Core Viewpoint - The company has received the highest risk level Class D certification for its hepatitis B virus core antibody test kit from TÜV SÜD, a European Union notified body, under the new IVDR regulations [1] Group 1: Certification and Regulatory Compliance - The hepatitis B virus core antibody test kit utilizes magnetic microparticle chemiluminescence method [1] - The new EU In Vitro Diagnostic Medical Devices Regulation (IVDR, EU 2017/746) replaces the previous In Vitro Diagnostic Medical Devices Directive (IVDD, 98/79/EC) for managing in vitro diagnostic medical devices in the EU market [1] - The company has achieved a total of 212 chemical luminescence reagent products and 67 biochemical reagent products certified under IVDR CE [1]
新产业(300832.SZ):产品获得IVDR CE认证