Carbohydrate antigen CA19-9 assay kit (chemiluminescence method with magnetic microspheres)
- Device class
- Class II
- Model specifications
- 100 tests/box.
- Approval department
- Beijing Municipal Drug Administration
- Registration number
- 京械注准20242400302
- Approval date
- June 06, 2024
- Expiry date
- June 05, 2029
- Province/Region
- Beijing
- Address
- No. 5 Xinghai Road, Beijing Economic and Technological Development Zone, Beijing
- Production address
- 北京市北京经济技术开发区兴海路 5 号 1 幢 2 层、6 层、B1 层、2 幢
本产品用于体外定量测定人血清中糖类抗原CA19-9含量。
试剂盒由试剂1号、试剂2号、磁分离试剂、校准品和质控品组成。CA19-9试剂1号(CA19-9-R1):含有FITC标记的抗CA19-9抗体(约0.25mu;g/mL)、保护剂和防腐剂的Tris缓冲液(浓度0.01mol/L,pH=8.0)。CA19-9抗体提取自杂交瘤细胞培养上清或感染小鼠腹水。CA19-9试剂2号(CA19-9-R2):含有ALP标记的抗CA19-9抗体(约0.5mu;g/mL)、保护剂和防腐剂的Tris缓冲液(浓度0.01mol/L,pH=8.0)。CA19-9抗体提取自杂交瘤细胞培养上清或感染小鼠腹水。CA19-9磁分离试剂(CA19-9-M):含有包被有抗FITC抗体的磁性微粒(约1mg/mL)、保护剂和防腐剂的Tris缓冲液(浓度0.1mol/L,pH=8.0)。抗FITC抗体提取自用FITC抗原免疫绵羊的血清。CA19-9校准品(CA19-9-STD):6个水平的液体校准品,含一定浓度CA19-9抗原、含牛血清白蛋白的Tris缓冲液、防腐剂配制而成。目标浓度分别约为0、12.3、37、111.1、333.3和1000U/mL。CA19-9质控品(CA19-9-QC):2个水平的液体质控品,含一定量CA19-9抗原的Tris缓冲液(浓度0.1mol/L,pH=8.0)。质控品的目标浓度约为40U/mL和150U/mL。注:校准品及质控品浓度具有批特异性,详见标签。
2 °C ~ 8 °C storage, valid for 12 months.
2℃~8℃保存,有效期12个月。
- Remark
- 原注册证号:国械注准20163400148
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