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α肿瘤坏死因子(TNFα)测定试剂盒(磁微粒化学发光免疫分析法) - NMPA Registration 京械注准20242400386

Access comprehensive regulatory information for α肿瘤坏死因子(TNFα)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20242400386 and owned by Beijing Savant Biotechnology Co., Ltd.. The device was approved on July 22, 2024.

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.

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Class II
京械注准20242400386
α肿瘤坏死因子(TNFα)测定试剂盒(磁微粒化学发光免疫分析法)
α肿瘤坏死因子（TNFα）测定试剂盒（磁微粒化学发光免疫分析法）
NMPA Registration Number: 京械注准20242400386
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Pricing
Intended Use
English

本试剂盒用于体外定量测定人血清中α肿瘤坏死因子(TNFα)的含量.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.

中文

本试剂盒用于体外定量测定人血清中α肿瘤坏死因子（TNFα）的含量。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
100 servings/box, 200 servings/box, 100 servings; 5/box.
100人份/盒、200人份/盒、100人份;5/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20242400386
Approval Date
July 22, 2024
Expiry Date
July 21, 2029
Registrant
Name
Beijing Savant Biotechnology Co., Ltd.
北京华科泰生物技术股份有限公司
Province/Region
Beijing
北京
Address
101-301, 302, 3rd Floor, Building 4, No. 8 Liangshuihe 2nd Street, Beijing Economic and Technological Development Zone, Beijing (Yizhuang Group, High-end Industrial Area, Beijing Pilot Free Trade Zone)
北京市北京经济技术开发区凉水河二街8号院4号楼3层101-301、302（北京自贸试验区高端产业片区亦庄组团）
Production Facility
Production Address
天津市北辰区永康道12号2号楼1层、4层（委托生产）
Storage Conditions and Expiration
English

在2℃～8℃储存,有效期为18个月.严禁冷冻,避免倒置.

中文

在2℃～8℃储存，有效期为18个月。严禁冷冻，避免倒置。

Additional Information
Appendix
产品技术要求、说明书