China NMPA legacy archive 苏械注准20242220364Fully automatic chemiluminescence immunoassay analyzer
- Device class
- Class II
- Model specifications
- H360S
- Approval department
- Jiangsu Provincial Drug Administration
- Registration number
- 苏械注准20242220364
- Approval date
- March 13, 2024
- Expiry date
- March 12, 2029
- Province/Region
- Jiangsu
- Address
- Room 501, Building B11, Bionanopark, No. 218 Xinghu Street, Suzhou Industrial Park
- Production address
- 苏州工业园区星湖街218号生物纳米园B11号楼4楼、5楼
This product is based on acridine ester direct chemiluminescence method and is used together with the matching kit produced by our company. It is clinically used for qualitative or quantitative detection of analytes derived from human serum, plasma, and urine samples, including hormones, tumor-related antigens, infectious diseases, autoantibodies, proteins and peptides, liver diseases, cardiomyocardial diseases, enzymes, immune function assays, coagulation, vitamins, and blood drugs.
该产品基于吖啶酯直接化学发光法，与本公司生产的配套试剂盒共同使用。在临床上用于对来源于人体血清、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、免疫功能测定、出凝血、维生素及血药项目。
The automatic chemiluminescence immunoassay analyzer is composed of an analysis module, a sample processing module and a fully automatic chemiluminescence immunoassay analyzer software (model: H360S, release version number: 01), in which the analysis module includes: reaction vessel loading and moving system, sample and reagent distribution system, reaction system, cleaning and separation system, measurement system, reagent storage system, electronic control system, and up to 4 analysis modules can be selected. The sample handling module includes a sample loading system and a conveyor system.
全自动化学发光免疫分析仪由分析模块、样本处理模块及全自动化学发光免疫分析仪软件（型号：H360S，发布版本号：01）组成，其中分析模块包括：反应杯装载移动系统、样本及试剂分配系统、反应系统、清洗分离系统、测量系统、试剂储存系统、电控系统；最多可选配4个分析模块。样本处理模块包括样本装载系统及输送系统。
The declared product is an active product
申报产品为有源产品
- Appendix
- 产品技术要求
This static archive preserves historical registration fields and translations for Fully automatic chemiluminescence immunoassay analyzer, registration 苏械注准20242220364. It does not establish current authorization or complete current product details.
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