A review of new, successful treatment options for the novel coronavirus.
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 PCR and real-time PCR molecular diagnostics was valued at $4 billion in 2019.
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.
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.