Lambda light chain assay kit (immunoturbidimetry)
- Device class
- Class II
- Model specifications
- Reagent 1:1; 60mL, reagent 2:1; 20mL; Reagent 1:2; 60mL, reagent 2:2; 20mL; Reagent 1:1; 45mL, reagent 2:1; 15mL; Reagent 1:2; 45mL, reagent 2:2; 15mL; Reagent 1:1; 15mL, reagent 2:1; 5mL; Reagent 1:1; 30mL, reagent 2:1; 10mL; Reagent 1:2; 16.8mL, reagent 2:2; 5.6mL. Calibrator (optional): Level 1:1; 1mL, level 2:1; 1mL, level 3:1; 1mL, level 4:1; 1mL, level 5:1; 1mL. Controls (optional): Level 1:1; 1mL, level 2:1; 1mL.试剂1：1;60mL，试剂2：1;20mL； 试剂1：2;60mL，试剂2：2;20mL； 试剂1：1;45mL，试剂2：1;15mL； 试剂1：2;45mL，试剂2：2;15mL； 试剂1：1;15mL，试剂2：1;5mL； 试剂1：1;30mL，试剂2：1;10mL； 试剂1：2;16.8mL，试剂2：2;5.6mL。 校准品（选配）：水平1：1;1mL、水平2：1;1mL、水平3：1;1mL、水平4：1;1mL、水平5：1;1mL。 质控品（选配）：水平1：1;1mL、水平2：1;1mL。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20232400563
- Approval date
- September 13, 2023
- Expiry date
- September 12, 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, No. 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
It is used for the quantitative determination of lambda in human serum in vitro; The content of light chains.
用于体外定量测定人血清中lambda;轻链的含量。
compose concentration Reagent 1 Tris buffer (pH 6.0~9.0) 100mmol/L Polyethylene glycol 6000 10g/L Reagent 2 Tris buffer (pH 6.0~9.0) 100mmol/L Polyethylene glycol 6000 10g/L lambda; Light chain antibodies 0.15% Calibrators liquid, 5 levels (Optional) Tris buffer (pH 6.0~9.0) 20mmol/L Human serum 300mL/L lambda;-LC target concentration range Level 1: (0.1~0.5)g/L Level 2: (0.6~0.8) g/L Level 3: (1.3~1.9) g/L Level 4: (2.8~4.2) g/L Level 5: (5.5~7.5) g/L Quality controls Liquid, 2 levels (Optional) Tris buffer (pH 6.0~9.0) 20mmol/L Human serum 300mL/L lambda;-LC target concentration range Level 1: (1.1~2.1) g/L Level 2: (2.8~4.2) g/L The target value of the calibrator is batch-specific, see the target value list for details. The quality control quality control range is batch-specific, see the target value list for details.
组成 浓度 试剂1 Tris缓冲液(pH 6.0～9.0) 100mmol/L 聚乙二醇6000 10g/L 试剂2 Tris缓冲液(pH 6.0～9.0) 100mmol/L 聚乙二醇6000 10g/L lambda;轻链抗体 0.15% 校准品 液体,5水平 （选配） Tris缓冲液(pH 6.0～9.0) 20mmol/L 人血清 300mL/L lambda;-LC目标浓度范围 水平1：（0.1～0.5）g/L 水平2：（0.6～0.8）g/L 水平3：（1.3～1.9）g/L 水平4：（2.8～4.2）g/L 水平5：（5.5～7.5）g/L 质控品 液体,2水平 （选配） Tris缓冲液(pH 6.0～9.0) 20mmol/L 人血清 300mL/L lambda;-LC目标浓度范围 水平1：（1.1～2.1）g/L 水平2：（2.8～4.2）g/L 校准品靶值批特异，详见靶值单。质控品质控范围批特异，详见靶值单。
Store in the dark under the condition of 2 °C ~ 8 °C, there is
2℃～8℃条件下避光保存，有
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Lambda light chain assay kit (immunoturbidimetry) 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20232400563 and owned by Beijing SenMeiXiKeMa Biotechnology Co., Ltd.. The device was approved on September 13, 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.