IVD Department quantitative CK-MB testing
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Apr 10, 2024- Analysis ID
- 2400504ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-230425-0012
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- CÔNG TY TNHH VẠN NIÊN
- Intended Use
- CK-MB FS: A quantitative in vitro diagnostic test for CK-MB in human serum or lithium heparin plasma, performed on the BioMajesty® JCA-BM6010/C automated system. TruCal CK-MB: A calibrator to be used in quantitative in vitro diagnostic tests for CK-MB activity on various measurement systems. TruLab N: A quality control material for in vitro diagnostic tests to monitor the performance of quantitative in vitro diagnostic tests for different analytes. TruLab P: A quality control material for in vitro diagnostic tests to monitor the performance of quantitative in vitro diagnostic tests for different analytes.
- Registration Date
- Apr 10, 2024
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Access comprehensive regulatory information for IVD Department quantitative CK-MB testing 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 2400504ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH VẠN NIÊN.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including SD Biosensor, Inc., Theo theo phụ lục, and 2 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.