China NMPA legacy archive 吉械注准20252400070Carbohydrate antigen 19-9 detection reagent kit (chemiluminescence immunoassay)
糖类抗原19-9测定试剂盒(化学发光免疫分析法)
Dirui Industrial Co., Ltd.Class IINMPAApproved January 24, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class II
- Model specifications
- 1×50 test/box; 1×50 test/box (excluding calibrators and quality controls); 2×50 tests/box; 2×50 test/box (excluding calibrators and quality controls); 1×100 tests/box; 1×100 tests/box (excluding calibrators and quality controls); 2×100 tests/box; 2×100 tests/box (excluding calibrators and quality controls); 4×100 tests/box; 4×100 tests/box (excluding calibrators and quality controls); 1×200 tests/box; 1×200 tests/box (excluding calibrators and quality controls); 2×200 tests/box; 2×200 tests/box (excluding calibrators and quality controls).
- Approval department
- Jilin Provincial Drug Administration
1×50测试/盒；1×50测试/盒（不含校准品、质控品）； 2×50测试/盒；2×50测试/盒（不含校准品、质控品）； 1×100测试/盒；1×100测试/盒（不含校准品、质控品）； 2×100测试/盒；2×100测试/盒（不含校准品、质控品）； 4×100测试/盒；4×100测试/盒（不含校准品、质控品）； 1×200测试/盒；1×200测试/盒（不含校准品、质控品）； 2×200测试/盒；2×200测试/盒（不含校准品、质控品）。
吉林省药品监督管理局
Registration information
- Registration number
- 吉械注准20252400070
- Approval date
- January 24, 2025
- Expiry date
- February 03, 2030
Registrant
- Province/Region
- Jilin
- Address
- No. 95, Yunhe Street, Changchun High-tech Industrial Development Zone
吉林
长春市高新技术产业开发区云河街95号
Production facility
- Production address
- 长春市高新技术产业开发区云河街95号
Intended use
English
用于体外定量检测人血清或血浆中糖类抗原19-9（CA19-9）的含量。主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊断或确诊依据，不用于普通人群的肿瘤筛查。
Structure and composition
English
Reagent 1, Reagent 2, Reagent 3, Calibrator (high value, low value), Quality control (level 1, level 2). (Please refer to the manual for details)
中文
试剂1、试剂2、试剂3、校准品（高值、低值）、质控品（水平1、水平2）。（具体内容详见说明书）
Additional information
- Appendix
- 产品技术要求
About this record
This static archive preserves historical registration fields and translations for Carbohydrate antigen 19-9 detection reagent kit (chemiluminescence immunoassay), registration 吉械注准20252400070. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.