China NMPA legacy archive 国械注准20243400608Hepatitis E virus IgM antibody test kit (chemiluminescence method)
- Device class
- Class III
- Model specifications
- 50 servings/box, 2×50 servings/box, 100 servings/box, 2×100 servings/box, 200 servings/box, 2×200 servings/box.
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243400608
- Approval date
- March 28, 2024
- Expiry date
- March 27, 2029
- Province/Region
- Shanghai
- Address
- 1189 Qinzhou North Road, Xuhui District, Shanghai
- Production address
- 上海市徐汇区桂平路701号
This product is used for the in vitro qualitative detection of hepatitis E virus IgM antibody (Anti-HEV IgM) in human serum or plasma.
本产品用于体外定性检测人血清或血浆中的戊型肝炎病毒IgM抗体（Anti-HEV IgM）。
Reagent 1, Reagent 2, Reagent 3, Negative Quality Control, Positive Quality Control, Calibration Product B. (Please refer to the product manual for details)
试剂1、试剂2、试剂3、阴性质控、阳性质控、定标品B。（具体内容详见产品说明书）
Store at 2~8 °C, avoid freezing, valid for 12 months.
2~8℃储存，避免冷冻，有效期12个月。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for Hepatitis E virus IgM antibody test kit (chemiluminescence method), registration 国械注准20243400608. It does not establish current authorization or complete current product details.
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