Total Prostate-Specific Antigen (TPSA) Assay Kit (Direct Chemiluminescence Method)
- Device class
- Class III
- Model specifications
- 100 servings/box; 50 servings/box.100人份/盒；50人份/盒。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243400262
- Approval date
- February 02, 2024
- Expiry date
- February 01, 2029
- 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
It is used for in vitro quantitative detection of total prostate-specific antigen (TPSA) in human serum and plasma samples. It is mainly used to monitor the efficacy of patients with malignant tumors, and cannot be used as the basis for early diagnosis or diagnosis of malignant tumors, and cannot be used for tumor screening in the general population.
用于体外定量检测人体血清、血浆样本中的总前列腺特异性抗原（TPSA）。主要用于对恶性肿瘤患者进行疗效监测，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。
The reagent consists of magnetic particles (M), conjugates (R1), calibrator (optional), and quality control (optional). (Please refer to the product manual for details)
试剂由磁微粒（M）、结合物（R1）、校准品（选配）、质控品（选配）组成。（具体内容详见产品说明书）
Store closed at 2~8°C, valid for 12 months.
2~8℃密闭保存，有效期为12个月。
- Changes
- 2024-02-07 注册人住所由:深圳市南山区招商街道科技大厦103C、503C、504D；科技大厦辅楼3A号、4A号; 生产地址由:深圳市南山区南海大道科技大厦主楼103C；科技大厦辅楼3A号、4A号; 注册人住所变更为: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; 生产地址变更为: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
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Total Prostate-Specific Antigen (TPSA) Assay Kit (Direct Chemiluminescence Method) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243400262 and owned by Goldsite Diagnostics Inc.. The device was approved on February 02, 2024.
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.