Carbohydrate antigen CA19-9 assay kit (chemiluminescence method with magnetic microspheres)
- Device class
- Class II
- Model specifications
- 100 tests/box.100测试/盒。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400302
- Approval date
- June 06, 2024
- Expiry date
- June 05, 2029
- Name
- Beijing Leadman Biochemistry Co., Ltd.北京利德曼生化股份有限公司
- Province/Region
- Beijing北京
- Address
- No. 5 Xinghai Road, Beijing Economic and Technological Development Zone, Beijing北京市北京经济技术开发区兴海路5号
- 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
Access comprehensive regulatory information for Carbohydrate antigen CA19-9 assay kit (chemiluminescence method with magnetic microspheres) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242400302 and owned by Beijing Leadman Biochemistry Co., Ltd.. The device was approved on June 06, 2024.
This page provides complete registration details including registrant information, province location (Beijing), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.