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Approval for the dimension(r) rxl psa flex(r) reagent cartridge. The device is indicated for the following: the psa method for the dimension(r) clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure prostate specific antigen (psa) in human serum: 1) as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (dre) in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. 2) as an aid in the management (monitoring) of prostate cancer patients.
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