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.

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