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Quantitative Total Bilirubin Test Reagent - Vietnam Registration 240000593/PCBB-HN

Access comprehensive regulatory information for Quantitative Total Bilirubin Test Reagent 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 240000593/PCBB-HN. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Abbott Ireland Diagnostics Division, Fortress Diagnostics, and 2 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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Registration Details
Vietnam MOH Registration: 240000593/PCBB-HN
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Device Details

Quantitative Total Bilirubin Test Reagent
VN: Thuốc thử xét nghiệm định lượng bilirubin toàn phần
Risk Class TTBYT Loại B

Registration Details

240000593/PCBB-HN

000.00.19.H26-240130-0002

Theo theo phụ lục

Theo phụ lục

Technical Details

The Total Bilirubin2 test is performed to quantify the total bilirubin in the serum or plasma of adults and newborns on the ARCHITECT c Systems. Total bilirubin is an organic compound formed in the normal and abnormal breakdown of red blood cells. Measuring the concentration of total bilirubin is used in the diagnosis and treatment of liver disorders, hemolysis, hematology, and metabolism, including liver disease and disorders of the bile ducts. In newborns, the Total Bilirubin2 test is used to measure the concentration of total bilirubin (both conjugated and unconjugated forms) in the serum or plasma to support the diagnosis and treatment of neonatal jaundice and hemolysis in newborns.

Dates and Status

Mar 21, 2024

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