Interleukin-10 Detection Kit (Chemiluminescence Method) - NMPA Registration 湘械注准20242400921
Access comprehensive regulatory information for Interleukin-10 Detection Kit (Chemiluminescence 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 湘械注准20242400921 and owned by Fosun Diagnostic Technology (Changsha) Co., Ltd. The device was approved on September 27, 2024.
This page provides complete registration details including registrant information, province location (Hunan), 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 interleukin-10 (IL-10) content in human serum and plasma samples. Clinically, it is used to monitor the body's immune status and inflammatory response.
供医疗机构用于人体血清和血浆样本中白介素-10（IL-10）含量的体外定量检测。临床上用于监测机体的免疫状态、炎症反应。
1. Store under 2~8°C, protect from light, and seal the storage conditions, and the kit is valid for 12 months. 2. After the reagent is enabled, it can be stable for 30 days when placed on the analyzer. 3. After the calibrator and quality control product are opened, they can be stored at 18~25°C for 6 hours; It can be stored at 2~8 °C and can be stable for 30 days.
1.在2～8℃、避光、密封的储存条件下保存，试剂盒有效期为12个月。2.试剂启用后，置于分析仪上可稳定30天。3.校准品、质控品开瓶后，在18～25℃条件下贮存，可稳定6小时；在2～8℃避光的条件下贮存，可稳定30天。