May 25, 2010 — The US Food and Drug Administration (FDA) has issued 510(k) clearance to a new influenza test (Simplexa Influenza A H1N1 [2009] test; Quest Diagnostics Incorporated), making it the ...
Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced that the Simplexa Influenza A H1N1 (2009) test developed by ...
The Food and Drug Administration says it has approved the first diagnostic test for 2009 swine flu under its traditional approval system. The FDA previously cleared several tests on a limited basis ...
The 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 ...
Associate Professor of Emergency Medicine & Pediatrics, Department of Emergency Medicine; Faculty, Pediatric Emergency Medicine, Medical College of Georgia, Augusta, Georgia Rapid tests currently on ...
The FDA has approved the Simplexa Influenza A H1N1 (2009) assay from Focus Diagnostics for use in patients with signs and symptoms of respiratory infection. Before this approval, tests for 2009 ...
ATLANTA, Sept. 24 (UPI) -- A positive rapid test for influenza is helpful, but a negative result does not rule out pandemic influenza A H1N1 infection, U.S. health officials said. The Centers for ...
LOS ANGELES (Reuters) - Quest Diagnostics Inc's molecular test for identifying patients infected with the H1N1 flu virus has been approved by European regulators and is available for distribution to ...
HUNTSVILLE, AL -- Although it can take years for the Food and Drug Administration to approve a new drug or medical test, the FDA has granted the Huntsville-produced Diatherix H1N1-09 influenza test ...
LONDON, June 10 (Reuters) - Drugmakers are on track to have a vaccine against the new H1N1 strain of flu ready for the northern hemisphere autumn after receiving seed virus samples, company officials ...
THE H1N1 ‘POLITICAL TEST’?…. The New York Times reported today that the shortage of an H1N1 vaccine poses a “political test” for President Obama. I’m not sure if that’s a fair characterization. Indeed ...