Revvity secures FDA clearance for total testosterone immunoassay

The assay enables ChLIA measurement of testosterone markers, delivering diagnostic capabilities for suspected male hypogonadism.

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.

The new offering allows for direct ChLIA measurements of SHBG, total testosterone, and free testosterone, delivering key first- and second-line diagnostic capabilities in the identification of suspected hypogonadism in men.

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