Revvity secures FDA clearance for total testosterone immunoassay

Revvity has received FDA clearance for its total testosterone automated ChLIA via its Immunodiagnostic Systems subsidiary. The assay enables ChLIA measurement of testosterone markers, delivering diagnostic capabilities for suspected male hypogonadism. The portfolio runs on IDS’ automation platforms. Credit: aslysun / Shutterstock.com. Revvity has received clearance from the US Food and Drug Administration (FDA) for its total testosterone automated chemiluminescence immunoassay (ChLIA) via its Immunodiagnostic Systems (IDS) subsidiary. This addition further supports Revvity’s FDA-cleared ChLIA tests for free testosterone and sex hormone-binding globulin (SHBG), offering a fully integrated approach for testosterone-related disorder diagnostics on one platform. Combine business intelligence and…

Source: Medical Device Network