IVD Hematology Testing System
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Zybio Inc.·Registered Jun 25, 2024- Analysis ID
- 240001493/PCBB-HN
- Submission ID
- 000.00.19.H26-240620-0008
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Zybio Inc.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Zybio Inc.
- Authorized Representative
- CÔNG TY TNHH KHOA HỌC P N D
- Intended Use
- Hematology Analyzer (Types: EXZ 6000, EXZ 6010, EXZ 6020) is an automated quantitative device used in in vitro diagnosis in clinical laboratories. The device is used to provide the number of red blood cells (RBC), the number of white blood cells (WBC), the number of platelets, the concentration of Hemoglobin and to differentiate the five types of white blood cells in whole blood samples. Diluent (Label Name: Diluent Z5 DN): The product is used to dilute the sample and prepare the blood cell suspension before the blood cell analysis. Lyse (Label Name: Lyse Z5 LB): The Lyse Z5 LB solution is used to break the red blood cell membrane, release hemoglobin before the blood cell analysis. At the same time, the Lyse Z5 LB solution can cause the white blood cells to shrink, except for the basophilic granulocytes which retain their original size. The Hematology Analyzer determines the concentration of hemoglobin, differentiates the basophilic granulocytes and counts the total number of white blood cells by differentiating the differences in morphology, including cell volume and complexity of the cells. Lyse (Label Name: Lyse H56 LD-I): The Lyse H56 LD-I solution is used in combination with Lyse H56 LD-II to break the red blood cells and maintain the natural morphology of the white blood cells. The Hematology Analyzer differentiates the four types of white blood cells by differentiating the differences in morphology, including the density of the cell granules, the cell volume and the complexity of the cells. Lyse (Label Name: Lyse H56 LD-II): The Lyse H56 LD-II solution is used in combination with Lyse H56 LD-I to break the red blood cells and maintain the natural morphology of the white blood cells. The Hematology Analyzer differentiates the four types of white blood cells by differentiating the differences in morphology, including the density of the cell granules, the cell volume and the complexity of the cells. Hematology Calibrator (Label Name: Hematology Calibrator CAL): The product is used to calibrate and confirm the calibration of the WBC (white blood cell count), RBC (red blood cell count), HGB (hemoglobin concentration), HCT (hematocrit), MCV (mean corpuscular volume), and PLT (platelet count) tests. Hematology Control (Label Name: Hematology Control H5 CHECK): The product is a control material from the fully tested whole blood, used to monitor the values on the Hematology Analyzers. Probe Cleanser: The product is used to clean the detection area and the flow path of the system.
- Registration Date
- Jun 25, 2024
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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 240001493/PCBB-HN and manufactured by Zybio Inc.. The authorized representative in Vietnam is CÔNG TY TNHH KHOA HỌC P N D.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Zybio Inc., Theo theo phụ lục, 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.