Shengxiang Biotech (688289.SH) products obtained medical device registration certificate and EU CE certification

Zhitong Finance App News, Shengxiang Biotech (688289.SH) issued an announcement. The company recently obtained three product certifications and registrations, two of which are national Class III medical device registration certificates and one is EU CEIVDR certification.

Norovirus, rotavirus, and enterovirus are all common pathogens that cause viral diarrhea. They are highly infectious and widely distributed, and are particularly susceptible to infection among children and the elderly. The company's launch of two new products, a single norovirus test and a group A rotavirus/norovirus/group F enteric adenovirus triple test, will greatly enhance clinical capabilities for rapid identification and accurate diagnosis of diarrhea pathogens, and build a solid line of defense for the intestinal health of key population groups such as children and the elderly in China.

EB virus infection is very common among people. It is not only the culprit of infectious mononucleosis, but is also closely related to the occurrence and development of lymphoproliferative disease (PTLD) after organ transplantation and various tumors such as nasopharyngeal cancer, Hodgkin's lymphoma, and gastric cancer. The EB virus detection reagent has obtained EU CEIVDR certification, further enriching the company's herpes virus testing product line. It also marks that the company fully complies with strict international standards in terms of product quality, technical performance and management system, which is one of the important achievements of the company's molecular diagnosis strategy and internationalization strategy.