Another Chinese-made new crown nucleic acid testing kit has been approved for emergency use in the United States

after obtaining CE certification from the European Union, Pansheng's new crown kit has been certified by the U.S. EUA.
June 6, Beijing Pansheng Gene Technology Co., Ltd. (the "Panshengzi") announced that its self-developed new coronavirus nucleic acid testing kit, Genetron SARS-CoV-2 RNA Test, was issued by the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).
addition, Pansheng's new crown inspection kit was also selected in the China Medical and Health Products Import and Export Chamber of Commerce's list of new crown inspection reagent manufacturers (the medical insurance chamber whitelist), allowed to export overseas. Previously, the kit has completed a full set of EU CE certification, access to the European market.
, Pansheng announced that it had completed the development of a new coronavirus nucleic acid testing kit and entered the emergency approval channel process of the State Drug Administration (NMPA). According to Pansheng, the kit has the advantages of comprehensive precision, simplicity, speed and pollution prevention, and is suitable for the rapid detection of large-scale samples, and efficiently enhances the detection capability of the new coronavirus.
pan-births also said it had provided new crown kits for some of the world's most affected areas to help them rapidly conduct large-scale virus testing.
The State Drug Administration's query data show that as of June 6, there are currently 39 new crown virus testing reagent products approved in China, including 1 protein testing kit, 19 anti-medical test kits, 19 nucleic acid testing kits.
according to public reports and the China Medical and Health Products Import and Export Chamber of Commerce on June 5, "to obtain foreign standard certification or registration of medical materials production enterprises list" incomplete statistics, since the end of March, the domestic Huada Gene, Fosun Pharma, Nanjing Covis, Minder Bio, Mike Bio, Oriental Gene, Antu Bio, New Wave Biology, Selex Biology, Diko Bio and other 10 enterprises of the new crown nucleic acid reagents have been certified by the United States FDA.
EUA, or Emergency-Use-Administration, emergency use rights, in early February, the United States in response to the shortage of various types of medical devices issued a variety of EUA, this is a temporary "pass" to market, but also the fastest way to enter the U.S. market. It is important to note that EUA-qualified products are no longer available for re-listing after the FDA declares the outbreak over, and routine registration applications are required.