IVD Department Qualitative Antibody to HBcAg Testing
Vietnam·Risk Class TBYT Loại D·Theo theo phụ lục·Beckman Coulter, Inc.·Registered Nov 19, 2024- Analysis ID
- 2403712ĐKLH/BYT-HTTB
- Submission ID
- 17003964/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Beckman Coulter, Inc.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Beckman Coulter, Inc.
- Authorized Representative
- CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG
- Intended Use
- 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.
- Registration Date
- Nov 19, 2024
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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.