The agency stated that Battelle Memorial Institute is not in compliance with reporting requirements related to its CCDS.
Part one of this series looks at the claims brought against manufacturers of diagnostic test kits.
AdvaMed’s Diagnostic Supply Registry is tracking the progress of molecular diagnostic tests to help support state and federal governments.
The authorization is a step toward broad screening that will help reopen schools and workplaces in America, says FDA Commissioner Stephen Hahn, M.D.
Illumina’s COVIDSeq Test enables qualitative detection of SARS-CoV-2 RNA from respiratory specimens.
The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.
The continued threat and spread of COVID-19 across the globe has led to seismic uncertainty for every industry.
Don’t miss this opportunity to learn how your company can effectively push its product to the finish line.
The prescription-only diagnostic allows patients to self-collect saliva samples to test for SARS-CoV-2.
COVID-19 requires us to rethink our current device disinfection procedure.