NT-proBNP Quantitative Testing Drug - Vietnam Registration 2403375ĐKLH/BYT-HTTB
Access comprehensive regulatory information for NT-proBNP Quantitative Testing Drug 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 2403375ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics (Suzhou) Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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Device Details
Registration Details
2403375ĐKLH/BYT-HTTB
000.00.04.G18-221207-0024
Elecsys proBNP II
09315284214
Technical Details
In vitro immunoassay for the quantitative determination of N-terminal pro B-type natriuretic peptide in human serum and plasma. This test is indicated to support the diagnosis of individuals suspected of having congestive heart failure and to detect mild forms of cardiac dysfunction. The test also supports the assessment of the severity of heart failure in patients diagnosed with congestive heart failure. It is indicated for risk stratification of patients with acute coronary syndrome and congestive heart failure, and it can also be used to monitor treatment in patients with left ventricular dysfunction. It can help assess the cardiovascular risk of type 2 diabetes patients. The test is also indicated to support the determination of risk in type 2 diabetes patients without a history of cardiovascular disease, to optimize cardiovascular protection therapy. It can be used to identify older individuals at high risk for atrial fibrillation. The ECLIA (electrochemiluminescence immunoassay “ECLIA”) is used for the immunoassay cobas e.
Dates and Status
Nov 06, 2024