field of biopharmaceutical in vitro diagnostics, including reagents and instruments. It is the first domestic in vitro diagnostic reagent enterprise to pass the on-site assessment of "zero defects" by the US Food and Drug Administration. The company has been recognized as a "national high-tech enterprise," "demonstration base for the industrialization of biotechnology high-tech by the National Development and Reform Commission," and a "key enterprise in the export of electromechanical and high-tech products" by the Ministry of Commerce. It has obtained international authoritative quality management system certifications such as CE, ISO9001, and ISO13485. The company has established a production line for colloidal gold rapid diagnostic reagents with international advanced level, covering an area of 2000 square meters of clean production workshops, with an annual production capacity of 160 million people. In 2011, the National Development and Reform Commission approved the establishment of the "National Local Joint Self-Inspection Rapid Diagnostic Engineering Laboratory" in the company. The company's research and development products cover more than 70 varieties in 8 major series, including infectious diseases, pregnancy, cardiovascular diseases, drug testing, tumors, autoimmune diseases, food safety testing, and integrated instrument reagents. The company's sales volume has been increasing year by year, making it one of the leading medical device manufacturers in China and a leader in the POCT industry.