异常凝血酶原(PIVKA-Ⅱ)检测试剂盒(化学发光免疫分析法)
- Device class
- Class III
- Model specifications
- 50测试/盒、100测试/盒(2×50测试)、100测试/盒(1×100测试)、200测试/盒、400测试/盒50测试/盒、100测试/盒（2×50测试）、100测试/盒（1×100测试）、200测试/盒、400测试/盒
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243402495
- Approval date
- December 13, 2024
- Expiry date
- December 12, 2029
- Name
- Medicalsystem Biotechnology Co., Ltd.美康生物科技股份有限公司
- Province/Region
- Zhejiang浙江
- Address
- No. 299, Qiming South Road, Yinzhou District, Ningbo宁波市鄞州区启明南路299号
- Production address
- 宁波市鄞州区启明南路299号 、宁波市鄞州区下应街道金达南路 1228号
本试剂盒用于体外定量检测人血清中异常凝血酶原(PIVKA-Ⅱ)的含量.用于对已确诊的肝癌患者进行动态监测以辅助诊断疾病的进展或治疗效果,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中异常凝血酶原（PIVKA-Ⅱ）的含量。用于对已确诊的肝癌患者进行动态监测以辅助诊断疾病的进展或治疗效果，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。
标记试剂、固相试剂、辅助试剂、校准品1~校准品6、质控品1和质控品2.(具体内容详见产品说明书)
标记试剂、固相试剂、辅助试剂、校准品1~校准品6、质控品1和质控品2。（具体内容详见产品说明书）
Store at 2~8°C, valid for 12 months.
2～8℃保存，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for 异常凝血酶原(PIVKA-Ⅱ)检测试剂盒(化学发光免疫分析法) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243402495 and owned by Medicalsystem Biotechnology Co., Ltd.. The device was approved on December 13, 2024.
This page provides complete registration details including registrant information, province location (Zhejiang), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.