Dry fluorescence immunoassay analyzer
- Device class
- Class II
- Model specifications
- IFP-2000
- Approval department
- Sichuan Provincial Drug Administration四川省药品监督管理局
- Registration number
- 川械注准20232220274
- Approval date
- September 07, 2023
- Expiry date
- September 06, 2028
- Name
- Sichuan Xincheng Biological Co., Ltd.四川新健康成生物股份有限公司
- Province/Region
- Sichuan四川
- Address
- No. 101, Tianxin Road, Chengdu High-tech Zone成都市高新区天欣路101号
- Production address
- 成都市高新区天欣路101号2栋（不包含1楼1-6和1-9）和3栋1楼
It is used in conjunction with the fluorescent immunochromatography reagent labeled by the company for in vitro quantitative detection of analytes in human samples.
与本公司生产的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 instrument consists of a host (including a scanning control module, a photoelectric detection module (fluorescence), a data processing module, a display module, and a printer), a power adapter, and software (software release version: V1).
仪器由主机（包括扫描控制模块、光电检测模块（荧光）、数据处理模块、显示模块、打印机）、电源适配器、软件（软件发布版本：V1）组成。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Dry fluorescence immunoassay 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 川械注准20232220274 and owned by Sichuan Xincheng Biological Co., Ltd.. The device was approved on September 07, 2023.
This page provides complete registration details including registrant information, province location (Sichuan), 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.