Quidel Receives CE Mark for its Sofia™ Strep A FIA Test
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Quidel Corporation has announced that it has received the CE Mark for its Sofia Strep A FIA for use with its Sofia Analyzer.
Sofia is the brand name for Quidel's next generation, immunoassay system.
The Sofia Analyzer and Sofia Strep A FIA combine unique fluorescent chemistry, advanced lateral flow technology, and failure alert and fail-safe systems to ensure a reliable, objective, rapid and highly accurate diagnostic result.
This press release follows closely on the recent announcement (October 26th) of the FDA clearance of the Sofia Analyzer and Sofia Influenza A+B FIA.
The Strep A FIA is the second assay to incorporate Sofia-related immunochemistry.
The CE Mark allows Quidel to launch the Sofia Strep A FIA just before the respiratory disease season in Europe as well as in other locations outside of the United States. The product is currently not for sale in the U.S.
"We are very pleased to receive the CE Mark for Strep A on Sofia ahead of schedule. In combination with our Sofia Influenza A+B FIA, this product will provide healthcare workers with added testing versatility during this respiratory disease season," said Douglas Bryant, president and chief executive officer of Quidel Corporation.
The Sofia Strep A and Influenza A+B FIAs use the Sofia Analyzer, an instrument that is designed to quickly incorporate software upgrades for new analyte-specific algorithms as the Sofia menu of products expands.
The development of several additional FIAs for application to the Sofia Analyzer is well underway.
