Fully automated specific protein analyzer - NMPA Registration 鲁械注准20232220890
Access comprehensive regulatory information for Fully automated specific protein 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 鲁械注准20232220890 and owned by Biobase Biodustry (Shandong) Co., Ltd.. The device was approved on September 17, 2023.
This page provides complete registration details including registrant information, province location (Shandong), 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.
The product adopts scattering turbidimetry method, used together with supporting detection reagents, and is clinically used to quantitatively detect specific protein components in whole blood, serum and plasma samples derived from human body, including HS-CRP project and SAA project.
该产品采用散射比浊法，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全血、血清、血浆样本中的特定蛋白成分进行定量检测，包含hs-CRP项目和SAA项目。
The degree of automation of the product is fully automatic, and the structure consists of an automatic sample injection module, a detection module, a control module and a fully automatic specific protein analyzer software.
该产品自动化程度为全自动，结构上由自动进样模块、检测模块、控制模块和全自动特定蛋白分析仪软件组成。