IVD Department Quantitative NT-proBNP Testing
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Nov 06, 2024- Analysis ID
- 2403391ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-231213-0003
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- CÔNG TY TNHH ROCHE VIỆT NAM
- Intended Use
- Roche CARDIAC POC NT-proBNP: Roche CARDIACPOCNT‑proBNP is an in vitro diagnostic test designed to determine the concentration of NT-proBNP in heparinized venous blood, to be used with the cobash232 instrument. The Roche CARDIACPOCNT‑proBNP test aims to support the diagnosis of patients suspected of having heart failure, to monitor patients with compensated left ventricular dysfunction, and to stratify the risk of patients with acute coronary syndrome. This test can help assess the risk of cardiovascular disease in patients with type 2 diabetes. It is also indicated to support the determination of patients with type 2 diabetes at risk of cardiovascular disease, where the medical history of cardiovascular disease is unclear, in order to optimize the treatment strategy for cardiovascular protection. This test can be used to identify individuals at high risk of atrial fibrillation. The test is intended for use near the patient. It is not intended for self-testing. Roche CARDIAC POC NT-proBNP Control: RocheCARDIACPOCNT‑proBNP Control is used to control the quality of the Roche CARDIACPOC NT-proBNP test on the cobash232 instrument. It is a control sample used for the near-patient testing. It is not intended for self-testing.
- Registration Date
- Nov 06, 2024
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Access comprehensive regulatory information for IVD Department Quantitative NT-proBNP Testing 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 2403391ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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