Fluorescence immunochromatography analyzer
- Device class
- Class II
- Model specifications
- Tigsun-600
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20232220305
- Approval date
- May 08, 2023
- Expiry date
- May 07, 2028
- Name
- Beijing Tigsun Diagnostics Co., Ltd.北京泰格科信生物科技有限公司
- Province/Region
- Beijing北京
- Address
- Building 1, No. 16, District 1, Guba Road, Chengguan Street, Fangshan District, Beijing北京市房山区城关街道顾八路一区16号1幢
- Production address
- 北京市房山区城关街道顾八路一区16号1幢
Used in conjunction with fluorescent bead-labeled fluorescent immunochromatography reagents for in vitro quantitative detection of analytes in human samples.
与荧光微球标记的荧光免疫层析试剂配套使用，用于对人体样本中的待测物进行体外定量检测。
The analyzer is composed of host (including photoelectric detection module, scanning module, data processing module, liquid crystal display module, thermal printer, shell, etc.), information collection module, random software (release version number: 1), and power adapter.
分析仪由主机（包括光电检测模块、扫描模块、数据处理模块、液晶显示模块、热敏打印机、外壳等）、信息采集模块、随机软件（发布版本号：1）、电源适配器组成。
5 years
5年
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Fluorescence immunochromatography analyzer 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20232220305 and owned by Beijing Tigsun Diagnostics Co., Ltd.. The device was approved on May 08, 2023.
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.