Fully automatic chemiluminescence immunoassay analyzer - NMPA Registration 苏械注准20232220064
Access comprehensive regulatory information for Fully automatic chemiluminescence immunoassay analyzer in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 苏械注准20232220064 and owned by Suzhou Hokapi Biomedical Engineering Co., Ltd.. The device was approved on January 12, 2023.
This page provides complete registration details including registrant information, province location (Jiangsu), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
Based on the acridine ester direct chemiluminescence method, it is used in conjunction with supporting detection reagents for the qualitative or quantitative detection of analytes in serum, plasma and urine samples derived from humans, including hormones, tumor-related antigens, infectious diseases, autoantibodies, proteins and peptides, liver diseases, myocardial diseases, enzymes, vitamins, coagulation, and immune function items.
基于吖啶酯直接化学发光法，与配套的检测试剂共同使用，在临床上用于对来源于人体的血清、血浆、尿液样本中的被分析物进行定性或定量检测，包括激素、肿瘤相关抗原、感染性疾病、自身抗体、蛋白质及多肽类、肝病、心肌疾病、酶类、维生素、出凝血、免疫功能项目。
The automatic chemiluminescence immunoassay analyzer is composed of an optical path detection module, a circuit control module, a hydraulic circuit module, a mechanical transmission module, a computer module and random software (release version number: 01).
全自动化学发光免疫分析仪由光路检测模块、电路控制模块、液路模块、机械传动模块、计算机模块及随机软件（发布版本号：01）组成。