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China NMPA legacy archive 鄂械注准20242225041

Fully automatic chemiluminescence immunoassay analyzer

全自动化学发光免疫分析仪
Wuhan Life Origin Biotech Joint Stock Co., Ltd.Class IINMPAApproved June 27, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
SZY-CL8000、SZY-CL8100
Approval department
Hubei Provincial Drug Administration
湖北省药品监督管理局
Registration information
Registration number
鄂械注准20242225041
Approval date
June 27, 2024
Expiry date
June 26, 2029
Registrant
Name
Wuhan Life Origin Biotech Joint Stock Co., Ltd.
武汉生之源生物科技股份有限公司
Province/Region
Hubei
湖北
Address
1st, 2nd and 3rd floor, No. 818 Gaoxin Avenue, Wuhan East Lake New Technology Development Zone, No. 818 High-tech Medical Equipment Park
武汉东湖新技术开发区高新大道818号高科医疗器械园B11号1楼、2楼、3楼
Production facility
Production address
武汉东湖新技术开发区高新大道818号高科医疗器械园B11号3楼
Intended use
English

The indirect chemiluminescence method based on AMPPD and alkaline phosphatase, together with supporting detection reagents, is used in clinical practice for the qualitative or quantitative detection of analytes in serum and plasma samples derived from humans, including hormones, autoantibodies, proteins and peptides, myocardial markers, tumor markers, and infectious diseases.

中文

采用基于AMPPD和碱性磷酸酶的间接化学发光法,与配套的检测试剂共同使用,在临床上用于对来源于人体的血清和血浆样本中的被分析物进行定性或者定量检测,包括激素、自身抗体、蛋白质及多肽、心肌标志物、肿瘤标志物、感染性疾病的相关项目。

Structure and composition
English

The automatic chemiluminescence immunoassay analyzer consists of a sample scheduling module, an analysis module, a control module, accessories and consumables. The analysis module is composed of a sample rack conveying track, a reagent processing system, a reaction cup transfer system, a sample reagent dispensing system, a reaction solution mixing system, a magnetic separation system, a substrate system, a photometry and reaction system. The control module consists of a capacitive touch all-in-one machine, a barcode scanner, and a fully automated chemiluminescence immunoassay analyzer software (embedded control software component, version: V1).

中文

全自动化学发光免疫分析仪由样本调度模块、分析模块、控制模块、附件及耗材组成。其中分析模块由样本架输送轨道、试剂处理系统、反应杯转运系统、样本试剂分注系统、反应液混匀系统、磁分离系统、底物系统、光测及反应系统组成;控制模块由电容触控一体机、条码扫描仪、全自动化学发光免疫分析仪软件(嵌入式控制型软件组件,版本:V1)组成。

Additional information
Appendix
产品技术要求
About this record

This static archive preserves historical registration fields and translations for Fully automatic chemiluminescence immunoassay analyzer, registration 鄂械注准20242225041. 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.