Vietnam MOH registration 240001073/PCBB-HN

IVD Department quantitative test for N-terminal pro Brain Natriuretic Peptide (NT-proBNP)

VN: Bộ IVD xét nghiệm định lượng N-terminal pro Brain Natriuretic Peptide (NT-proBNP)

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Ortho-Clinical Diagnostics·Registered May 13, 2024

Registration details

Analysis ID: 240001073/PCBB-HN
Submission ID: 000.00.19.H26-240507-0007
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Ortho-Clinical Diagnostics
Manufacturer Country: Theo theo phụ lục
Product Owner: Ortho-Clinical Diagnostics
Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM

Technical details

Intended Use: The intended use of the IVD quantitative N-terminal pro Brain Natriuretic Peptide (NT-proBNP) test kit is as follows: (1) The quantitative N-terminal pro Brain Natriuretic Peptide (NT-proBNP) test reagent pack (VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack): For in vitro diagnostic use to quantitate N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) on the VITROS ECi/ECiQ/3600 and VITROS 5600/XT 7600 Immunoassay Systems to aid in the diagnosis of heart failure and risk stratification of patients with acute coronary syndrome and heart failure. The test is also indicated to aid in the assessment of the risk of cardiovascular events and death in patients with stable coronary artery disease. The test may also be used to assess the severity of heart failure in patients diagnosed with heart failure. The test is also indicated to aid in the assessment of the risk of cardiovascular events and death in patients with stable coronary artery disease. The test may also be used to assess the severity of heart failure in patients diagnosed with heart failure. (2) The quantitative N-terminal pro Brain Natriuretic Peptide (NT-proBNP) calibrator (VITROS Immunodiagnostic Products NT-proBNP II Calibrator): For in vitro diagnostic use to calibrate the VITROS ECi/ECiQ/3600 and VITROS 5600/XT 7600 Immunoassay Systems when quantitating N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin). (3) The quantitative N-terminal pro Brain Natriuretic Peptide (NT-proBNP) controls (VITROS Immunodiagnostic Products NT-proBNP II Controls): For in vitro diagnostic use to monitor the performance of the VITROS ECi/ECiQ/3600 and VITROS 5600/XT 7600 Immunoassay Systems when quantitating N-terminal pro Brain Natriuretic Peptide (NT-proBNP).

Dates and status

Registration Date: May 13, 2024

About this record

Access comprehensive regulatory information for IVD Department quantitative test for N-terminal pro Brain Natriuretic Peptide (NT-proBNP) 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 240001073/PCBB-HN and manufactured by Ortho-Clinical Diagnostics. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.

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