Vietnam MOH registration 240001182/PCBB-HN

IVD Cluster: Other Specific Proteins: hsCRP, Presepsin, PCT

VN: Cụm IVD Các protein đặc thù khác: hsCRP, Presepsin, PCT

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

Registration details

Analysis ID: 240001182/PCBB-HN
Submission ID: 000.00.19.H26-240518-0003
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 hsCRP is a product used in in vitro diagnostic testing with the PATHFAST automated in vitro diagnostic testing (IVD) system to measure the quantitative concentration of C-reactive protein (CRP) in human serum, whole blood and heparinized or EDTA-anticoagulated blood. PATHFAST hsCRP is designed to be used: − As a diagnostic aid in the evaluation of suspected inflammatory disorders and related disorders in patients, − As a diagnostic aid in the assessment of cardiovascular risk, − As a diagnostic aid in the assessment of the risk of recurrent cardiovascular events in patients with stable coronary heart disease (CHD) and acute coronary syndrome (ACS), − By laboratory technicians, nurses, or physicians, − In hospitals, including the emergency room, the doctor's office, and the clinical laboratory. PATHFAST Presepsin is a bedside diagnostic test (NPT) PATHFAST Presepsin is a product used in in vitro diagnostic testing with the PATHFAST automated in vitro diagnostic testing (IVD) system to measure the concentration of presepsin in the serum and heparinized or EDTA-anticoagulated whole blood of people. PATHFAST Presepsin is used to: - Serve as a diagnostic aid in the diagnosis and prognosis of sepsis, - In the assessment of the severity of sepsis, - In the risk stratification of severely ill patients, - By laboratory technicians, nurses, or physicians, - In hospitals, including the emergency room, the doctor's office, and the clinical laboratory. PATHFAST Presepsin is a bedside diagnostic test (NPT) PATHFAST B･R･A･H･M･S PCT is a product used for in vitro diagnostic testing with the PATHFAST automated in vitro diagnostic testing (IVD) system to measure the quantitative concentration of Procalcitonin (PCT) in human serum, EDTA-anticoagulated whole blood and EDTA-anticoagulated blood. PATHFAST B･R･A･H･M･S PCT is used: - As a diagnostic aid in the early detection and differential diagnosis of clinically relevant bacterial infections, as a diagnostic aid in the assessment of the severity of sepsis and risk stratification of patients with sepsis, severe sepsis, and septic shock, - As a diagnostic aid in the decision-making process for antibiotic therapy in patients with lower respiratory tract infections (LRTI) and patients suspected or confirmed to have sepsis, - By laboratory technicians, nurses, or physicians, - In hospitals, including the emergency room, the doctor's office, and the clinical laboratory. PATHFAST B･R･A･H･M･S PCT is a bedside diagnostic test (NPT). PATHFAST B･R･A･H･M･S PCT Control is used to control the quality of the PATHFAST B･R･A･H･M･S PCT fluorescent immunoassay on the PATHFAST automated in vitro diagnostic testing system. PATHFAST B･R･A･H･M･S PCT Control is used by laboratory technicians, nurses, or physicians, in the clinical laboratory, including the emergency room, the doctor's office, and the clinical laboratory. PATHFAST B･R･A･H･M･S PCT Control is a bedside diagnostic test (NPT). PATHFAST Presepsin Control is used to control the quality of the PATHFAST Presepsin fluorescent immunoassay on the PATHFAST automated in vitro diagnostic testing system. PATHFAST Presepsin Control is used by laboratory technicians, nurses, or physicians, in hospitals, including the emergency room, the doctor's office, and the clinical laboratory. PATHFAST Presepsin Control is a bedside diagnostic test (NPT).

Dates and status

Registration Date: May 23, 2024

About this record

Access comprehensive regulatory information for IVD Cluster: Other Specific Proteins: hsCRP, Presepsin, PCT 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 240001182/PCBB-HN and manufactured by LSI Medience Corporation. The authorized representative in Vietnam is CÔNG TY TNHH VẠN NIÊN.

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