China NMPA legacy archive 京械注准20242220634Fully automatic chemiluminescence immunoassay analyzer
- Device class
- Class II
- Model specifications
- BR-2000.
- Approval department
- Beijing Municipal Drug Administration
- Registration number
- 京械注准20242220634
- Approval date
- November 11, 2024
- Expiry date
- November 10, 2029
- Province/Region
- Beijing
- Address
- 107, 1st floor, Building 1, No. 20 Chuangzhan Road, Daxing District, Beijing
- Production address
- 北京市大兴区创展路20号院
该产品基于化学发光法,与配套的检测试剂共同使用,在临床上用于对来源于人体血清、 血浆或者其他体液样本中的被分析物进行体外定性或定量检测.
该产品基于化学发光法，与配套的检测试剂共同使用，在临床上用于对来源于人体血清、 血浆或者其他体液样本中的被分析物进行体外定性或定量检测。
BR-2000主要由主机(包含样本架输送模块、反应杯配备模块、加样模块、试剂处理模块、温育反应模块、清洗分离模块、光学检测模块、电路控制模块)、软件组件(版本号:1)及附件(包含样本架、液路管)组成.
BR-2000主要由主机（包含样本架输送模块、反应杯配备模块、加样模块、试剂处理模块、温育反应模块、清洗分离模块、光学检测模块、电路控制模块）、软件组件（版本号：1）及附件（包含样本架、液路管）组成。
10 years
10年
- Appendix
- 产品技术要求
This static archive preserves historical registration fields and translations for Fully automatic chemiluminescence immunoassay analyzer, registration 京械注准20242220634. It does not establish current authorization or complete current product details.
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