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Monday, Aug 19
Quidel receives FDA 510K clearance for its RSV immunoassay test
- 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.