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China NMPA legacy archive 浙械注准20242401067

CA15-3 test kit (chemiluminescence immunoassay)

癌抗原15-3(CA15-3)检测试剂(化学发光免疫分析法)
Acon Biotech (Hangzhou) Co., Ltd.Class IINMPAApproved January 19, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
50 servings/box, 100 servings/box.
50人份/盒、100人份/盒。
Approval department
Zhejiang Provincial Drug Administration
浙江省药品监督管理局
Registration information
Registration number
浙械注准20242401067
Approval date
January 19, 2024
Expiry date
October 31, 2029
Registrant
Name
Acon Biotech (Hangzhou) Co., Ltd.
艾康生物技术(杭州)有限公司
Province/Region
Zhejiang
浙江
Address
No. 210, Zhenzhong Road, West Lake District, Hangzhou
杭州市西湖区振中路210号
Production facility
Production address
杭州市西湖区振中路210号;杭州市临安区开源街8号3幢(仓库地址)
Intended use
English

This kit is used for the in vitro quantitative detection of cancer antigen 15-3 (CA15-3) in human serum or plasma samples. This reagent 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 cannot be used for tumor screening in the general population.

中文

本试剂盒用于体外定量检测人血清或血浆样本中的癌抗原15-3(CA15-3)的含量。本试剂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,不能用于普通人群的肿瘤筛查。

Structure and composition
English

试剂1(R1),试剂2(R2),试剂M,校准品(2个水平),质控品L,质控品M,质控品H.(具体内容详见说明书)

中文

试剂1(R1),试剂2(R2),试剂M,校准品(2个水平),质控品L,质控品M,质控品H。(具体内容详见说明书)

Storage conditions and expiration
English

This product is stored at 2~8°C and is valid for 12 months.

中文

本产品于2~8℃下保存,有效期12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 CA15-3 test kit (chemiluminescence immunoassay), registration 浙械注准20242401067. 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.