Helicobacter pylori antibody detection test kit (latex immunoturbidimetric method)
- Device class
- Class III
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243402655
- Approval date
- December 30, 2024
- Expiry date
- December 29, 2029
- Name
- Shanghai Kehua Bio-Engineering Co., Ltd.上海科华生物工程股份有限公司
- Province/Region
- Shanghai上海
- Address
- 1189 Qinzhou North Road, Xuhui District, Shanghai上海市徐汇区钦州北路1189号
- Production address
- 上海市徐汇区钦州北路1189号
该产品用于体外定性检测人血清、血浆样本中幽门螺杆菌抗体.
该产品用于体外定性检测人血清、血浆样本中幽门螺杆菌抗体。
试剂1(R1):Good's缓冲液;试剂2(R2):Good's缓冲液、包被了幽门螺杆菌抗原(细菌)的聚苯乙烯粒子;校准品(a):Good's缓冲液;校准品(b-f):Good's缓冲液、幽门螺杆菌抗体(人源)(HBsAg、HIV1/2抗体、HCV抗体、梅毒螺旋体抗体检测均为阴性);质控品(L、H):Good's缓冲液、幽门螺杆菌抗体(人源)(HBsAg、HIV1/2抗体、HCV抗体、梅毒螺旋体抗体检测均为阴性).(具体内容详见产品说明书)
试剂1（R1）：Good’s缓冲液；试剂2（R2）：Good’s缓冲液、包被了幽门螺杆菌抗原(细菌)的聚苯乙烯粒子；校准品（a）：Good’s缓冲液；校准品(b-f)：Good’s缓冲液、幽门螺杆菌抗体（人源）（HBsAg、HIV1/2抗体、HCV抗体、梅毒螺旋体抗体检测均为阴性）；质控品(L、H)：Good’s缓冲液、幽门螺杆菌抗体（人源）（HBsAg、HIV1/2抗体、HCV抗体、梅毒螺旋体抗体检测均为阴性）。（具体内容详见产品说明书）
Store at 2~8 °C in the dark, valid for 24 months.
2～8℃避光保存，有效期24个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Helicobacter pylori antibody detection test kit (latex immunoturbidimetric method) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243402655 and owned by Shanghai Kehua Bio-Engineering Co., Ltd.. The device was approved on December 30, 2024.
This page provides complete registration details including registrant information, province location (Shanghai), 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.