China NMPA legacy archive 吉械注准20252400027癌抗原72-4测定试剂盒(化学发光免疫分析法)
- 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
- Registration number
- 吉械注准20252400027
- Approval date
- January 02, 2025
- Expiry date
- January 13, 2030
- Province/Region
- Jilin
- Address
- No. 95, Yunhe Street, Changchun High-tech Industrial Development Zone
- Production address
- 长春市高新技术产业开发区云河街95号
It is used for the quantitative detection of cancer antigen 72-4 (CA72-4) content in human serum or plasma in vitro, mainly used for dynamic monitoring of patients with malignant tumors to assist in judging the disease process or treatment effect, and cannot be used as the basis for early diagnosis or diagnosis of malignant tumors, and cannot be used for tumor screening in the general population.
用于体外定量检测人血清或血浆中癌抗原72-4（CA72-4）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的依据，不能用于普通人群的肿瘤筛查。
试剂R1：CA72-4鼠单克隆抗体包被的磁颗粒 ≥0.03%；试剂R2：吖啶酯标记的CA72-4鼠单克隆抗体 ≥0.1µg/mL；试剂R3：PBS缓冲溶液；校准品（高值、低值）：添加人源CA72-4抗原的血清基质；质控品（水平1、水平2）：添加人源CA72-4抗原的血清基质。
- Appendix
- 产品技术要求
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