IVD Cluster – Chemicals for Hematology Analysis Machines - Vietnam Registration 240002905/PCBB-HN
Access comprehensive regulatory information for IVD Cluster – Chemicals for Hematology Analysis Machines in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002905/PCBB-HN and manufactured by Shenzhen Dymind Biotechnology Co., Ltd. The authorized representative in Vietnam is CÔNG TY TNHH CTMED VIỆT NAM.
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Device Details
Registration Details
240002905/PCBB-HN
000.00.19.H26-241024-0034
Theo theo phụ lục
Theo phụ lục
Technical Details
Used to lyse (break down) red blood cells to determine hemoglobin or to support the count of white blood cells. The hematology control is used to control the quality of the parameters including WBC, RBC, HGB, MCV/HCT and PLT of the hematology analyzer produced by the Shenzhen Dymind Biotech Co., Ltd. The purpose of the quality control is to monitor the accuracy and precision of the test results. The hematology calibration kit is used to calibrate the parameters including WBC, RBC, HGB, MCV/HCT and PLT of the hematology analyzer produced by the Shenzhen Dymind Biotech Co., Ltd., thereby establishing the traceability of the measurement results of the hematology analyzer. To determine the concentration of C-reactive protein in human serum or whole blood in vitro. This product is used to control the quality of C-reactive protein and the highly sensitive protein products of the current detection system. This product is used to control the quality of C-reactive protein and the highly sensitive protein products of the current detection system. Used to break down the red blood cell membrane and convert hemoglobin into the hemoglobin complex to determine HGB. and to maintain the morphology of the cells required for blood cell analysis, thus facilitating the classification and counting of cells.
Dates and Status
Oct 28, 2024

