Pure Global

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.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class II
京械注准20252400017
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 Number: 京械注准20252400017
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

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。

Device Classification
Device Class
Class II
Model Specifications
50 tests/box, 100 tests/box
50测试/盒,100测试/盒
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20252400017
Approval Date
January 14, 2025
Expiry Date
January 13, 2030
Registrant
Name
Beijing Beier Bioengineering Co., Ltd.
北京贝尔生物工程股份有限公司
Province/Region
Beijing
北京
Address
107, 1st floor, Building 1, No. 20 Chuangzhan Road, Daxing District, Beijing
北京市大兴区创展路20号院1号楼1层107
Production Facility
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
Structure and Composition
English

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。

Storage Conditions and Expiration
English

Store at 2~8°C, expiration date 12 months.

中文

保存于2~8℃,有效期12个月。