Fully automatic specific protein biochemical analyzer
- Device class
- Class II
- Model specifications
- ONTOP
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20252220093
- Approval date
- January 21, 2025
- Expiry date
- January 20, 2030
- Name
- Goldsite Diagnostics Inc.深圳市国赛生物技术有限公司
- Province/Region
- Guangdong广东
- Address
- Building 1001, Guosai Science and Technology Building, No. 9 Rongtian Road, Jinsha Community, Kengzi Street, Pingshan District, Shenzhen深圳市坪山区坑梓街道金沙社区荣田路9号国赛科技大厦1号楼1001
- Production address
- 深圳市坪山区坑梓街道丹碧路与荣田路交汇处西南角深圳市国赛生物技术有限公司生产与研发厂区
与本公司配套的检测试剂共同使用，在临床上用于对来源于人体的全血、血清、血浆、尿液样本中的被分析物进行定量检测，包含蛋白质及多肽类检验、出凝血检查、免疫功能测定、感染性疾病实验检测、自身抗体检测、糖及其代谢物测定、肾脏疾病的实验诊断项目。
由主机和附件组成。主机主要由控制系统、检测系统、机械装置、输入输出部分、电源、软件组件组成。可选配样本进样模块、样本回收模块、地柜。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Fully automatic specific protein biochemical 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 粤械注准20252220093 and owned by Goldsite Diagnostics Inc.. The device was approved on January 21, 2025.
This page provides complete registration details including registrant information, province location (Guangdong), 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.