LDX Chart, page-731

ViraDx has emergency use because it's a covid and flu A & B test which are in high demand as America enters winter. It also has a CLIA waiver for all clinics i.e. 260,000 settings.

FebriDx is currently only approved in lab type settings (10,000 settings).
They need CLIA waiver to be approved for hospital and doctor use etc i.e. 260,000 settings.

CLIA waiver should just be a formality. It is about ensuring people are given the right instructions or trained as necessary to ensure they complete the test properly ensuring accuracy. Everyone knows how to do saliva POC test like covid, but a blood test on a reader to ensure high accuracy will need to ensure people know how to do it properly.

FebriDx is approved and can be used but not for the wider medical settings until CLIA waiver is completed.

As I understand it they have geared up some inventory of FebriDx ready for when all clear and first big distribution agreements are signed.