New Industries (300832.SZ) issued an announcement. Recently, the company's human immunodeficiency virus antigen and antibody detection reagents...
Zhitong Finance App News, New Industry (300832.SZ) issued an announcement. Recently, the company's human immunodeficiency virus antigen and antibody test kit (chemiluminescence immunoassay) has obtained the IVDRCE highest risk level Class D certification issued by the EU Notified Body - TÜV SÜD.
The new EU In Vitro Diagnostic Medical Devices Regulation (IVDR, EU2017/746) replaces the original EU In Vitro Diagnostic Medical Devices Directive (IVDD, 98/79/EC) to manage in vitro diagnostic medical devices in the EU market. Up to now, the company has obtained IVDR CE certification for a total of 169 chemiluminescence reagent products and 58 biochemical reagent products. According to the provisions of the EU in vitro diagnostic medical device regulations, the products that have obtained the IVDR CE certification already have the necessary conditions to enter the EU market. In the future, the overall competitiveness of the company's products will be further enhanced, which will have a positive impact on the company's future operations.
