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Beyond EUA: FDA Grants 510(k) Clearance for a COVID-19 Test

On Jan. 27, BioFire Defense's COVID-19 Test 2, an assay developed in collaboration with the U.S. Army, received 510(k) clearance from the FDA. Previously, the test had been cleared only for emergency use. And that’s a big deal. In fact, almost all of the more than...

Pcr well plate on 96 well microplate with biological samples.

COVID-19 Testing Company in Hot Water for Numerous Infractions

An Illinois-based COVID-19 testing company and its laboratory is facing lawsuits from two different states as well as investigations from several state and federal authorities after patient and employee complaints brought to light a number of problems. The Center...

A gavel on a medical mask.