Luteinizing Hormone Test Kit (Chemiluminescent Microparticle Immunoassay Method)
- Device class
- Class II
- Model specifications
- 100 servings/box; 200 servings/box; Calibrator (3 levels): 3; 0.5mL,3; 1mL; Controls (2 levels): 2; 0.5mL,2; 1mL.100人份/盒；200人份/盒；校准品（3水平）：3;0.5mL，3;1mL；质控品（2水平）：2;0.5mL，2;1mL。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400547
- Approval date
- October 16, 2024
- Expiry date
- October 15, 2029
- Name
- Baiding Biological Engineering (Beijing) Co., Ltd.柏定生物工程（北京）有限公司
- Province/Region
- Beijing北京
- Address
- No. 11, Dongying Road, Zhaoquanying Town, Shunyi District, Beijing北京市顺义区赵全营镇兆丰产业基地东盈路11号
- Production address
- 北京市顺义区赵全营镇兆丰产业基地东盈路11号
It is used for in vitro quantitative determination of luteinizing hormone content in human serum.
用于体外定量测定人血清中的促黄体生成素的含量。
名称主要组分浓度试剂1磷酸盐(PBS)缓冲液包被鼠源性荧光素单克隆抗体的免疫磁性微球0.05mol/L,pH7.4＞0.01%试剂2磷酸盐(PBS)缓冲液荧光素标记的鼠源性促黄体生成素单克隆抗体0.05mol/L,pH7.4＞0.1ug/mL试剂3磷酸盐(PBS)缓冲液吖啶酯标记的鼠源性促黄体生成素单克隆抗体0.05mol/L,pH7.4＞10ng/mL校准品(液体,3水平)三羟甲基氨基甲烷(Tris)缓冲液重组促黄体生成素抗原0.02mol/L,pH7.4水平1目标浓度:0IU/L水平2目标浓度:1IU/L水平3目标浓度:100IU/L质控品(液体,2水平)三羟甲基氨基甲烷(Tris)缓冲液重组促黄体生成素抗原0.02mol/L,pH7.4水平1目标浓度范围1.4IU/L～2.6IU/L水平2目标浓度范围:35IU/L～65IU/L校准信息卡二维码(内含校准信息)校准品、质控品靶值批特异,详见瓶标签.
名称主要组分浓度试剂1磷酸盐（PBS）缓冲液包被鼠源性荧光素单克隆抗体的免疫磁性微球0.05mol/L，pH7.4＞0.01%试剂2磷酸盐（PBS）缓冲液荧光素标记的鼠源性促黄体生成素单克隆抗体0.05mol/L，pH7.4＞0.1ug/mL试剂3磷酸盐（PBS）缓冲液吖啶酯标记的鼠源性促黄体生成素单克隆抗体0.05mol/L，pH7.4＞10ng/mL校准品（液体，3水平）三羟甲基氨基甲烷（Tris）缓冲液重组促黄体生成素抗原0.02mol/L，pH7.4水平1目标浓度：0IU/L水平2目标浓度：1IU/L水平3目标浓度：100IU/L质控品（液体，2水平）三羟甲基氨基甲烷（Tris）缓冲液重组促黄体生成素抗原0.02mol/L，pH7.4水平1目标浓度范围1.4IU/L～2.6IU/L水平2目标浓度范围：35IU/L～65IU/L校准信息卡二维码（内含校准信息）校准品、质控品靶值批特异，详见瓶标签。
2 °C ~ 8 °C protected from light, valid for 12 months.
2℃～8℃避光保存，有效期12个月。
Access comprehensive regulatory information for Luteinizing Hormone Test Kit (Chemiluminescent Microparticle Immunoassay Method) 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20242400547 and owned by Baiding Biological Engineering (Beijing) Co., Ltd.. The device was approved on October 16, 2024.
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.