IVD Department Quantitative Free PSA Testing - Vietnam Registration 2403538ĐKLH/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 TBYT Loại C medical device is registered under number 2403538ĐKLH/BYT-HTTB and manufactured by Beckman Coulter, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.
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Device Details
Registration Details
2403538ĐKLH/BYT-HTTB
000.00.04.G18-231102-0002
Theo theo phụ lục
Theo phụ lục
Technical Details
ACCESS HYBRITECH free PSA: The Access Hybritech free PSA test is a fluorescent immunoassay, flow cytometry-based test to determine the quantitative concentration of the specific antigen of free prostate-specific antigen (free PSA) in human serum using the Access Immunoassay Systems. The Access Hybritech free PSA test is used in conjunction with the Hybritech (total) PSA test to calculate the ratio of free PSA to total PSA as a percentage (percentage free PSA). The percentage free PSA is measured by the Hybritech test and is indicated as a supportive test to differentiate prostate cancer from benign prostatic hyperplasia, when used in conjunction with the Hybritech (total) PSA test to screen men 50 years of age and older for prostate cancer - those men with a total PSA concentration of 4 - 10 ng/mL* who have a non-suspicious digital rectal examination. A prostate biopsy is required to diagnose prostate cancer. *Databased on the Hybritech Tandem calibration, the cut-off value for PSA is 4 ng/mL. The corresponding cut-off value based on the WHO calibration is 3.1 ng/mL. The range of PSA is 4 - 10 ng/mL according to the Hybritech calibration, which corresponds to a range of 3.1 - 7.8 ng/mL according to the WHO calibration. ACCESS HYBRITECH free PSA CALIBRATORS: The Access Hybritech free PSA Calibrators are used to calibrate the Access Hybritech free PSA test - the test to determine the quantitative concentration of free PSA in human serum using the Access Immunoassay Systems.
Dates and Status
Nov 14, 2024