IVD Department quantitative test for the surface antigen of hepatitis B virus (HBsAg) - Vietnam Registration 2301812ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department quantitative test for the surface antigen of hepatitis B virus (HBsAg) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2301812ĐKLH/BYT-HTTB and manufactured by Theo theo phụ lục.
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Device Details
Registration Details
2301812ĐKLH/BYT-HTTB
17001244/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
Alinity i HBsAg Calibrators are used to calibrate the Alinity i analyzer when performing quantitative testing of the hepatitis B surface antigen (HBsAg) in human serum and plasma. Alinity i HBsAg Controls are used to monitor the calibration of the Alinity i analyzer when performing quantitative testing of the hepatitis B surface antigen (HBsAg) in human serum and plasma. The Alinity i HBsAg test is a chemiluminescent microparticle immunoassay (CMIA) used to quantitate the hepatitis B surface antigen (HBsAg) in human serum and plasma samples on the Alinity i analyzer.
Dates and Status
Dec 30, 2023