IVD Department quantitative CA 15-3
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Beckman Coulter, Inc.·Registered Feb 04, 2024- Analysis ID
- 2400237ĐKLH/BYT-HTTB
- Submission ID
- 17005156/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
- 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.
- Registration Date
- Feb 04, 2024
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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.
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