China NMPA legacy archive 国械注准20243400590Alpha-fetoprotein detection kit (fluorescence immunochromatography)
- Device class
- Class III
- Model specifications
- 1 serving/box, 3 servings/box, 5 servings/box, 10 servings/box, 25 servings/box, 50 servings/box, 100 servings/box; 1×5 servings/box, 2×5 servings/box, 3×5 servings/box, 4×5 servings/box, 1×10 servings/box, 2×10 servings/box, 3×10 servings/box, 4×10 servings/box, 1×12 servings/box, 2×12 servings/box, 3×12 servings/box, 4×12 servings/box, 1×15 servings/box, 2×15 servings/box, 3×15 servings/box, 4×15 servings/box, 1×20 servings/box, 2×20 servings/box, 3×20 servings/ Box, 4×20 servings/box, 1×24 servings/box, 2×24 servings/box, 3×24 servings/box, 4×24 servings/box, 1×30 servings/box, 2×30 servings/box, 3×30 servings/box, 4×30 portions/box, 1×40 servings/box, 2×40 person/box, 3×40 portions/box, 4×40 servings/box, 1×48 servings/box, 2×48 servings/box, 3×48 servings/box, 4×48 servings/box.
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243400590
- Approval date
- March 26, 2024
- Expiry date
- March 25, 2029
- Province/Region
- Jiangsu
- Address
- No. 9, Bofu Road, Yanjiang Industrial Development Zone, Liuhe District, Nanjing
- Production address
- 南京市六合区沿江工业开发区博富路9号；南京市江北新区科丰路6号
This kit is used for the quantitative detection of alpha-fetoprotein (AFP) content in human serum and plasma in vitro. It 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 should not be used for tumor screening in the general population.
本试剂盒用于体外定量检测人血清、血浆中甲胎蛋白（AFP）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，不宜用于普通人群的肿瘤筛查。
The kit consists of a test card, a test buffer, an SD card, and a pipette. (Please refer to the product manual for details)
试剂盒由检测卡、检测缓冲液、SD卡、吸管组成。（具体内容详见产品说明书）
The test card is stored at 4~30°C, sealed and valid for 18 months.
检测卡于4～30℃，密封状态下存放，有效期为18个月。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for Alpha-fetoprotein detection kit (fluorescence immunochromatography), registration 国械注准20243400590. It does not establish current authorization or complete current product details.
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