Țară: Singapore
Limbă: engleză
Sursă: HSA (Health Sciences Authority)
BECKMAN COULTER SINGAPORE PTE. LTD.
Class C IVD
Beckman Coulter Inc
Immunology
It is a paramagnetic particles, chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (free PSA) in human serum using the Access Immunoassay Systems. Access Hybritech free PSA is intended to be used with Hybritech (total) PSA to calculate the ratio of free PSA to total PSA expressed as a percentage (percent free PSA). Percent free PSA as measured by the Hybritech assay is indicated for use as an aid in distiguishing prostate cancer from benigh prostatic conditions, when used in conjunction with Hybritech (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/mL with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.
Models: Beckman Coulter Access Hybritech free PSA Reagent Pack - 37210, Beckman Coulter Access Hybritech free PSA Calibrators - 37215, Beckman Coulter Access Hybritech free PSA QC - 37219, Access® Substrate - 81906, Access® Wash Buffer II - A16792, Access® Wash Buffer II - A16793, Access® Wash Buffer II (Diluent Pack) - A79784, UniCel Dxi 800 ACCESS Immunoassay Analyzer - 973100, UniCel DxI 600 ACCESS Immunoassay Analyzer - A30260, UniCel DxI 800 ACCESS Immunoassay W/Spot B - A71456, UniCel DxI 800 ACCESS Immunoassay W/Dual Gantry - A71457, UniCel DxI 600 ACCESS Immunoassay W/Spot B - A71460, UniCel DxI 600 Access Immunoassay W/Dual Gantry - A71461, Access 2 Immunoassay Analyzer - 81600N, Unicel DxI System Software v5.1 - B47068
2012-06-26