Automatic Blood Coagulation Analyzer
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Sysmex Corporation·Registered Nov 14, 2024- Analysis ID
- 2403576ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-210202-0011
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Sysmex Corporation
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Sysmex Corporation
- Authorized Representative
- CÔNG TY TNHH SYSMEX VIỆT NAM
- Intended Use
- The Sysmex CS-2400/CS-2500 is a fully automated blood coagulation test device designed for in-vitro diagnostic use to assess blood clotting parameters by point-of-care, colorimetric, immunoassay and precipitation methods. The primary sample for analysis is the blood plasma with an added blood clotting inhibitor (sodium citrate). However, if a sample for analysis is designated to contain a test drug, follow the instructions for that drug. This device is not intended for any other purpose. Only the reagents and cleaning solutions specified in this manual are permitted for use. The conditions of use also apply to compliance with the cleaning and maintenance procedures described in this manual.
- Registration Date
- Nov 14, 2024
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Access comprehensive regulatory information for Automatic Blood Coagulation Analyzer in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403576ĐKLH/BYT-HTTB and manufactured by Sysmex Corporation. The authorized representative in Vietnam is CÔNG TY TNHH SYSMEX VIỆT NAM.
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