Quantitative Total Bilirubin Test Reagent
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Registered Mar 21, 2024- Analysis ID
- 240000593/PCBB-HN
- Submission ID
- 000.00.19.H26-240130-0002
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI
- Intended Use
- 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.
- Registration Date
- Mar 21, 2024
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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.
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