Regulatory

ProFlu+ is CE Marked.

Declaration of Conformity.

ProFlu+ is licensed for sale in Canada.

FDA Cleared in January, 2008 (K073029).
Press Release

Modified in May, 2008 (K081830) for addition of easyMAG extraction and removal of culture backup recommendation for Influenza A and Influenza B.
Press Release

Modified in August, 2009 (K092500) for 2009 H1N1 reactivity.  Assay correctly identifies samples containing 2009 H1N1 virus as Influenza A, but does not differentiate Influenza A subtypes.
Press Release