Estradiol (E2) Detection Reagent Kit (Chemiluminescence Method)
- Device class
- Class II
- Model specifications
- 1×50人份/盒、2×50人份/盒、2×150人份/盒。
- Approval department
- Guangdong Provincial Drug Administration
- Registration number
- 粤械注准20252400029
- Approval date
- January 08, 2025
- Expiry date
- January 07, 2030
- Province/Region
- Guangdong
- Address
- Building 1, Yahuilong Biotechnology Factory, Baolong 2nd Road, Baolong Street, Longgang District, Shenzhen
- Production address
- 深圳市龙岗区宝龙街道宝龙二路亚辉龙生物科技厂区2栋
用于体外定量测定人血清和(或)血浆中雌二醇(E2)的含量。临床上主要用于卵巢疾病的辅助诊断。
由试剂1(R1)、试剂2(R2)、试剂3(R3)、试剂4(R4)、校准品1(CAL1)、校准品2(CAL2)、校准品3(CAL3)组成。其中试剂1(R1):雌二醇抗体(哺乳动物细胞表达)包被的超顺磁性微粒,含防腐剂(ProClin 300);试剂2(R2):雌二醇抗体(哺乳动物细胞表达)吖啶标记结合物,含防腐剂(ProClin 300);试剂3(R3):样本处理液,为磷酸盐缓冲液,含防腐剂(ProClin 300);试剂4(R4):测试稀释液,为MES缓冲液,含防腐剂(ProClin 300);校准品1(CAL1):Tris缓冲液,含蛋白稳定剂、防腐剂(ProClin 300);校准品2(CAL2):Tris缓冲液,含雌二醇(化学合成)、蛋白稳定剂、防腐剂(ProClin 300);校准品3(CAL3):Tris缓冲液,含雌二醇(化学合成)、蛋白稳定剂、防腐剂(ProClin 300)。
试剂及校准品未开封竖直存放于2~8℃:可稳定18个月。试剂首次使用后存放于2~8℃:可稳定28天。试剂首次使用后2~8℃在机存放:可稳定28天。校准品首次使用后存放于2~8℃:可稳定56天。校准品在室温(20~25℃)下,可稳定保存8小时。
- Appendix
- 产品技术要求、说明书
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