Dry Biochemical Analyzer - NMPA Registration 苏械注准20232220232
Access comprehensive regulatory information for Dry Biochemical 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 苏械注准20232220232 and owned by Lansion Biotechnology Co., Ltd.. The device was approved on February 20, 2023.
This page provides complete registration details including registrant information, province location (Jiangsu), 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.
This product adopts microfluidic dry chemistry method based on ultraviolet spectrophotometry, and is used together with the supporting reagent produced by the company (liver function biochemical nine detection kits (microfluidic dry chemistry)), and is used clinically for the quantitative detection of analytes in whole blood, plasma and serum samples derived from human body, including total bilirubin, direct bilirubin, total bile acid, total protein, albumin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transferase project.
本产品采用基于紫外分光光度法的微流控干化学法，与本公司生产的配套试剂（肝功能生化九项检测试剂盒（微流控干化学法））共同使用，在临床上用于对来源于人体的全血、血浆、血清样本中的被分析物进行定量检测，包括总胆红素、直接胆红素、总胆汁酸、总蛋白、白蛋白、丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、碱性磷酸酶、γ-谷氨酰基转移酶项目。
The instrument is composed of thermal insulation module, detection module, microprocessing module, display module, printing module, barcode scanning module and external communication module.
仪器由保温模块、检测模块、微处理模块、显示模块、打印模块、条码扫描模块、外部通讯模块组成。
not applicable
不适用