25-Hydroxyvitamin D (25-OH VD) Test 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20252400194
- Approval date
- February 06, 2025
- Expiry date
- February 05, 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)血浆中的25-羟基维生素D的含量。临床上主要用于维生素D缺乏相关疾病的辅助诊断。
主要由试剂1(R1)、试剂2(R2)、试剂3(R3)、校准品1(CAL1)、校准品2(CAL2)和校准品3(CAL3)组成,其中试剂1(R1):25-OH Vitamin D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):25-OH Vitamin D复合物抗体(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,为乙酸盐缓冲液,含防腐剂(ProClin 300);校准品1(CAL1):MES缓冲液,含防腐剂(ProClin 300);校准品2(CAL2)和校准品3(CAL3):MES缓冲液,含25-OH Vitamin D (化学合成)、马血清、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。校准品首次使用后存放于2~8℃:可稳定56天。试剂首次使用后2~8℃在机存放:可稳定28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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