Fully automatic chemiluminescence immunoassay analyzer
- Device class
- Class II
- Model specifications
- SZY-CL9000
- Approval department
- Hubei Provincial Drug Administration湖北省药品监督管理局
- Registration number
- 鄂械注准20242225327
- Approval date
- December 26, 2024
- Expiry date
- December 25, 2029
- Name
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.武汉生之源生物科技股份有限公司
- Province/Region
- Hubei湖北
- Address
- 1st, 2nd and 3rd floor, No. 818 Gaoxin Avenue, Wuhan East Lake New Technology Development Zone, No. 818 High-tech Medical Equipment Park武汉东湖新技术开发区高新大道818号高科医疗器械园B11号1楼、2楼、3楼
- Production address
- 武汉东湖新技术开发区高新大道818号高科医疗器械园B11号3楼
The indirect chemiluminescence method based on AMPPD and alkaline phosphatase, together with supporting detection reagents, is used in clinical practice for the qualitative or quantitative detection of analytes in serum and plasma samples derived from humans, including hormones, autoantibodies, proteins and peptides, myocardial markers, tumor markers, and infectious diseases.
采用基于AMPPD和碱性磷酸酶的间接化学发光法，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和血浆样本中的被分析物进行定性或者定量检测，包括激素、自身抗体、蛋白质及多肽、心肌标志物、肿瘤标志物、感染性疾病的相关项目。
全自动化学发光免疫分析仪由样本台、轨道系统、分析仪、控制系统、附件及耗材组成.其中分析仪由试剂处理系统、反应杯转运系统、样本试剂分注系统、反应液混匀系统、磁分离系统、底物系统、光测及反应系统组成;控制系统由触控一体机、手持式条码仪、全自动化学发光免疫分析仪软件(嵌入式控制型软件组件,版本:V1)组成;附件及耗材为电线组件、网线、废料箱、废液桶、废液桶盖组件、清洗液桶、一次性反应杯.
全自动化学发光免疫分析仪由样本台、轨道系统、分析仪、控制系统、附件及耗材组成。其中分析仪由试剂处理系统、反应杯转运系统、样本试剂分注系统、反应液混匀系统、磁分离系统、底物系统、光测及反应系统组成；控制系统由触控一体机、手持式条码仪、全自动化学发光免疫分析仪软件（嵌入式控制型软件组件，版本:V1）组成；附件及耗材为电线组件、网线、废料箱、废液桶、废液桶盖组件、清洗液桶、一次性反应杯。
- Appendix
- 产品技术要求
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 鄂械注准20242225327 and owned by Wuhan Life Origin Biotech Joint Stock Co., Ltd.. The device was approved on December 26, 2024.
This page provides complete registration details including registrant information, province location (Hubei), 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.