Total Prostate-Specific Antigen (TPSA) Assay Kit (Direct Chemiluminescence Method) - NMPA Registration 国械注准20243400262
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.
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。