α-肿瘤坏死因子(TNF-α)测定试剂盒(磁微粒化学发光免疫分析法) - NMPA Registration 京械注准20252400017
Access comprehensive regulatory information for α-肿瘤坏死因子(TNF-α)测定试剂盒(磁微粒化学发光免疫分析法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20252400017 and owned by Beijing Beier Bioengineering Co., Ltd.. The device was approved on January 14, 2025.
This page provides complete registration details including registrant information, province location (Beijing), 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.
该产品用于体外定量测定人血清中的alpha;-肿瘤坏死因子(TNF-alpha;)含量。临床上用于炎症、免疫性疾病的辅助诊断。不用于恶性肿瘤患者的动态监测。
组分名称组成成分50测试/盒100测试/盒TNF-alpha;试剂1号(TNF-alpha;-R1)含有FITC标记的鼠抗人TNF-alpha;单克隆抗体、Tris缓冲液(pH8.0)4mL/瓶;16.5mL/瓶;1TNF-alpha;试剂2号(TNF-alpha;-R2)含有HRP标记的鼠抗人TNF-alpha;单克隆抗体、Tris缓冲液(pH8.0)4mL/瓶;16.5mL/瓶;1TNF-alpha;磁分离试剂(TNF-alpha;-M)含有标记羊抗FITC多克隆抗体的磁性微粒、Tris缓冲液(pH8.0)4mL/瓶;16.5mL/瓶;1TNF-alpha;校准品(TNF-alpha;-STD)含一定浓度的TNF-alpha;抗原的Tris缓冲液(pH7.4)。目标浓度分别为0、5、20、100、500和1000pg/mL0.55mL/瓶;60.55mL/瓶;6校准品条码包含校准品各点浓度信息的二维码1张1张校准品浓度具有批特异性,具体浓度详见每批的校准品条码。
Store at 2~8°C, expiration date 12 months.
保存于2~8℃,有效期12个月。

