国械注准20243401889

Helicobacter pylori urease antibody test kit (chemiluminescence method)

幽门螺杆菌尿素酶抗体检测试剂盒（化学发光法）

Sichuan Orienter Biotechnology Co., Ltd.·Class III·NMPA·Approved September 24, 2024

Device classification

Device class: Class III
Model specifications: 50 tests/box, control: 0.5mL×2;2×50 test/box, control: 0.5mL×2;4×50 test/box, control: 1.0mL×2;100 test/box, control: 0.5mL×2;200 test/box, control: 1.0mL×2;300 test/box, control: 1.0mL×2;400 test/box, control: 1.0mL×2;50 test/box, control: 0.5mL×2, Control: 0.5mL×2;2×50 test/box, Control: 0.5mL×2, Control: 1.0mL×2;4×50 test/box, Control: 1.0mL×2, Control: 2.0mL×2;100 test/box, Control: 0.5mL×2, Control: 1.0mL×2;200 test/box, Control: 1.0mL×2, Control: 2.0mL×2;300 test/box, Control: 1.0mL×22. Control: 2.0mL×2;400 test/box, control: 1.0mL×2, control: 2.0mL×2.
50 测试/盒，对照品：0.5mL×2；2×50 测试/盒，对照品：0.5mL×2；4×50 测试/盒，对照品：1.0mL×2；100 测试/盒，对照品：0.5mL×2；200 测试/盒，对照品：1.0mL×2；300 测试/盒，对照品：1.0mL×2；400 测试/盒，对照品：1.0mL×2；50 测试/盒，对照品：0.5mL×2，质控品：0.5mL×2；2×50 测试/盒，对照品：0.5mL×2，质控品：1.0mL×2；4×50 测试/盒，对照品：1.0mL×2，质控品：2.0mL×2；100 测试/盒，对照品：0.5mL×2，质控品：1.0mL×2；200 测试/盒，对照品：1.0mL×2，质控品：2.0mL×2；300 测试/盒，对照品：1.0mL×2，质控品：2.0mL×2；400 测试/盒，对照品：1.0mL×2，质控品：2.0mL×2。
Approval department: State Drug Administration
国家药品监督管理局

Registration information

Registration number: 国械注准20243401889
Approval date: September 24, 2024
Expiry date: September 23, 2029

Registrant

Name: Sichuan Orienter Biotechnology Co., Ltd.
四川沃文特生物技术有限公司
Province/Region: Sichuan
四川
Address: No. 9, Kangqiang 4th Road, Chengdu High-tech Zone
成都高新区康强四路9号

Production facility

Production address: 成都高新区康强四路9号W2、W7

Intended use

English

This kit is used for the qualitative detection of Helicobacter pylori urease antibody (Urease Ab) in human serum samples in vitro.

中文

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）。

Structure and composition

English

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)

中文

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）

Storage conditions and expiration

English

The kit is stored at 2~8°C and protected from light, and the validity period is 15 months.

中文

试剂盒2～8℃密闭避光保存，有效期为15个月。

Additional information

Appendix: 产品技术要求、说明书

About this record

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.