Free Prostate Specific Antigen (fPSA) Detection Kit (Magnetic Microparticle Chemiluminescence Method) - NMPA Registration 国械注准20213400068
Access comprehensive regulatory information for Free Prostate Specific Antigen (fPSA) Detection Kit (Magnetic Microparticle 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20213400068 and owned by Weifang Kanghua Biotechnology Co., Ltd. The device was approved on January 26, 2021.
This page provides complete registration details including registrant information, province location (Shandong), 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.
This product is used for in vitro quantitative detection of Free Prostate Specific Antigen (f-PSA) content in human serum samples. It 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 is not used for tumor screening in the general population.
本产品用于体外定量检测人血清样本中游离前列腺特异性抗原（Free Prostate Specific Antigen，f-PSA）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，不用于普通人群的肿瘤筛查。
Magnetic bead solutions, tracer conjugates, calibrators, controls. (Please refer to the manual for details)
磁性微球溶液、示踪物结合物、校准品、质控品。（具体内容详见说明书）
Store at 2~8°C, valid for 12 months.
2~8℃保存，有效期12个月。