IVD Quantitative Hematology Testing System - Vietnam Registration 240001781/PCBA-HCM
Access comprehensive regulatory information for IVD Quantitative Hematology Testing System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại A medical device is registered under number 240001781/PCBA-HCM and manufactured by Hunan Ehome Health Technology Company Limited. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN CÔNG NGHỆ MEDIEXPRESS VIỆT NAM.
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Device Details
Registration Details
240001781/PCBA-HCM
000.00.19.H29-241030-0015
Theo theo phụ lục
Theo phụ lục
Technical Details
The hematology analyzer is used in the full blood count and white blood cell count of human blood. The sample processing unit includes a four-well sampler, a cell lysis solution for blood cell analysis, a dilution solution for blood cell analysis, and a cell counting chamber. The four-well sampler is used to collect and store human blood. The cell lysis solution for blood cell analysis is used to break down red blood cells, dissolve hemoglobin, and maintain the shape of the cells for analysis prior to blood cell analysis, to facilitate the counting of differential cells or the determination of hemoglobin concentration. The dilution solution for blood cell analysis is used to dilute the sample before blood cell analysis and to prepare the blood cell suspension. The blood cell counting chamber is used to count the formed elements in blood samples and body fluids in clinical settings
Dates and Status
Nov 18, 2024