China NMPA legacy archive 国械注准20243402369Alpha-Fetoprotein Test Kit (Chemiluminescence Immunoassay Method)
- Device class
- Class III
- Model specifications
- 30 servings/box, 50 servings/box, 100 servings/box
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243402369
- Approval date
- November 21, 2024
- Expiry date
- November 20, 2029
- Province/Region
- Guangxi
- Address
- No. D-07, Information Industrial Park, Guilin High-tech Zone
- Production address
- 桂林市高新区信息产业园D-07号
本产品用于体外定量检测人血清或血浆中甲胎蛋白(AFP)的浓度.临床上主要用于肝癌患者的治疗监测,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,不用于普通人群的肿瘤筛查.
本产品用于体外定量检测人血清或血浆中甲胎蛋白（AFP）的浓度。临床上主要用于肝癌患者的治疗监测，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，不用于普通人群的肿瘤筛查。
磁微粒:甲胎蛋白抗体偶联的磁微粒,酶标试剂:碱性磷酸酶标记的甲胎蛋白抗体,校准品,质控品.(具体内容详见产品说明书)
磁微粒：甲胎蛋白抗体偶联的磁微粒，酶标试剂：碱性磷酸酶标记的甲胎蛋白抗体，校准品，质控品。（具体内容详见产品说明书）
2℃～8℃密封保存,有效期15个月.
2℃～8℃密封保存，有效期15个月。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for Alpha-Fetoprotein Test Kit (Chemiluminescence Immunoassay Method), registration 国械注准20243402369. 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.