Beijing Leadman Biochemistry Secures IVDR CE Certification for Two Biochemical Reagent Products

Stock News05-21

Beijing Leadman Biochemistry Co.,Ltd. (300289.SZ) has announced that two of its biochemical reagent products have recently obtained IVDR CE certification issued by the EU notified body TÜV SÜD. The certified Carbon Dioxide (CO2) Assay Kit (PEP-C method) is primarily used to assess the body's acid-base balance and aid in the diagnosis of respiratory and metabolic acid-base disorders. The Leucine Aminopeptidase (LAP) Assay Kit (L-leucine-p-nitroanilide substrate method) is a commonly used clinical test for liver function, mainly assisting in the diagnosis of hepatobiliary system diseases and reflecting conditions such as hepatocyte injury and biliary obstruction. According to the EU In Vitro Diagnostic Medical Devices Regulation, the products with IVDR CE certification have met the essential requirements for entry into the EU market. This development is expected to enhance the company's overall competitiveness in overseas markets and will positively impact its international expansion and future business operations.

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