Comprehensive Quantitative PSA Test Kit - Vietnam Registration 2403374ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Comprehensive Quantitative PSA Test Kit 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 2403374ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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Device Details
Registration Details
2403374ĐKLH/BYT-HTTB
18006370/ĐKLH-BYT-TB-CT
Elecsys total PSA
08791716190
Technical Details
This test is used in vitro diagnostic to quantify the total specific prostate antigen (free+complexed) in human serum and plasma, and is recommended to measure the total PSA along with digital rectal examination (DRE) to aid in the detection of prostate cancer in men aged 50 and above. Prostate biopsy is required for the diagnosis of prostate cancer. Additionally, the test is recommended to measure tPSA over time to support the monitoring of cancer patients. The "ECLIA" fluorescent immunoassay is used in the cobase601 and cobase602 diagnostic test systems.
Dates and Status
Nov 06, 2024