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China NMPA legacy archive 京械注准20232220439

Fully automatic chemiluminescence immunoassay analyzer

全自动化学发光免疫分析仪
Beijing Leadman Biochemistry Co., Ltd.Class IINMPAApproved July 03, 2023
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
CI1200 P
Approval department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration information
Registration number
京械注准20232220439
Approval date
July 03, 2023
Expiry date
July 02, 2028
Registrant
Name
Beijing Leadman Biochemistry Co., Ltd.
北京利德曼生化股份有限公司
Province/Region
Beijing
北京
Address
No. 5 Xinghai Road, Beijing Economic and Technological Development Zone, Beijing
北京市北京经济技术开发区兴海路5号
Production facility
Production address
北京市北京经济技术开发区兴海路5号1幢2层、6层、B1层、2幢
Intended use
English

Used in conjunction with adaptations for qualitative or quantitative analysis of analytes in human samples.

中文

与适配试剂配合使用,用于人体样本中待测物的定性或定量分析。

Structure and composition
English

It is mainly composed of host (including dosing module, automatic tube inlet and outlet module, reagent equipment module, incubation reaction detection module, cleaning and separation module, liquid path module, circuit control module), accessories (monitor stand (optional), power cord, serial port line, sample holder, reagent rack, liquid path tube, cleaning liquid barrel), software (release version: 1).

中文

主要由主机(包含加样模块、自动进出管模块、试剂配备模块、温育反应检测模块、清洗分离模块、液路模块、电路控制模块)、附件(显示器支架(选配)、电源线、串口线、样本架、试剂架、液路管、清洗液桶)、软件(发布版本:1)组成。

Storage conditions and expiration
English

10 years

中文

10年

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 京械注准20232220439. 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.