Fully automatic chemiluminescence immunoassay analyzer
- Device class
- Class II
- Model specifications
- IAC-200、IA-120、IA-120A、IA-120B、IA-120C、IA-120D、IA-120E、IA-600
- Approval department
- Guangxi Zhuang Autonomous Region Drug Administration
- Registration number
- 桂械注准20242220373
- Approval date
- January 14, 2025
- Expiry date
- November 17, 2029
- Province/Region
- Guangxi
- Address
- No. D-07, Information Industrial Park, Guilin High-tech Zone
- Production address
- 桂林市七星区东环路东侧GX-G08一号楼1层、2层和二号楼;深圳市光明区光明大道与东长路交叉口东南侧南太云创谷园区5栋1001、1002、1101-1110、1201-1210号房屋(委托生产)
该产品采用基于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、血浆和尿液样本中的被分析物进行定性或定量检测,包括激素、糖尿病、心肌标志物、肿瘤标志物、感染性疾病等相关项目,其检测结果作为临床诊断的参考依据,最终的诊断结果需由医生确定.
该产品采用基于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、血浆和尿液样本中的被分析物进行定性或定量检测,包括激素、糖尿病、心肌标志物、肿瘤标志物、感染性疾病等相关项目,其检测结果作为临床诊断的参考依据,最终的诊断结果需由医生确定。
It consists of an analysis module, an operation department, accessories and consumables. The analysis module comprises a sample processing module, a reagent processing module, a reaction cup transfer module, a sample reagent dispensing module, a reaction solution mixing module, a reaction module and a substrate solution module; The operation department includes industrial computer, touch screen, automatic chemiluminescence immunoassay analyzer software; Accessories and consumables include disposable reactor cups and solid waste bins.
由分析模块、操作部、附件及耗材组成。其中分析模块包括样本处理模块、试剂处理模块、反应杯转运模块、样本试剂分注模块、反应液混匀模块、反应模块和底物液模块;操作部包括工控机、触控屏、全自动化学发光免疫分析仪软件;附件及耗材包括一次性反应杯和固体废物桶。
- Remark
- 受托生产企业:深圳迎凯生物科技有限公司;统一社会信用代码:91440300MA5DQR193Q
- Changes
- 2025年01月14日 生产地址由“桂林市七星区东环路东侧GX-G08一号楼1层、2层和二号楼”变更为“桂林市七星区东环路东侧GX-G08一号楼1层、2层和二号楼;深圳市光明区光明大道与东长路交叉口东南侧南太云创谷园区5栋1001、1002、1101-1110、1201-1210号房屋(委托生产)”。
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