Negara: Singapura
Bahasa: Inggris
Sumber: HSA (Health Sciences Authority)
Roche Diagnostics Asia Pacific Pte Ltd
Class C IVD
Roche Diagnostics GmbH
Pathology
Immunoassay for the in vitro quantitative determination of free prostate-specific antigen in human serum and plasma. The free PSA immunoassay is indicated for measurement of fPSA in conjunction with the Elecsys total PSA assay to develop a ratio (% fPSA) of fPSA to tPSA. This ratio is useful when used in conjunction with the Elecsys total PSA test as an aid in distinguishing prostate cancer from benign prostatic conditions in men age 50 years or older who have a digital rectal examination (DRE) that is not suspicious for prostate cancer and an total PSA value in the range 4 ng/mL to 10 ng/mL. Prostate biopsy is required for the diagnosis of prostate cancer. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.
Models: Elecsys free PSA - 03289788190, free PSA CalSet - 03289796190, PreciControl Tumor Marker - 11776452122, Elecsys free PSA - 07027320190, Elecsys free PSA - 08828601190, Elecsys free PSA - 08828610190, free PSA CalSet - 08851964190, Elecsys free PSA - 08828610214
2010-08-19