Testosterone assay kit (chemiluminescence magnetic particle method) - NMPA Registration 京械注准20242400140
Access comprehensive regulatory information for Testosterone assay kit (chemiluminescence magnetic particle 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20242400140 and owned by Beijing Lepu Medical Technology Co., Ltd.. The device was approved on April 02, 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.
It is used for the quantitative determination of testosterone content in human serum and plasma samples in vitro.
用于体外定量测定人血清、血浆样本中睾酮的含量。
名称包装规格/装量主要组成成分及含量25测试/盒2; 25测试/盒50测试/盒2; 50测试/盒100测试/盒2; 100测试/盒200测试/盒试剂1(R1)3.0mL/瓶; 13.0mL/瓶; 24.0mL/瓶; 14.0mL/瓶; 26.5mL/瓶; 16.5mL/瓶; 212.0mL/瓶; 1链霉亲合素包被的固相磁微粒试剂2(R2)3.0mL/瓶; 13.0mL/瓶; 24.0mL/瓶; 14.0mL/瓶; 26.5mL/瓶; 16.5mL/瓶; 212.0mL/瓶; 1吖啶酯(AE)标记的睾酮抗原载体蛋白试剂3(R3)3.0mL/瓶; 13.0mL/瓶; 24.0mL/瓶; 14.0mL/瓶; 26.5mL/瓶; 16.5mL/瓶; 212.0mL/瓶; 1生物素标记睾酮特异性抗体试剂4(R4)3.5mL/瓶; 13.5mL/瓶; 25.0mL/瓶; 15.0mL/瓶; 27.0mL/瓶; 17.0mL/瓶; 212.0mL/瓶; 1睾酮解离剂校准品(选配1)0.5mL/瓶; 30.5mL/瓶; 30.5mL/瓶; 30.5mL/瓶; 30.5mL/瓶; 30.5mL/瓶; 30.5mL/瓶; 320mMPB缓冲液,3个水平的校准品各1瓶,含有睾酮抗原,目标浓度0.05ng/mL,1ng/mL,12ng/mL校准品(选配2)0.5mL/瓶; 60.5mL/瓶; 60.5mL/瓶; 60.5mL/瓶; 60.5mL/瓶; 60.5mL/瓶; 60.5mL/瓶; 620mMPB缓冲液,6个水平的校准品各1瓶,含有睾酮抗原,目标浓度0.05ng/mL,0.2ng/mL,1ng/mL,2ng/mL,8ng/mL,16ng/mL质控品(选配1)0.5mL/瓶; 20.5mL/瓶; 20.5mL/瓶; 20.5mL/瓶; 20.5mL/瓶; 20.5mL/瓶; 20.5mL/瓶; 220mMPB缓冲液,2个水平的质控品各1瓶,含有睾酮抗原,目标浓度1ng/mL,5ng/mL校准品(选配3)1mL/瓶; 31mL/瓶; 31mL/瓶; 31mL/瓶; 31mL/瓶; 31mL/瓶; 31mL/瓶; 320mMPB缓冲液,3个水平的校准品各1瓶,含有睾酮抗原,目标浓度0.05ng/mL,1ng/mL,12ng/mL校准品(选配4)1mL/瓶; 61mL/瓶; 61mL/瓶; 61mL/瓶; 61mL/瓶; 61mL/瓶; 61mL/瓶; 620mMPB缓冲液,6个水平的校准品各1瓶,含有睾酮抗原,目标浓度0.05ng/mL,0.2ng/mL,1ng/mL,2ng/mL,8ng/mL,16ng/mL质控品(选配2)1mL/瓶; 21mL/瓶; 21mL/瓶; 21mL/瓶; 21mL/瓶; 21mL/瓶; 21mL/瓶; 220mMPB缓冲液,2个水平的质控品各1瓶,含有睾酮抗原,目标浓度1ng/mL,5ng/mL
名称包装规格/装量主要组成成分及含量25测试/盒2;25测试/盒50测试/盒2;50测试/盒100测试/盒2;100测试/盒200测试/盒试剂1（R1）3.0mL/瓶;13.0mL/瓶;24.0mL/瓶;14.0mL/瓶;26.5mL/瓶;16.5mL/瓶;212.0mL/瓶;1链霉亲合素包被的固相磁微粒试剂2（R2）3.0mL/瓶;13.0mL/瓶;24.0mL/瓶;14.0mL/瓶;26.5mL/瓶;16.5mL/瓶;212.0mL/瓶;1吖啶酯（AE）标记的睾酮抗原载体蛋白试剂3（R3）3.0mL/瓶;13.0mL/瓶;24.0mL/瓶;14.0mL/瓶;26.5mL/瓶;16.5mL/瓶;212.0mL/瓶;1生物素标记睾酮特异性抗体试剂4（R4）3.5mL/瓶;13.5mL/瓶;25.0mL/瓶;15.0mL/瓶;27.0mL/瓶;17.0mL/瓶;212.0mL/瓶;1睾酮解离剂校准品(选配1)0.5mL/瓶;30.5mL/瓶;30.5mL/瓶;30.5mL/瓶;30.5mL/瓶;30.5mL/瓶;30.5mL/瓶;320mMPB缓冲液，3个水平的校准品各1瓶，含有睾酮抗原，目标浓度0.05ng/mL，1ng/mL，12ng/mL校准品(选配2)0.5mL/瓶;60.5mL/瓶;60.5mL/瓶;60.5mL/瓶;60.5mL/瓶;60.5mL/瓶;60.5mL/瓶;620mMPB缓冲液，6个水平的校准品各1瓶，含有睾酮抗原，目标浓度0.05ng/mL，0.2ng/mL，1ng/mL，2ng/mL，8ng/mL，16ng/mL质控品（选配1）0.5mL/瓶;20.5mL/瓶;20.5mL/瓶;20.5mL/瓶;20.5mL/瓶;20.5mL/瓶;20.5mL/瓶;220mMPB缓冲液，2个水平的质控品各1瓶，含有睾酮抗原，目标浓度1ng/mL，5ng/mL校准品(选配3)1mL/瓶;31mL/瓶;31mL/瓶;31mL/瓶;31mL/瓶;31mL/瓶;31mL/瓶;320mMPB缓冲液，3个水平的校准品各1瓶，含有睾酮抗原，目标浓度0.05ng/mL，1ng/mL，12ng/mL校准品(选配4)1mL/瓶;61mL/瓶;61mL/瓶;61mL/瓶;61mL/瓶;61mL/瓶;61mL/瓶;620mMPB缓冲液，6个水平的校准品各1瓶，含有睾酮抗原，目标浓度0.05ng/mL，0.2ng/mL，1ng/mL，2ng/mL，8ng/mL，16ng/mL质控品（选配2）1mL/瓶;21mL/瓶;21mL/瓶;21mL/瓶;21mL/瓶;21mL/瓶;21mL/瓶;220mMPB缓冲液，2个水平的质控品各1瓶，含有睾酮抗原，目标浓度1ng/mL，5ng/mL
2°C~8°C storage, valid for 18 months.
2℃～8℃保存，有效期18个月。