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FDA > CDRH > Medical Devices for Flu Diagnosis and Protection

Medical Devices for Flu Diagnosis and Protection

2009 H1N1 Flu Virus (Swine Flu) Update: May 6

The Center for Devices and Radiological Health will update this page as new information becomes available on the 2009 H1N1 Flu Virus.

Medical Device Emergency Authorizations

RT-PCR Detection Panel (H1N1 Influenza Test Kit - amended May 2, 2009)

Emergency Use of Previously Cleared CDC rRT-PCR Flu Panel to Allow Additional Reagents and Specimens

Emergency Use of Disposable N95 Respirators from Strategic National Stockpile
FDA Information on 2009 H1N1 Flu Virus - PandemicFlu.gov
Centers for Disease Control and Prevention (CDC) 2009 H1N1 Influenza Web Site

Additional Information

Updated May 6, 2009

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