China NMPA legacy archive 吉械注准20252400064Neuron-specific enolase determination reagent kit (chemiluminescence immunoassay method)
- 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20252400064
- Approval date
- January 24, 2025
- Expiry date
- February 06, 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 neuron-specific enolase (NSE) content in human serum in vitro, which is 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中神经元特异性烯醇化酶(NSE)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，不得用于普通人群的肿瘤筛查。
Reagent R1: NSE antibody-coated magnetic particles, Reagent R2: acridine-labeled NSE antibody, Reagent R3: PBS buffer solution, calibrator (high, low): serum matrix with addition of NSE antigen, control (level 1, level 2): serum matrix with addition of NSE antigen. (Please refer to the product manual for details)
试剂R1：NSE抗体包被的磁颗粒，试剂R2：吖啶酯标记的NSE抗体，试剂R3：PBS缓冲溶液，校准品（高值、低值）：添加NSE抗原的血清基质，质控品（水平1、水平2）：添加NSE抗原的血清基质。（具体内容详见产品说明书）
- Appendix
- 产品技术要求
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