BioCentury | Feb 2, 2015
Clinical News

Sofia Strep A+ Fluorescent Immunoassay regulatory update

FDA granted 510(k) clearance and a CLIA waiver to Sofia Strep A+ Fluorescent Immunoassay from Quidel to detect infections caused by group A Streptococcus bacteria. The immunoassay runs on Quidel’s Sofia Analyzer system and uses...
BioCentury | Jul 1, 2013
Clinical News

Sofia Strep A Fluorescent Immunoassay regulatory update

Quidel said FDA granted 510(k) clearance for its Sofia Strep A Fluorescent Immunoassay to detect infections caused by group A streptococcus bacteria. The immunoassay runs on Quidel's Sofia Analyzer instrument and uses lateral flow technology...
BioCentury | Dec 12, 2011
Clinical News

Sofia Strep A Fluorescent Immunoassay regulatory update

Quidel said it received CE Mark approval for its Sofia Strep A Fluorescent Immunoassay to detect group A streptococcus infection. Quidel has not disclosed a timeline for launching the product. The immunoassay runs on Quidel's...
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