Helicobacter pylori urease antibody test kit (chemiluminescence method) - NMPA Registration 国械注准20243401889
Access comprehensive regulatory information for Helicobacter pylori urease antibody test kit (chemiluminescence 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20243401889 and owned by Sichuan Orienter Biotechnology Co., Ltd.. The device was approved on September 24, 2024.
This page provides complete registration details including registrant information, province location (Sichuan), 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.
This kit is used for the qualitative detection of Helicobacter pylori urease antibody (Urease Ab) in human serum samples in vitro.
本试剂盒用于体外定性检测人血清样本中幽门螺杆菌尿素酶抗体（Urease Ab）。
试剂1(R1)、试剂2(R2)、试剂3(R3)、Urease Ab阴性对照(C0)、Urease Ab阳性对照(C1)、Urease Ab质控品(QCⅠ和QCⅡ). (具体内容详见产品说明书)
试剂1（R1）、试剂2（R2）、试剂3（R3）、Urease Ab阴性对照（C0）、Urease Ab阳性对照（C1）、Urease Ab质控品（QCⅠ和QCⅡ）。（具体内容详见产品说明书）
The kit is stored at 2~8°C and protected from light, and the validity period is 15 months.
试剂盒2～8℃密闭避光保存，有效期为15个月。