Interleukin-8 Assay Kit (Chemiluminescence Method)
- Device class
- Class II
- Model specifications
- Reagents: 50 tests/box; Reagents: 100 tests/box; Reagents: 2×50 tests/box; Reagents: 2×100 tests/box; Calibrator (optional): 3×1mL; Controls (optional): 2×1mL.试剂：50测试/盒；试剂：100测试/盒；试剂：2×50测试/盒；试剂：2×100测试/盒；校准品（可选购）：3×1mL；质控品（可选购）：2×1mL。
- Approval department
- Hunan Provincial Drug Administration湖南省药品监督管理局
- Registration number
- 湘械注准20242400920
- Approval date
- September 27, 2024
- Expiry date
- September 26, 2029
- Name
- Fosun Diagnostic Technology (Changsha) Co., Ltd复星诊断科技(长沙)有限公司
- Province/Region
- Hunan湖南
- Address
- No. 51, Changxing Road, Changsha High-tech Development Zone长沙高新开发区长兴路 51 号
- Production address
- 长沙高新开发区长兴路 51 号
It is used by medical institutions for the in vitro quantitative detection of interleukin-8 (IL-8) 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-8（IL-8）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。
Access comprehensive regulatory information for Interleukin-8 Assay 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20242400920 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.