Cardiovascular Biomarker Cluster: CK-MB, hs-cTnI, Myoglobin, NTproBNP - Vietnam Registration 240001183/PCBB-HN

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