It’s All So Simple Now: The First Traditional Marketing Authorization for a Non-PCR Based Test to Detect SARS-CoV-2
FDA Law
MARCH 16, 2023
Baumhardt, Senior Medical Device Regulation Expert — On March 8th FDA granted Quidel’s Sofia 2 SARS Antigen+ FIA and Sofia 2 SARS Antigen+ FIA Control Swab Set. The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., By Richard A.
Let's personalize your content