IVD Department Quantitative Free PSA Testing - Vietnam Registration 2400525ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department Quantitative Free PSA 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 2400525ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Theo phụ lục, Beckman Coulter, Inc., 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
2400525ĐKLH/BYT-HTTB
17005825/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
Elecsys free PSA: An in vitro immunoassay test used to quantify the concentration of free prostate-specific antigen (PSA) in human serum and plasma. This test is indicated to measure fPSA in combination with the Elecsys total PSA test to determine the ratio of fPSA to tPSA (% fPSA). This ratio is useful in combination with the Elecsys total PSA test to help differentiate between prostate cancer and benign prostatic conditions in men over 50 years of age who have undergone a digital rectal examination (DRE) and were found to have no suspicious signs of prostate cancer and have a value of the Elecsys total PSA test in the range of 4 ng/mL to 10 ng/mL. Prostate biopsy is required to diagnose prostate cancer. The "ECLIA" (electrochemiluminescence immunoassay "ECLIA") is used for the cobas e immunoassay analyzer.
Dates and Status
Apr 10, 2024