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Biotime has always adhered to the concept of "Quality is the vitality of the enterprise", and has built a 100,000-level clean production workshop of more than 2,000 square meters, strictly in accordance with the national medical device production standards and GMP specifications, and controls all aspects of the product from research and development to production. And strive to deliver the best and most stable products to customers!
At present, we have successfully developed FDA EUA, ISO 13485, NGSP, 64 NMPA approved and 35 CE approved POCT kits/instruments for the analysis of cardiac, hormone, diabetes, infection, kidney disease, tumor markers, etc, we also have 18 patents have been authorized, of which 9 products including diagnostic kits for TSH, progesterone and HCG quantitative assays based on the fluorescent lateral flow immunoassay platform are the first innovations in China.
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