HE4 Test Kit for Human Epididymis Protein 4 (Chemiluminescence Immunoassay Method)
- Device class
- Class II
- Model specifications
- 50 servings/box, 100 servings/box.
- Approval department
- Zhejiang Provincial Drug Administration
- Registration number
- 浙械注准20242401052
- Approval date
- January 16, 2024
- Expiry date
- October 31, 2029
- Province/Region
- Zhejiang
- Address
- No. 210, Zhenzhong Road, West Lake District, Hangzhou
- Production address
- 杭州市西湖区振中路210号;杭州市临安区开源街8号3幢(仓库地址)
This kit is used for in vitro quantitative detection of epididymal protein 4 (HE4) antigen in human serum or plasma samples. This reagent 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.
本试剂盒用于体外定量检测人血清或血浆样本中的附睾蛋白4(HE4)抗原的含量。本试剂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。
Reagent 1 (R1), Reagent 2 (R2), Reagent M, Calibrator (2 levels), Control L, Control M, Control H. (Please refer to the manual for details)
试剂1(R1),试剂2(R2),试剂M,校准品(2个水平),质控品L,质控品M,质控品H。(具体详见说明书)
This product is stored at 2~8°C and is valid for 12 months.
本产品于2~8℃下保存,有效期12个月。
- Appendix
- 产品技术要求、说明书
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