Vietnam MOH registration 230000722/PCBB-HCM

IVD Cluster for Infection Testing in the Biochemical Testing System

VN: Cụm IVD xét nghiệm viêm nhiễm trong hệ thống máy xét nghiệm sinh hóa

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Apr 07, 2023

Registration details

Analysis ID: 230000722/PCBB-HCM
Submission ID: 000.00.19.H29-230406-0003
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Theo theo phụ lục
Manufacturer Country: Theo theo phụ lục

Technical details

Intended Use: - Used to quantify the concentration of Immunoglobulin A in serum on various fluorescent measurement systems. - Used to quantify the concentration of Immunoglobulin E in serum on various fluorescent measurement systems. - Used to calibrate the quantitative C3, C4, CRP, IgA, IgG, IgM tests on the Mindray biochemical analyzer system - Used in the quality control of ASO, CRP and RF tests by monitoring the accuracy and precision of the Mindray biochemical analyzer system and the performance of the clinical laboratory - Used to calibrate the quantitative IgE test on the Mindray biochemical analyzer system - Used to quantify the concentration of Complement C3 in serum on various fluorescent measurement systems. - Used to quantify the concentration of Complement C4 in serum on various fluorescent measurement systems. - Used to quantify the concentration of C-Reactive Protein in serum on various fluorescent measurement systems. - Used to quantify the concentration of Low Molecular Weight Factor (RF) in serum on various fluorescent measurement systems - Used to quantify the concentration of Immunoglobulin G in serum on various fluorescent measurement systems. - Used to quantify the concentration of Immunoglobulin M in serum on various fluorescent measurement systems. - Used to quantify the concentration of Antistreptolysin "O" in serum on various fluorescent measurement systems. - Used in the quality control of Low Molecular Weight Factor (RF) tests by monitoring the accuracy and precision of the Mindray biochemical analyzer system and the performance of the clinical laboratory (Normal concentration range) - Used in the quality control of Low Molecular Weight Factor (RF) tests by monitoring the accuracy and precision of the Mindray biochemical analyzer system and the performance of the clinical laboratory (Abnormal concentration range or pathological range) - Used to calibrate the quantitative Anti-Streptolysin O (ASO) test on the Mindray biochemical analyzer system - Used to quantify the concentration of C-Reactive Protein (Extended Range) in serum on various fluorescent measurement systems. - Used to calibrate the quantitative Low Molecular Weight Factor (RF) test on the Mindray biochemical analyzer system - Used to quantify the concentration of C-Reactive Protein (High Sensitivity) in serum on various fluorescent measurement systems. - Used to calibrate the quantitative High Sensitivity C-Reaction Protein test on the Mindray biochemical analyzer system

Dates and status

Registration Date: Apr 07, 2023

About this record

Access comprehensive regulatory information for IVD Cluster for Infection Testing in the Biochemical Testing System 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 230000722/PCBB-HCM and manufactured by Theo theo phụ lục.

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