Beckman Coulter, Inc. 37200 Access Hybritech PSA

The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems. This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.