Total Prostate-Specific Antigen (tPSA) Assay Kit (Chemiluminescence Immunoassay)
- Device class
- Class III
- Model specifications
- 30 tests/box, 50 tests/box, 100 tests/box, 200 tests/box, 30 tests/box (C), 50 tests/box (C), 100 tests/box (C), 200 tests/box (C), 30 tests/box (Q), 50 tests/box (Q), 100 tests/box (Q), 200 tests/box (Q), 30 tests/box (CQ), 50 tests/box (CQ), 100 tests/box (CQ), 200 tests/box (CQ).30测试/盒、50测试/盒、100测试/盒、200测试/盒，30测试/盒(C)、 50测试/盒(C)、100测试/盒(C)、200测试/盒(C)，30测试/盒(Q)、50测试/盒(Q)、100测试/盒(Q)、200测试/盒(Q)，30测试/盒(CQ)、50测试/盒(CQ)、100测试/盒(CQ)、200测试/盒(CQ)。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20233401340
- Approval date
- September 15, 2023
- Expiry date
- September 14, 2028
- Name
- Rayto Life and Analytical Sciences Co., Ltd.深圳雷杜生命科学股份有限公司
- Province/Region
- Guangdong广东
- Address
- The second floor of Building 5, Software Park, No. 2, Gaoxin Zhongsan Road, Yuehai Street, Nanshan District, Shenzhen深圳市南山区粤海街道高新中三道二号软件园五号楼二层
- Production address
- 深圳市光明新区高新东片区双明大道南侧雷杜工业大厦
It is suitable for the quantitative determination of the content of total prostate-specific antigen (tPSA) in human serum or plasma in vitro, and is mainly used for dynamic monitoring of patients with malignant tumors to assist in judging the disease process or treatment effect, 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.
适用于体外定量测定人血清或血浆中总前列腺特异性抗原（tPSA）的含量，主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，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 kit consists of immunomagnetic beads (M), enzyme conjugate (R), calibrator 1, calibrator 2, control 1, and control 2. (Please refer to the manual for details)
试剂盒由免疫磁珠（M）、酶结合物（R）、校准品1、校准品2、质控品1、质控品2组成。（具体内容详见说明书）
This product is stored at 2°C~8°C and has an expiration date of 12 months.
本产品在2℃~8℃保存，有效期为12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Total Prostate-Specific Antigen (tPSA) Assay Kit (Chemiluminescence Immunoassay) 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20233401340 and owned by Rayto Life and Analytical Sciences Co., Ltd.. The device was approved on September 15, 2023.
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.