5. Classification of blood cell analyzers - NMPA Registration 鲁械注准20232220518
Access comprehensive regulatory information for 5. Classification of blood cell analyzers 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20232220518 and owned by Biobase Biodustry (Shandong) Co., Ltd.. The device was approved on June 26, 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 five-part hematology analyzer is used in combination with the supporting reagents produced by our company to quantify and analyze blood samples from the human body in clinical practice by electrical impedance method (Coulter's principle), colorimetric method and semiconductor laser flow cytometry technology, and is used to quantify the number of white blood cells (WBC), the number of red blood cells (RBC), the concentration of hemoglobin (HGB), the number of platelets (PLT), the percentage of neutrophils (NEU), the percentage of lymphocytes (LYM), Percentage of monocytes (% MON), Percentage of eosinophils (% EOS), Percentage of basophils (% BAS), Number of neutrophils (NEU#), Number of lymphocytes (LYM#), Number of monocytes (MON#), Number of eosinophils (EOS#), Number of basophils (BAS#), Mean corpuscular hemoglobin concentration (MCHC), Mean corpuscular hemoglobin content (MCH), The mean corpuscular volume (MCV), erythrocyte distribution width-coefficient of variation (RDW-CV), erythrocyte distribution width-standard deviation (RDW-SD), hematocrit (HCT), mean platelet volume (MPV), platelet distribution width (PDW), platelet hematocrit (PCT), large platelet count (P-LCC) and large platelet ratio (P-LCR) were tested, and histograms of leukocytes, erythrocytes, platelets and white blood cells with five differential scatterplots were provided.
五分类血细胞分析仪与我司生产的配套试剂联合使用，通过电阻抗法（库尔特原理）、比色法和半导体激光流式细胞技术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五分类，用于对白细胞数目（WBC）、红细胞数目（RBC）、血红蛋白浓度（HGB）、血小板数目（PLT）、中性粒细胞百分比（NEU百分比）、淋巴细胞百分比（LYM百分比）、单核细胞百分比（MON百分比）、嗜酸性粒细胞百分比（EOS百分比）、嗜碱性粒细胞百分比（BAS百分比）、中性粒细胞数目（NEU#）、淋巴细胞数目（LYM#）、单核细胞数目（MON#）、嗜酸性粒细胞数目（EOS#）、嗜碱性粒细胞数目（BAS#）、平均红细胞血红蛋白浓度（MCHC）、平均红细胞血红蛋白含量（MCH）、平均红细胞体积（MCV）、红细胞分布宽度-变异系数（RDW-CV）、红细胞分布宽度-标准差（（RDW-SD）、红细胞压积（HCT）、平均血小板体积（MPV）、血小板分布宽度（PDW）、血小板压积（PCT）、大血小板数目（P-LCC）和大血小板比率（P-LCR）的检验，并提供白细胞、红细胞、血小板的直方图和白细胞五分类散点图信息。
The product structure is composed of a hematology cell detection module, a hemoglobin determination module, an incubation module, a leukocyte differential counting module, a mechanical module, an electronic module and a computer system (software release version V1).
产品结构上由血细胞检测模块、血红蛋白测定模块、孵育模块、白细胞五分类计数模块、机械模块、电子模块和计算机系统（软件发布版本V1）组成。