HE4 Test Kit for Human Epididymis Protein 4 (Chemiluminescence Immunoassay Method) - NMPA Registration 浙械注准20242401052
Access comprehensive regulatory information for HE4 Test Kit for Human Epididymis Protein 4 (Chemiluminescence Immunoassay Method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 浙械注准20242401052 and owned by Acon Biotech (Hangzhou) Co., Ltd.. The device was approved on January 16, 2024.
This page provides complete registration details including registrant information, province location (Zhejiang), 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 kit is used for in vitro quantitative detection of epididymal protein 4 (HE4) antigen in human serum or plasma samples. This reagent 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.
本试剂盒用于体外定量检测人血清或血浆样本中的附睾蛋白4（HE4）抗原的含量。本试剂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。
Reagent 1 (R1), Reagent 2 (R2), Reagent M, Calibrator (2 levels), Control L, Control M, Control H. (Please refer to the manual for details)
试剂1（R1），试剂2（R2），试剂M，校准品（2个水平），质控品L，质控品M，质控品H。（具体详见说明书）
This product is stored at 2~8°C and is valid for 12 months.
本产品于2～8℃下保存，有效期12个月。