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China NMPA legacy archive 国械注准20243402143

Abnormal prothrombin assay kit (chemiluminescence)

异常凝血酶原测定试剂盒(化学发光法)
Sichuan Orienter Biotechnology Co., Ltd.Class IIINMPAApproved October 28, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
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 information
Registration number
国械注准20243402143
Approval date
October 28, 2024
Expiry date
October 27, 2029
Registrant
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 facility
Production address
成都高新区康强四路9 号W2、W7
Intended use
English

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.

中文

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。

Structure and composition
English

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)

中文

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)

Storage conditions and expiration
English

试剂盒于2~8℃密闭避光保存,有效期为15个月.

中文

试剂盒于2~8℃密闭避光保存,有效期为15个月。

Additional information
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for Abnormal prothrombin assay kit (chemiluminescence), registration 国械注准20243402143. 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.