IVD Department quantitative CA 15-3 - Vietnam Registration 2400237ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department quantitative CA 15-3 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 2400237ĐKLH/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 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.
Device Details
Registration Details
2400237ĐKLH/BYT-HTTB
17005156/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
ACCESS BR MONITOR: Access BR Monitor is a fluorescent immunoassay, flow cytometry test to determine the quantitative concentration of the CA 15-3 antigen in human serum and plasma (heparin-anticoagulated), using the Access Immunoassay System. The test is indicated for the measurement of the CA 15-3 antigen to support the management of patients with breast cancer. The concentration of CA 15-3 should be combined with other clinical methods to monitor breast cancer. ACCESS BR MONITOR CALIBRATORS: Access BR Monitor Calibrators are used to calibrate the Access BR Monitor test - the test to determine the quantitative concentration of the CA 15-3 antigen in human serum and plasma, using the Access Immunoassay System.
Dates and Status
Feb 04, 2024