DevicePMAs@therightstef:P170037_S000 JSONTXT 13 Projects

Approval for the Sangia Total PSA Test. The Sangia Total PSA Test is an immunoassay indicated to quantitatively measure total PSA in capillary whole blood from a fingerstick collected by a healthcare professional and is used in conjunction with a digital rectal exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years and older. The Sangia Total PSA Test is performed using the Claros 1 Analyzer in point-of-care settings. A prostate biopsy is required for the diagnosis of prostate cancer.