China NMPA legacy archive 国械注准20243402400异常凝血酶原检测试剂盒(化学发光免疫分析法)
- Device class
- Class III
- Model specifications
- 10 servings/box, 2×10 servings/box, 3×10 servings/box, 4×10 servings/box, 25 servings/box, 2×25 servings/box, 3×25 servings/box, 4×25 servings/box, 50 servings/box, 2×50 servings/box, 3×50 servings/box, 4×50 servings/box, 75 servings/box, 2×75 servings/box, 3×75 servings/box, 100 servings/box, 2×100 servings/box, 150 persons/box, 200 servings/box.
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243402400
- Approval date
- November 27, 2024
- Expiry date
- November 26, 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
本试剂盒用于体外定量检测人血清、血浆中异常凝血酶原(PIVKA Ⅱ)的浓度.主要用于对已确诊肝癌患者进行动态监测以辅助判断疾病进展或治疗效果,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.
本试剂盒用于体外定量检测人血清、血浆中异常凝血酶原（PIVKA Ⅱ）的浓度。主要用于对已确诊肝癌患者进行动态监测以辅助判断疾病进展或治疗效果，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。
链亲和素包被的磁性微粒,校准品L,校准品H,吖啶酯标记的异常凝血酶原单克隆小鼠抗体,生物素标记的异常凝血酶原单克隆小鼠抗体.(具体内容详见产品说明书)
链亲和素包被的磁性微粒，校准品L，校准品H，吖啶酯标记的异常凝血酶原单克隆小鼠抗体，生物素标记的异常凝血酶原单克隆小鼠抗体。（具体内容详见产品说明书）
未开瓶试剂2~8℃保存,有效期为12个月.
未开瓶试剂2~8℃保存，有效期为12个月。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for 异常凝血酶原检测试剂盒(化学发光免疫分析法), registration 国械注准20243402400. It does not establish current authorization or complete current product details.
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