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IVD Enzymes Cluster: ALP, ALT, Amylase, AST, GGT, Lipase, LDH, CK - Vietnam Registration 230000011/PCBB-BD

Access comprehensive regulatory information for IVD Enzymes Cluster: ALP, ALT, Amylase, AST, GGT, Lipase, LDH, CK 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 230000011/PCBB-BD and manufactured by Theo theo phụ lục.

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Registration Details
Vietnam MOH Registration: 230000011/PCBB-BD
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Device Details

IVD Enzymes Cluster: ALP, ALT, Amylase, AST, GGT, Lipase, LDH, CK
VN: Cụm IVD Enzymes: ALP, ALT, Amylase, AST, GGT, Lipase, LDH, CK
Risk Class TTBYT Loại B

Registration Details

230000011/PCBB-BD

000.00.17.H09-230401-0002

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Technical Details

-ABX Pentra ALP CP: ABX Pentra ALP CP is a diagnostic reagent used for the quantitative in vitro determination of alkaline phosphatase in human serum and plasma, based on the kinetic fluorescence assay using p-Nitrophenylphosphate. The measurement of alkaline phosphatase or its isoenzymes is used in the diagnosis and treatment of liver, bone, kidney, and bowel disorders; -ABX Pentra ALT CP: ABX Pentra ALT CP is a diagnostic reagent used for the quantitative in vitro determination of Alanine AminoTransferase (ALT) in human serum and plasma by colorimetric assay. The measurement of Alanine amino transferase is used in the diagnosis and treatment of various liver disorders (such as viral hepatitis and cirrhosis) and heart disorders; -ABX Pentra Amylase CP: ABX Pentra Amylase CP is a diagnostic reagent used for the quantitative in vitro determination of the activity of amylase in human serum, plasma, and urine by the kinetic fluorescence assay. The measurement of amylase is primarily used in the diagnosis and treatment of pancreatitis (pancreatic inflammation); -ABX Pentra AST CP: ABX Pentra AST CP is a diagnostic reagent used for the quantitative in vitro determination of aspartate aminotransferase in human serum and plasma, based on the UV assay using L-aspartate and 2-oxoglutarate. The measurement of aspartate aminotransferase is used in the diagnosis and treatment of various liver and heart disorders; -ABX Pentra GGT CP: ABX Pentra GGT CP is a diagnostic reagent used for the quantitative in vitro determination of Gamma-GlutamylTransferase (GGT) in human serum or plasma. The measurement of gamma-glutamyltranspeptidase is used in the diagnosis and treatment of liver disorders such as alcohol-induced cirrhosis and primary or secondary liver cancer; -ABX Pentra Lipase CP: ABX Pentra Lipase CP is a diagnostic reagent used for the quantitative in vitro determination of lipase in human serum and plasma. The measurement of lipase is used in the diagnosis and treatment of pancreatic disorders such as acute pancreatitis and pancreatic duct obstruction; -ABX Pentra CK NAC CP: ABX Pentra CK NAC CP is a diagnostic reagent used for the quantitative in vitro determination of total creatine kinase in human serum or plasma by an optimized UV assay. The measurement of creatine phosphokinase and its isoenzymes is used in the diagnosis and treatment of myocardial infarction and various muscle disorders, including the progressive Duchenne muscular dystrophy; -ABX Pentra LDH CP: ABX Pentra LDH CP is a diagnostic reagent used for the quantitative in vitro determination of Lactate Dehydrogenase (LDH) in human serum or plasma. The measurement of lactate dehydrogenase is used in the diagnosis and treatment of liver disorders such as acute viral hepatitis and cirrhosis, and metastatic liver cancer, as well as heart disorders such as myocardial infarction, and lung and kidney tumors; -ABX Pentra LDH IFCC CP: ABX Pentra LDH IFCC CP is a diagnostic reagent used for the quantitative in vitro determination of Lactate Dehydrogenase (LDH) in human serum or plasma. The measurement of lactate dehydrogenase is used in the diagnosis and treatment of liver disorders such as acute viral hepatitis and cirrhosis, and metastatic liver cancer, as well as heart disorders such as myocardial infarction, and lung and kidney tumors

Dates and Status

Apr 05, 2023