Free Prostate-Specific Antigen (FPSA) Assay Kit (Direct Chemiluminescence Method) - NMPA Registration 国械注准20243400180
Access comprehensive regulatory information for Free Prostate-Specific Antigen (FPSA) 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20243400180 and owned by Goldsite Diagnostics Inc.. The device was approved on January 26, 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 free prostate-specific antigen (FPSA) in human serum or plasma samples. It is mainly used for dynamic monitoring of prostate cancer patients 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.
用于体外定量检测人体血清或血浆样本中的游离前列腺特异性抗原（FPSA）。主要用于对前列腺癌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。
Magnetic particle (M), conjugate (R1), free prostate-specific antigen (FPSA) calibrator (optional), free prostate-specific antigen (FPSA) control (optional). (Please refer to the manual for details)
磁微粒（M）、结合物（R1）、游离前列腺特异性抗原（FPSA）校准品（选配）、游离前列腺特异性抗原（FPSA）质控品（选配）。（具体内容详见说明书）
Store tightly at 2-8°C and have an expiration date of 12 months.
2-8℃密闭保存，有效期为12个月。