Fully automatic chemiluminescence immunoassay analyzer
- Device class
- Class II
- Model specifications
- SIKMA-i2000
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20232220727
- Approval date
- November 20, 2023
- Expiry date
- November 19, 2028
- Name
- Beijing SenMeiXiKeMa Biotechnology Co., Ltd.北京森美希克玛生物科技有限公司
- Province/Region
- Beijing北京
- Address
- 4th Floor, Building 1, Yard 85, Kechuang 6th Street, Beijing Economic and Technological Development Zone, Beijing (Yizhuang Group, High-end Industrial Area, Beijing Pilot Free Trade Zone)北京市北京经济技术开发区科创六街85号院1号楼4层(北京自贸试验区高端产业片区亦庄组团)
- Production address
- 北京市北京经济技术开发区科创六街85号院1号楼4层
The direct chemiluminescence method based on acridine ester is used together with appropriate detection reagents for qualitative or quantitative detection of analytes derived from human samples, including hormones, tumor-related antigens, infectious diseases, liver and kidney diseases, myocardial diseases, diabetic immune function, allergens, autoantibodies, proteins and peptides, bone metabolism, vitamins, amino acid and blood concentrations, coagulation tests, other enzymes and other related detection items.
采用基于吖啶酯的直接化学发光法，与适配的检测试剂共同使用，在临床上用于对来源于人体样本中的待测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、肝病及肾脏疾病、心肌疾病、糖尿病免疫功能、变应原、自身抗体、蛋白质及多肽类、骨代谢、维生素，氨基酸与血药浓度、出凝血检查、其它酶类等相关检测项目。
It is composed of a host, a display and an analyzer application software, in which the host is composed of a sampling module, a reaction module, a liquid circuit module, a cleaning and separation module, a temperature control module, a mechanical transmission module, an optical detection module and a circuit control module.
由主机、显示器、分析仪应用软件组成，其中主机由加样模块、反应模块、液路模块、清洗分离模块、温育温控模块、机械传动模块、光学检测模块、电路控制模块组成。
5 years
5年
- 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 京械注准20232220727 and owned by Beijing SenMeiXiKeMa Biotechnology Co., Ltd.. The device was approved on November 20, 2023.
This page provides complete registration details including registrant information, province location (Beijing), 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.