Part one of this series looks at the claims brought against manufacturers of diagnostic test kits.
The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.
The Abbott ID NOW test may return false negative results.
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.
Diagnostic companies are hustling to increase availability of testing.
Due to the public health emergency, the agency is implementing the guidance document immediately, without public comment.