- Quidel (QDEL +0.1%) ticks up after saying it's received FDA 510(k) clearnace for its Sofia RSV Fluorescent Immunoassay test for use with its Sofia Analyzer, for the detection of respiratory syncytial virus infections.
- The clearance allows it to market and sell its new Sofia RSV FIA in the United States.
- The Sofia Analyzer was cleared in October of 2011, and in addition to the RSV application,
- Sofia now enables rapid immunofluorescence assays for three other FDA-cleared FIAs: Influenza A+B, Strep A and hCG for pregnancy.
at Zacks.com (Nov 5, 2014)