Severe acute respiratory syndrome-associated coronavirus IVDs

Intended purpose

The Panther Fusion SARS-CoV-2 assay is a real-time PCR in vitro diagnostic tests intended for the rapid and presumptive qualitative detection of RNA from the SARSCoV-2 isolated and purified from nasopharyngeal (NP) and oropharyngeal (OP) swab specimens obtained from individuals meeting Department of Health SARS-CoV-2 criteria for SARSCoV-2 testing.