IVD Department Quantitative Free PSA Testing
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Apr 10, 2024- Analysis ID
- 2400525ĐKLH/BYT-HTTB
- Submission ID
- 17005825/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- CÔNG TY TNHH ROCHE VIỆT NAM
- Intended Use
- 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.
- Registration Date
- Apr 10, 2024
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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.
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