Abnormal prothrombin assay kit (chemiluminescence)
- Device class
- Class III
- Model specifications
- 见附件.包装规格
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243402143
- Approval date
- October 28, 2024
- Expiry date
- October 27, 2029
- Name
- Sichuan Orienter Biotechnology Co., Ltd.四川沃文特生物技术有限公司
- Province/Region
- Sichuan四川
- Address
- No. 9, Kangqiang 4th Road, Chengdu High-tech Zone成都高新区康强四路9号
- Production address
- 成都高新区康强四路9 号W2、W7
This product is used for the quantitative detection of abnormal prothrombin content in human serum in vitro. It is mainly used for dynamic monitoring of liver cancer patients 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 is not used for tumor screening in the general population.
本产品用于体外定量检测人血清中异常凝血酶原的含量。主要用于对肝癌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，不用于普通人群的肿瘤筛查。
试剂1(R1):免疫磁珠;试剂2(R2):酶结合物;试剂3(R3):分析缓冲液;PIVKAⅡ校准品(冻干)和PIVKAⅡ质控品(冻干,2水平).(具体内容详见说明书)
试剂1（R1）：免疫磁珠；试剂2（R2）：酶结合物；试剂3（R3）：分析缓冲液；PIVKAⅡ校准品（冻干）和PIVKAⅡ质控品（冻干，2水平）。（具体内容详见说明书）
试剂盒于2～8℃密闭避光保存,有效期为15个月.
试剂盒于2～8℃密闭避光保存，有效期为15个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Abnormal prothrombin assay kit (chemiluminescence) 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20243402143 and owned by Sichuan Orienter Biotechnology Co., Ltd.. The device was approved on October 28, 2024.
This page provides complete registration details including registrant information, province location (Sichuan), 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.