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Medical Devices

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Medical Devices and Flu Emergencies

Medical Devices for Flu Diagnosis and Protection

2009 H1N1 Flu Virus (Swine Flu) Update: October 29, 2009

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

Emergency Use of Prodesse ProFlu-ST Influenza A assay for the diagnosis of 2009 H1N1 Influenza virus infection

Emergency Use of Focus Diagnostics Simplexa™ Influenza A H1N1 (2009) Test

Emergency Use of Diatherix 2009 H1N1 Test

Emergency Use of rRT-PCR Swine Flu Panel on JBAIDS

Emergency Use of Focus Diagnostic Influenza AH1N1 (2009) Real-Time RT-PCR for the diagnosis of 2009 H1N1 Influenza Virus Infection

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

    
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Additional Information

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