IVD Hematology Testing System - Vietnam Registration 230000113/PCBB-BYT
Access comprehensive regulatory information for IVD Hematology Testing System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 230000113/PCBB-BYT and manufactured by Theo theo phụ lục.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Zybio Inc., and 2 recent registrations in the same category. 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.
Device Details
Registration Details
230000113/PCBB-BYT
000.00.04.G18-230202-0004
Theo theo phụ lục
Theo phụ lục
Technical Details
1. BC-6200: The BC-6200 is an automated quantitative hematology analyzer, designed for In Vitro diagnostic analysis in clinical laboratories; it comprehensively calculates the number of blood cells, measures the concentration of Hemoglobin, the number of Reticulocytes and the concentration of Nucleated Red Blood Cells (NRBC) in blood samples, as well as the analysis of body fluids. 2. M-6FN Dye: This product is used to stain the NRBC together with M-6LN LYSE. It participates in the measurement of parameters related to NRBC by using the technology of SF cell analysis (3D analysis using information from the laser light scattering at two angles and the fluorescence signal). 3. M-6LN Lyse: This product participates in the measurement of parameters related to NRBC together with M-6FN DYE.
Dates and Status
Feb 02, 2023