Helicobacter pylori antigen test kit (latex method)
- Device class
- Class III
- Model specifications
- 管型:1人份/盒、2人份/盒(1人份/袋×2)、5人份/盒(1人份/袋×5)、10人份/盒(1人份/袋×10)、20人份/盒(1人份/袋×20);卡塞型:1人份/盒、2人份/盒(1人份/袋×2)、5人份/盒(1人份/袋×5)、10人份/盒(1人份/袋×10)、20人份/盒(1人份/袋×20).管型：1人份/盒、2人份/盒（1人份/袋×2）、5人份/盒（1人份/袋×5）、10人份/盒（1人份/袋×10）、20人份/盒（1人份/袋×20）；卡塞型：1人份/盒、2人份/盒（1人份/袋×2）、5人份/盒（1人份/袋×5）、10人份/盒（1人份/袋×10）、20人份/盒（1人份/袋×20）。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243400453
- Approval date
- March 08, 2024
- Expiry date
- March 07, 2029
- Name
- Beijing Lepu Medical Technology Co., Ltd.北京乐普诊断科技股份有限公司
- Province/Region
- Beijing北京
- Address
- No. 37, Chaoqian Road, Science and Technology Park, Changping District, Beijing北京市昌平区科技园区超前路37号
- Production address
- 北京市昌平区科技园区超前路37号7-1楼三层、北京市昌平区超前路37号6幢101一层南区、北京市昌平区利祥路6号4幢、5幢、6幢
This product is used for the qualitative detection of Helicobacter pylori antigen in human fecal samples in vitro.
本产品用于体外定性检测人粪便样本中幽门螺杆菌抗原。
The caster type includes a test tube (including a test strip, sample processing solution, and a sampling stick) and a toilet paper, and a plug type includes a test card (including a test strip and a plastic plug), a sample handling liquid tube, a sampling stick, and a toilet paper. Please refer to the product manual for details.
管型包括检测管（包含试纸条、样本处理液、取样棒）、采便纸；卡塞型包括检测卡（包含试纸条、塑料卡塞）、样本处理液管、取样棒、采便纸。具体内容详见产品说明书。
4~30°C, dry and dark storage, valid for 18 months.
4～30℃，干燥避光储存，有效期18个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Helicobacter pylori antigen test kit (latex 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20243400453 and owned by Beijing Lepu Medical Technology Co., Ltd.. The device was approved on March 08, 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.