China NMPA legacy archive 京械注准20252400017α-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）
- Device class
- Class II
- Model specifications
- 50 tests/box, 100 tests/box
- Approval department
- Beijing Municipal Drug Administration
- Registration number
- 京械注准20252400017
- Approval date
- January 14, 2025
- Expiry date
- January 13, 2030
- Province/Region
- Beijing
- Address
- 107, 1st floor, Building 1, No. 20 Chuangzhan Road, Daxing District, Beijing
- Production address
- 北京市大兴区创展路20号院，北京市大兴区仲景路15号院1号楼1层、2层202室、4层、5层
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。
This static archive preserves historical registration fields and translations 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）, registration 京械注准20252400017. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.