China NMPA legacy archive 国械注准20243401889Helicobacter pylori urease antibody test kit (chemiluminescence method)
- 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.
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243401889
- Approval date
- September 24, 2024
- Expiry date
- September 23, 2029
- Province/Region
- Sichuan
- Address
- No. 9, Kangqiang 4th Road, Chengdu High-tech Zone
- Production address
- 成都高新区康强四路9号W2、W7
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。
- Appendix
- 产品技术要求、说明书
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