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BECKMAN COULTER SINGAPORE PTE. LTD.
Class C IVD
Beckman Coulter Inc
It is a paramagnetic particle, chemiluninescent 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 biopsayis required for the diagnosis of cancer. The device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.