IVD Department Qualitative Antibody to HBcAg Testing - Vietnam Registration 2403242ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department Qualitative Antibody to HBcAg Testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2403242ĐKLH/BYT-HTTB and manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH Y TẾ MINDRAY VIỆT NAM.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Beckman Coulter, Inc., and 1 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.
Device Details
Registration Details
2403242ĐKLH/BYT-HTTB
000.00.04.G18-231018-0005
Theo theo phụ lục
Theo phụ lục
Technical Details
The Anti-HBc CL-series test is a CLIA (Chemiluminescent Immunoassay) test for the qualitative detection of antibodies against the core antigen of the hepatitis B virus (Anti-HBc) in human serum or plasma. The test is used to support the diagnosis of hepatitis B virus (HBV) infection and blood donation screening and the screening of blood components. The Mindray Anti-HBc Calibrators (Anti-HBc CAL) are used to calibrate the qualitative Anti-HBc test for the detection of antibodies against the core antigen of the hepatitis B virus (Anti-HBc) in human serum and plasma on the Mindray CL-Series immunoassay analyzer. The Anti-HBc Positive Control is used to monitor the accuracy and reproducibility of the qualitative Anti-HBc test for the detection of antibodies against the core antigen of the hepatitis B virus (Anti-HBc) on the Mindray CL-series immunoassay analyzer. The product is also used to assess the quality control capability of clinical laboratories. The Anti-HBc Negative Control is used to monitor the accuracy and reproducibility of the qualitative Anti-HBc test for the detection of antibodies against the core antigen of the hepatitis B virus (Anti-HBc) on the Mindray CL-series immunoassay analyzer. The product is also used to assess the quality control capability of clinical laboratories.
Dates and Status
Nov 02, 2024