Washington D.C.—The FDA has issued an Emergency Use Authorization (EUA) for 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.
The EUA allows Focus Diagnostics to distribute the test to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests. This test is not typically utilized in a doctor’s office—it is a complex laboratory test performed in an environment that has the necessary equipment. These tests are intended for use in the detection of the 2009 H1N1 influenza virus in patients with symptoms of respiratory infection.
“This authorization will contribute to the nation’s capacity for accurate testing for the 2009 H1N1 influenza virus,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health.
The full story is available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173543.htm
No more results found. 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.
The EUA allows Focus Diagnostics to distribute the test to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests. This test is not typically utilized in a doctor’s office—it is a complex laboratory test performed in an environment that has the necessary equipment. These tests are intended for use in the detection of the 2009 H1N1 influenza virus in patients with symptoms of respiratory infection.
“This authorization will contribute to the nation’s capacity for accurate testing for the 2009 H1N1 influenza virus,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health.
The full story is available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173543.htm