FDA Authorizes Emergency Use of Another Test for 2009 H1N1 Influenza Virus

FDA Authorizes Emergency Use of Another Test for 2009 H1N1 Influenza Virus
Fri, 24 Jul 2009 20:00:00 -0500

The U.S. Food and Drug Administration today announced it has issued an Emergency Use Authorization (EUA) for a another diagnostic test for the 2009 H1N1 influenza virus, whose spread has caused the virus to be characterized as a pandemic by the World Health Organization. The EUA for the Focus Diagnostics Influenza H1N1 (2009) Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) diagnostic test is the third diagnostic test authorized under an EUA by the FDA since the public health emergency involving the 2009 H1N1 influenza virus was declared on April 26, 2009.