Vietnam MOH registration 2400502ĐKLH/BYT-HTTB

PSA Free Quantitative Testing Drug

VN: Thuốc thử xét nghiệm định lượng PSA tự do

Vietnam·Risk Class TTBYT Loại C·Elecsys free PSA·Roche Diagnostics (Suzhou) Ltd.·Registered Apr 10, 2024

Registration details

Analysis ID: 2400502ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230522-0008
Product Type: Elecsys free PSA
Product Code: 08828610214

Company information

Manufacturer: Roche Diagnostics (Suzhou) Ltd.
Manufacturer Country: CHINA
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: 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

Registration Date: Apr 10, 2024

About this record

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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