Group 1 - The company, Jiukang Bio, announced the receipt of medical device registration certificates from the Beijing Drug Administration for two products: the fully automatic coagulation analyzer (model MDC7600) and the fully automatic chemiluminescence immunoassay analyzer (model Gi 6000) [1] - The fully automatic coagulation analyzer is designed for quantitative analysis of substances in human samples when used with compatible reagents [1] - The fully automatic chemiluminescence immunoassay analyzer utilizes an indirect chemiluminescence method based on AMPPD and alkaline phosphatase, and is used in clinical settings for qualitative or quantitative detection of analytes in various human samples, including serum, plasma, whole blood, urine, and cerebrospinal fluid [1] Group 2 - The analytes that can be detected by the fully automatic chemiluminescence immunoassay analyzer include vitamins, amino acids, drug concentrations, hormones, myocardial diseases, infectious diseases, autoantibodies, tumor-related antigens, proteins and peptides, kidney diseases, liver diseases, immune function assessments, allergen-related projects, coagulation tests, and other enzyme assays [1]
九强生物全自动凝血分析仪等产品取得医疗器械注册证书