Fully automatic chemiluminescence immunoassay analyzer - NMPA Registration 京械注准20232220439
Access comprehensive regulatory information for Fully automatic chemiluminescence immunoassay analyzer in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20232220439 and owned by Beijing Leadman Biochemistry Co., Ltd.. The device was approved on July 03, 2023.
This page provides complete registration details including registrant information, province location (Beijing), 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.
Used in conjunction with adaptations for qualitative or quantitative analysis of analytes in human samples.
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。
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).
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。
10 years
10年