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China NMPA legacy archive 粤械注准20252220093

Fully automatic specific protein biochemical analyzer

全自动特定蛋白生化分析仪
Goldsite Diagnostics Inc.Class IINMPAApproved January 21, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
ONTOP
Approval department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration information
Registration number
粤械注准20252220093
Approval date
January 21, 2025
Expiry date
January 20, 2030
Registrant
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 facility
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
Intended use
English

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。

Structure and composition
English

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。

Additional information
Appendix
产品技术要求
About this record

This static archive preserves historical registration fields and translations for Fully automatic specific protein biochemical analyzer, registration 粤械注准20252220093. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.