PSA Free Quantitative Testing Drug - Vietnam Registration 2400502ĐKLH/BYT-HTTB
Access comprehensive regulatory information for PSA Free Quantitative Testing Drug 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 2400502ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics (Suzhou) Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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Device Details
Registration Details
2400502ĐKLH/BYT-HTTB
000.00.04.G18-230522-0008
Elecsys free PSA
08828610214
Technical Details
In vitro immunoassay for the quantitative determination of free prostate-specific antigen (fPSA) in human serum and plasma. This test is indicated to measure fPSA in combination with the Elecsys total PSA test to determine the fPSA/tPSA ratio (% fPSA). This ratio is useful in combination with the Elecsys total PSA test to help differentiate prostate cancer from benign prostatic conditions in men over 50 years of age who have undergone a digital rectal examination (DRE) and who do not have any 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") immunoassay is used in the cobas e immunoassay system.
Dates and Status
Apr 10, 2024