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.
The medical device industry is pressured to aid those stricken by the pandemic, while at the same time working to mitigate increased risks usually associated with hurried manufacturing and quality control procedures.
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.