2 results
Approved WMOCompleted
Primary clinical investigation objectives[Safety]The primary safety objective of the clinical investigation is to provide data that demonstrates safety of the device, defined as < 8.3% serious adverse device effects, up to 6 weeks following…
Approved WMOPending
The primary objective of this study is to validate the accuracy of FebriDx to discriminate between viral and/or bacterial respiratory infections. Besides this, the predictive value (negative predictive value (NPV) and positive predictive value (PPV…