Quantitative Total Bilirubin Test Reagent
Vietnam·Risk Class TTBYT Loại B·Total Bilirubin2·Abbott Ireland Diagnostics Division·Registered Mar 21, 2024- Analysis ID
- 240000592/PCBB-HN
- Submission ID
- 000.00.19.H26-240130-0001
- Product Type
- Total Bilirubin2
- Manufacturer
- Abbott Ireland Diagnostics Division
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI
- Intended Use
- The Total Bilirubin2 test is used to quantify the total bilirubin in the serum or plasma of adults and infants on the Alinity c system. 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 infants, the Total Bilirubin2 test is indicated 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 infants.
- 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 240000592/PCBB-HN and manufactured by Abbott Ireland Diagnostics Division. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.
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