IVD Department Qualitative Antibody to HBcAg Testing - Vietnam Registration 2403712ĐKLH/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 TBYT Loại D medical device is registered under number 2403712ĐKLH/BYT-HTTB and manufactured by Beckman Coulter, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 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
2403712ĐKLH/BYT-HTTB
17003964/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
1. The Access HBc Ab test is an integrated qualitative immunoassay that detects antibodies against the core antigen of the hepatitis B virus (HBcAg) in human serum or plasma. 2. Access HBc Ab Calibrators are used in the Access HBc Ab test to detect total anti-HBc antibodies in human serum or plasma using the Access immunoassay systems. 3. Access HBc Ab QC is used to monitor the performance of the Access HBc Ab test system.
Dates and Status
Nov 19, 2024