Neuron-specific enolase (NSE) assay kit (magnetic chemiluminescence method) - NMPA Registration 鲁械注准20242401070
Access comprehensive regulatory information for Neuron-specific enolase (NSE) assay kit (magnetic chemiluminescence 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 鲁械注准20242401070 and owned by Weihai Weigao BIOTECHNOLOGY Co., Ltd.. The device was approved on December 05, 2024.
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.
用于体外定量检测人血清中的神经元特异性烯醇化酶含量.主要用于对已确诊的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,不宜用于普通人群的肿瘤筛查.
用于体外定量检测人血清中的神经元特异性烯醇化酶含量。主要用于对已确诊的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，不宜用于普通人群的肿瘤筛查。
测神经元特异性烯醇化酶磁微粒:含有1mg磁微粒标记20μgNSE抗体的液体; 测神经元特异性烯醇化酶示踪结合物:含有10mol吖啶酯标记1mol NSE抗体的溶液; 样本稀释液:含有1%牛血清白蛋白的磷酸盐缓冲液; 校准品1:用含有低浓度NSE纯品的冻干疏松体,浓度有批特异性,其浓度通过扫描标签获得,浓度值不低于5ng/mL; 校准品2:用含有高浓NSE纯品的冻干疏松体,浓度有批特异性,其浓度通过扫描标签获得,浓度值不低于50ng/mL; 质控品:用含有一定浓度NSE纯品的冻干疏松体,浓度有批特异性,其浓度在5ng/mL-100ng/mL范围内,具体范围见对应批号的标签.
测神经元特异性烯醇化酶磁微粒：含有1mg磁微粒标记20μgNSE抗体的液体； 测神经元特异性烯醇化酶示踪结合物：含有10mol吖啶酯标记1mol NSE抗体的溶液； 样本稀释液：含有1%牛血清白蛋白的磷酸盐缓冲液； 校准品1：用含有低浓度NSE纯品的冻干疏松体，浓度有批特异性，其浓度通过扫描标签获得，浓度值不低于5ng/mL； 校准品2：用含有高浓NSE纯品的冻干疏松体，浓度有批特异性，其浓度通过扫描标签获得，浓度值不低于50ng/mL； 质控品：用含有一定浓度NSE纯品的冻干疏松体，浓度有批特异性，其浓度在5ng/mL-100ng/mL范围内，具体范围见对应批号的标签。
Store at 2~8°C in the dark, valid for 14 months.
2~8℃避光保存，有效期14个月。