Vietnam MOH registration 240002905/PCBB-HN

IVD Cluster – Chemicals for Hematology Analysis Machines

VN: Cụm IVD – Hóa chất dùng cho máy phân tích huyết học

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Shenzhen Dymind Biotechnology Co., Ltd·Registered Oct 28, 2024

Registration details

Analysis ID: 240002905/PCBB-HN
Submission ID: 000.00.19.H26-241024-0034
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd
Manufacturer Country: Theo theo phụ lục
Product Owner: Shenzhen Dymind Biotechnology Co., Ltd
Authorized Representative: CÔNG TY TNHH CTMED VIỆT NAM

Technical details

Intended Use: 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

Registration Date: Oct 28, 2024

About this record

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.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.