Blood cell analyzer - NMPA Registration 鲁械注准20232220455
Access comprehensive regulatory information for Blood cell 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20232220455 and owned by Biobase Biodustry (Shandong) Co., Ltd.. The device was approved on June 16, 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 hematology analyzer is used in combination with the hemolytic agent for the SFL hematology analyzer produced by our company and the dilution for SFL-1 blood cell analysis, and the blood samples from the human body are quantified and the leukocyte triangular group is quantified and analyzed by the electrical impedance method (Coulter's principle) and colorimetric method in clinical practice, and is used to measure the number of white blood cells (WBC), lymphocytes (Lym#), intermediate cells (Mid#), neutrophils (Gran#), lymphocyte percentage (Lym%), Percentage of Intermediate Cells (Mid%), Percentage of Neutrophils (Gran Percentage), Number of Erythrocytes (RBC), Hemoglobin Concentration (HGB), Hematocrit (HCT), Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin Content (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Erythrocyte Volume Distribution Width-Coefficient of Variation (RDW-CV), Erythrocyte Volume Distribution Width-Standard Deviation (RDW-SD), Platelet number (PLT), mean platelet volume (MPV), platelet volume distribution width-coefficient of variation (PDW-CV), platelet volume distribution width-standard deviation (PDW-SD), platelet hematocrit (PCT) and large platelet ratio (P-LCR) were tested, and histogram information of white blood cells, red blood cells, and platelets was provided.
血细胞分析仪与我司生产的SFL血细胞分析仪用溶血剂和SFL-1血细胞分析用稀释液联合使用，通过电阻抗法（库尔特原理）和比色法在临床上对来源于人体的血液样本进行定量分析和白细胞三分群，用于对白细胞数目（WBC）、淋巴细胞数目（Lym#）、中间细胞数目（Mid#）、中性粒细胞数目（Gran#）、淋巴细胞百分比（Lym百分比）、中间细胞百分比（Mid百分比）、中性粒细胞百分比（Gran百分比）、红细胞数目（RBC）、血红蛋白浓度（HGB）、红细胞压积（HCT）、平均红细胞体积（MCV）、平均红细胞血红蛋白含量（MCH）、平均红细胞血红蛋白浓度（MCHC）、红细胞体积分布宽度-变异系数（RDW-CV）、红细胞体积分布宽度-标准差（RDW-SD）、血小板数目（PLT）、平均血小板体积（MPV）、血小板体积分布宽度-变异系数（PDW-CV）、血小板体积分布宽度-标准差（PDW-SD）、血小板压积（PCT）和大血小板比率（P-LCR）的检验，并提供白细胞、红细胞、血小板的直方图信息。
It is composed of a blood cell detection module, a hemoglobin measurement module, a mechanical module, an electronic module and a computer system (software release version V01).
由血细胞检测模块、血红蛋白测定模块、机械模块、电子模块和计算机系统（软件发布版本V01）等组成。