Leptin Assay Kit (Latex-Enhanced Immunoturbidimetric Method) - NMPA Registration 沪械注准20242400296
Access comprehensive regulatory information for Leptin Assay Kit (Latex-Enhanced Immunoturbidimetric 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 沪械注准20242400296 and owned by Shanghai Fosun LONG March MEDICAL Science Co., Ltd.. The device was approved on August 28, 2024.
This page provides complete registration details including registrant information, province location (Shanghai), 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 by medical institutions for in vitro quantitative detection of adiponectin concentration in human serum samples for auxiliary diagnosis.
供医疗机构用于对人血清样本中脂联素浓度的体外定量检测，作辅助诊断用。
试剂1(R1):Good's缓冲液、表面活性剂; 试剂2(R2):Good's缓冲液、胶乳包被抗脂联素抗体; 校准品S1-S5:脂联素、MOPSO缓冲液; 质控品C1、C2:脂联素、MOPSO缓冲液.
试剂1（R1）：Good's缓冲液、表面活性剂； 试剂2（R2）：Good's缓冲液、胶乳包被抗脂联素抗体； 校准品S1-S5：脂联素、MOPSO缓冲液； 质控品C1、C2：脂联素、MOPSO缓冲液。
1. Under the storage conditions of 2~8°C protected from light and sealed, the kit is valid for 12 months from the date of production. 2. Reagent 1 and Reagent 2 can be stable for 20 days after being placed on the analyzer. 3. After the calibrator and quality control product are activated, they can be stable for 6 hours when stored at 18~25°C and 20 days at 2~8°C.
1.在2～8℃避光、密封的储存条件下，试剂盒自生产之日起有效期为12个月。 2.试剂1和试剂2启用后，置于分析仪上可稳定20天。 3.校准品、质控品启用后，在18～25℃避光的条件下贮存可稳定6小时，在2～8℃避光的条件下可稳定20天。