Lucira Health’s single-use molecular test kit will be available for prescription home use in people age 14 and older.
Part three of this series discusses the key defenses available to each element of a lawsuit against providers and labs.
The serology test is the first of its kind to detect neutralizing antibodies from a recent or prior SARS-CoV-2 infection.
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.