IVD Hematology Testing System
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Feb 02, 2023- Analysis ID
- 230000113/PCBB-BYT
- Submission ID
- 000.00.04.G18-230202-0004
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Theo theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Intended Use
- 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.
- Registration Date
- Feb 02, 2023
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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.
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