Zhitong Finance App News, Oriental Biotech (688298.SH) announced that the company and its wholly-owned subsidiary US Hengjian Biotechnology Co., Ltd. (“American Hengjian”) (collectively, the “Company”) have recently obtained the US Food and Drug Administration FDA 510 (K) license for fentanyl urine test reagents (professional/self-test) and the EU IVDR for drug testing analyzers.

This time, the US Hengjian fentanyl testing series products have obtained US FDA 510 (K) certification and can be used to qualitatively test whether urine contains fentanyl. The test product is easy to operate, produces quick results, and is suitable for testing by professional institutions or home self-tests. It has enriched the types and application fields of drug testing products that the company can sell in the US market to meet market testing needs and facilitate the expansion of the US market. This time, the drug testing analyzer obtained the EU IVDR, which can be used by the company with drug detection reagents certified in the EU to qualitatively test whether there is potential drug abuse in human samples. This product is suitable for operation by professional institutions, which is conducive to the expansion of the company's related testing business in the European market.