PHASE Scientific, the exclusive U.S. distributor of FebriDx® under its previously announced distribution agreement with Lumos Diagnostics, today announced that the U.S. Food and Drug Administration (FDA) has granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for FebriDx®, following the test’s 510(k) clearance (K260787).
The CLIA waiver materially expands the settings in which FebriDx can be used, enabling broad adoption across CLIA-waived point-of-care (POC) environments and significantly increasing the reachable customer base. FebriDx is a rapid POC test that helps clinicians differentiate between bacterial and non-bacterial respiratory infections in approximately 10 minutes using a fingerstick blood sample. Read More >



