Helicobacter pylori IgG antibody detection reagent (fluorescence immunoassay)
- Device class
- Class III
- Model specifications
- 1 serving/box, 10 servings/box, 25 servings/box, 50 servings/box, 100 servings/box.1人份/盒、10人份/盒、25人份/盒、50人份/盒、100人份/盒。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243400380
- Approval date
- February 21, 2024
- Expiry date
- February 20, 2029
- Name
- Acon Biotech (Hangzhou) Co., Ltd.艾康生物技术（杭州）有限公司
- Province/Region
- Zhejiang浙江
- Address
- No. 210, Zhenzhong Road, West Lake District, Hangzhou杭州市西湖区振中路210号
- Production address
- 杭州市西湖区振中路210号；杭州市余杭区前程路2号1幢A区、3幢1-2F A区、3-4F
This reagent is used for the qualitative detection of Helicobacter pylori IgG antibody in human serum or plasma samples in vitro.
本试剂用于体外定性检测人血清或血浆样本中的幽门螺杆菌IgG抗体。
Test card, sample diluent, QR code. (Please refer to the product manual for details)
检测卡、样本稀释液、二维码。（具体内容详见产品说明书）
Store in a dry place at 2 °C ~ 30 °C in the dark, valid for 12 months.
2℃～30℃避光干燥处保存，有效期12个月。
- Changes
- 2024-02-28 变更注册证载明的生产地址由杭州市西湖区振中路210号;变更为：杭州市西湖区振中路210号；杭州市余杭区前程路2号1幢A区、3幢1-2F A区、3-4F
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Helicobacter pylori IgG antibody detection reagent (fluorescence immunoassay) 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20243400380 and owned by Acon Biotech (Hangzhou) Co., Ltd.. The device was approved on February 21, 2024.
This page provides complete registration details including registrant information, province location (Zhejiang), 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.