IVD Department Qualitative Antibody to HBcAg Testing
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·Registered Nov 02, 2024- Analysis ID
- 2403242ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-231018-0005
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Authorized Representative
- CÔNG TY TNHH Y TẾ MINDRAY VIỆT NAM
- Intended Use
- 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.
- Registration Date
- Nov 02, 2024
Companies providing products similar to "IVD Department Qualitative Antibody to HBcAg Testing"
Recently registered similar products
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.