Feds Seeking A Few Good Tests, And Masks, For Flu Season
This article was originally published in The Gray Sheet
Executive Summary
With an especially challenging flu season expected this year, government officials are scrambling to evaluate the tools they have available to monitor, diagnose and limit spread of the virus
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FDA grants emergency use authorization to Roche's RealTime Ready Influenza A/H1N1 Detection Set,which will allow clinicians to test for the presence of the 2009 H1N1 influenza virus collected via nasopharyngeal swabs, nasal swabs, washes and aspirates in clinical settings, and "augment existing testing capacity" for the H1N1 virus, FDA says in its Nov. 13 EUA letter. FDA has also granted emergency use authorization for use of Roche's Detection Set on the company's LightCycler 2.0 ("1The Gray Sheet" Aug. 24, 2009)
Roche H1N1 flu test wins emergency clearance
FDA grants emergency use authorization to Roche's RealTime Ready Influenza A/H1N1 Detection Set,which will allow clinicians to test for the presence of the 2009 H1N1 influenza virus collected via nasopharyngeal swabs, nasal swabs, washes and aspirates in clinical settings, and "augment existing testing capacity" for the H1N1 virus, FDA says in its Nov. 13 EUA letter. FDA has also granted emergency use authorization for use of Roche's Detection Set on the company's LightCycler 2.0 ("1The Gray Sheet" Aug. 24, 2009)
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