普门科技:26项电化学发光试剂产品及血红蛋白层析柱获IVDR CE认证

Core Viewpoint - The company has received IVDR CE certification for 26 electrochemical luminescence reagent products and hemoglobin chromatography columns, enhancing its competitiveness in the EU market and other regions recognizing IVDR CE certification [1] Product Certification - The certified products include hs-cTnI (eCLIA), Heart-type Fatty Acid Binding Protein (Electrochemiluminescence immunoassay), and Lipoprotein-Associated Phospholipase A2 (Electrochemiluminescence Immunoassay) [1] - Additionally, the certification covers Multi Control Cardiac Marker composite quality control products [1] Certification Validity - The certification for these products is valid until June 23, 2029, indicating a long-term approval for market access [1]