China NMPA legacy archive 国械注准20243402655Helicobacter pylori antibody detection test kit (latex immunoturbidimetric method)
- Device class
- Class III
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243402655
- Approval date
- December 30, 2024
- Expiry date
- December 29, 2029
- Province/Region
- Shanghai
- Address
- 1189 Qinzhou North Road, Xuhui District, Shanghai
- Production address
- 上海市徐汇区钦州北路1189号
该产品用于体外定性检测人血清、血浆样本中幽门螺杆菌抗体.
该产品用于体外定性检测人血清、血浆样本中幽门螺杆菌抗体。
试剂1(R1):Good's缓冲液;试剂2(R2):Good's缓冲液、包被了幽门螺杆菌抗原(细菌)的聚苯乙烯粒子;校准品(a):Good's缓冲液;校准品(b-f):Good's缓冲液、幽门螺杆菌抗体(人源)(HBsAg、HIV1/2抗体、HCV抗体、梅毒螺旋体抗体检测均为阴性);质控品(L、H):Good's缓冲液、幽门螺杆菌抗体(人源)(HBsAg、HIV1/2抗体、HCV抗体、梅毒螺旋体抗体检测均为阴性).(具体内容详见产品说明书)
试剂1（R1）：Good’s缓冲液；试剂2（R2）：Good’s缓冲液、包被了幽门螺杆菌抗原(细菌)的聚苯乙烯粒子；校准品（a）：Good’s缓冲液；校准品(b-f)：Good’s缓冲液、幽门螺杆菌抗体（人源）（HBsAg、HIV1/2抗体、HCV抗体、梅毒螺旋体抗体检测均为阴性）；质控品(L、H)：Good’s缓冲液、幽门螺杆菌抗体（人源）（HBsAg、HIV1/2抗体、HCV抗体、梅毒螺旋体抗体检测均为阴性）。（具体内容详见产品说明书）
Store at 2~8 °C in the dark, valid for 24 months.
2～8℃避光保存，有效期24个月。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for Helicobacter pylori antibody detection test kit (latex immunoturbidimetric method), registration 国械注准20243402655. It does not establish current authorization or complete current product details.
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