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Cytokine Combination Detection Kit (Flow Cytometry Fluorescence Method) - NMPA Registration 湘械注准20232400876

Access comprehensive regulatory information for Cytokine Combination Detection Kit (Flow Cytometry Fluorescence 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20232400876 and owned by Changsha Micron Biotechnology Co., Ltd.. The device was approved on September 07, 2023.

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.

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Class II
湘械注准20232400876
Cytokine Combination Detection Kit (Flow Cytometry Fluorescence Method)
细胞因子联合检测试剂盒(流式荧光发光法)
NMPA Registration Number: 湘械注准20232400876
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Pricing
Intended Use
English

This kit is used for the quantitative detection of the expression of IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-17, IFN-α, IFN-γ, TNF-α and IL-1β in human serum and plasma in vitro, and is mainly used to detect the inflammatory immune response of the body.

中文

本试剂盒用于体外定量检测人血清、血浆中IL-2、IL-4、IL-5、IL-6、IL-8、IL-10、IL-12p70、IL-17、IFN-α、IFN-γ、TNF-α、IL-1β的表达,临床上主要用于检测机体的炎性免疫反应。

Device Classification
Device Class
Class II
Model Specifications
50 servings/box, 80 servings/box, 100 servings/box, 200 servings/box
50人份/盒、80人份/盒、100人份/盒、200人份/盒
Approval Department
Hunan Provincial Drug Administration
湖南省药品监督管理局
Registration Information
Registration Number
湘械注准20232400876
Approval Date
September 07, 2023
Expiry Date
September 06, 2028
Registrant
Name
Changsha Micron Biotechnology Co., Ltd.
长沙市微米生物科技有限公司
Province/Region
Hunan
湖南
Address
Room 1001, 1002, 1007, 1008, Standard Factory Building, Shanhe Pharmaceutical and Health Industrial Park, No. 1048, Zhongqing Road, Shaping Street, Kaifu District, Changsha
长沙市开福区沙坪街道中青路1048号山河医药健康产业园标准厂房3栋1001、1002、1007、1008房
Production Facility
Production Address
长沙市开福区沙坪街道中青路1048号山河医药健康产业园第3栋201房
Structure and Composition
English

Consists of a capture bead mix, fluorescent PE-labeled detection reagents, sample diluent, bead buffer, 10× PBS, and calibrator (optional). The specific components are shown in the attached sheet.

中文

由捕获微球混合液、荧光PE标记的检测试剂、样本稀释液、微球缓冲液、10×PBS和校准品(选配)组成。具体组成成分见附页。

Storage Conditions and Expiration
English

The kit is sealed at 2°C~8°C and stored in the dark, and the validity period is 12 months. After the reagent is opened, it can be stored at 2°C~8°C in the dark, and can be stored for 30 days. After the calibrator is reconstituted, it is placed at 2°C~8°C, and it is effective to use it within 4 hours, and it is not recommended to use the remaining calibrator after reconstitution.

中文

试剂盒2℃~8℃密封避光保存,有效期12个月。试剂开瓶后2℃~8℃避光保存,可保存30天。校准品复溶后置于2℃~8℃,4小时内使用有效,不建议使用复溶后剩余校准品。

Additional Information
Appendix
产品技术要求、说明书