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October 30, 2011

FDA clears Quidel analyser and influenza assay

Quidel, a rapid diagnostic testing solutions and cell-based virology assays provider, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Sofia analyser and Sofia Influenza A+B Fluorescent Immunoassay (FIA).

Quidel, a rapid diagnostic testing solutions and cell-based virology assays provider, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Sofia analyser and Sofia Influenza A+B Fluorescent Immunoassay (FIA).

The Influenza A+B FIA utilises lateral flow and immunofluorescence technologies to provide clinical sensitivity for influenza A and B.

The Sofia analyser can be installed in laboratories, hospitals, medical centres, and small clinics.

The results are readily available on the instrument’s screen, in a hard-copy printout, as well as in electronic form that can network via an LIS system to hospital and medical centre databases.

The company said both the Sofia analyser and the Influenza A+B FIA have received the CE Mark in August 2011.

 

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