Vietnam MOH registration 240001183/PCBB-HN

Cardiovascular Biomarker Cluster: CK-MB, hs-cTnI, Myoglobin, NTproBNP

VN: Cụm IVD dấu ấn tim mạch: CK-MB, hs-cTnI, Myoglobin, NTproBNP

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·LSI Medience Corporation·Registered May 23, 2024

Registration details

Analysis ID: 240001183/PCBB-HN
Submission ID: 000.00.19.H26-240519-0003
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: LSI Medience Corporation
Manufacturer Country: Theo theo phụ lục
Product Owner: LSI Medience Corporation
Authorized Representative: CÔNG TY TNHH VẠN NIÊN

Technical details

Intended Use: PATHFAST CK-MB is a product used for diagnosis in the laboratory with the PATHFAST in vitro diagnostic automated analysis machine (IVD) to measure the concentration of Creatinekinase isozyme MB (CK-MB) in blood and whole blood with heparin or EDTA. PATHFAST CK-MB is designed to be used: - to support the diagnosis of acute myocardial infarction (AMI), - by laboratory technicians, nurses, or doctors, - in hospitals including the emergency room, doctor's office, and clinical laboratory. PATHFAST CK-MB is a point-of-care (POC) diagnostic device PATHFAST hs-cTnI is a product used for diagnosis in the laboratory with the PATHFAST in vitro diagnostic automated analysis machine (IVD) to measure the concentration of cardiac troponin I (hs-cTnI) in blood and whole blood with heparin or EDTA. PATHFAST hs-cTnI is designed to be used: - to stratify risk in patients suspected of having ACS, - by laboratory technicians, nurses, or doctors, - in hospitals including the emergency room, doctor's office, and clinical laboratory. PATHFAST hs-cTnI is a point-of-care (POC) diagnostic device PATHFAST Myo is a product used for diagnosis in the laboratory with the PATHFAST in vitro diagnostic automated analysis machine (IVD) to measure the concentration of Myoglobin (Myo) in blood and whole blood of people in heparin or EDTA tubes. PATHFAST Myo is used in the following cases: - to support diagnosis and particularly to rule out acute myocardial infarction (AMI), - by laboratory technicians, nurses, or doctors, - in hospitals including the emergency room, doctor's office, and clinical laboratory. PATHFAST Myo is a point-of-care (POC) diagnostic device PATHFAST NTproBNP is a product used for in-vitro diagnosis with the PATHFAST in vitro diagnostic automated analysis machine (IVD) to measure the concentration of the pro-BNP peptide (NT-proBNP) in blood with heparin or EDTA. PATHFAST NTproBNP is designed to be used: - as a support in diagnosis in patients suspected of having heart failure (CHF) and to detect left ventricular dysfunction, - as a support in assessing the severity of CHF, - to stratify risk in patients with acute coronary syndrome (ACS) and CHF, - to monitor treatment in patients with left ventricular dysfunction, - by laboratory technicians, nurses, or doctors, - in hospitals including the emergency room, doctor's office, and clinical laboratory. PATHFAST NTproBNP is a point-of-care (POC) diagnostic device

Dates and status

Registration Date: May 23, 2024

About this record

Access comprehensive regulatory information for Cardiovascular Biomarker Cluster: CK-MB, hs-cTnI, Myoglobin, NTproBNP 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 240001183/PCBB-HN and manufactured by LSI Medience Corporation. The authorized representative in Vietnam is CÔNG TY TNHH VẠN NIÊN.

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