Intended use:
The PSA Semi-quantitative Rapid Test is a lateral flow
chromatographic immunoassay for the semi-quantitative
detection of prostate specific antigen (PSA) in human
whole blood, serum or plasma at a cut-off level of 4 ng/mL.
It is intended to be used by healthcare professionals to aid
in the diagnosis of prostate cancer. Any interpretation or
use of this preliminary test result must also rely on other
clinical findings as well as on the professional judgment of
health care providers. Alternative test method(s) should be
considered to confirm the test result obtained by this
device.
