Vietnam MOH registration 2403375ĐKLH/BYT-HTTB

NT-proBNP Quantitative Testing Drug

VN: Thuốc thử xét nghiệm định lượng NT-proBNP

Vietnam·Risk Class TTBYT Loại C·Elecsys proBNP II·Roche Diagnostics (Suzhou) Ltd.·Registered Nov 06, 2024

Registration details

Analysis ID: 2403375ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-221207-0024
Product Type: Elecsys proBNP II
Product Code: 09315284214

Company information

Manufacturer: Roche Diagnostics (Suzhou) Ltd.
Manufacturer Country: CHINA
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: 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

Registration Date: Nov 06, 2024

About this record

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.

This page provides complete technical specifications, regulatory compliance details. 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.