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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: 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
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
- Letter of Authorization
- Amendment to the Emergency Use of Focus Diagnostic Influenza AH1N1 (2009) Real-Time RT-PCR
- Fact Sheet for Healthcare Providers
- Fact Sheet for Patients
- Labeling (PDF)
RT-PCR Detection Panel (H1N1 Influenza Test Kit - amended May 2, 2009)
- Letter of Authorization
- Amendment to RT-PCR Detection Panel
- Fact Sheet for Healthcare Providers
- Fact Sheet for Patients
- Labeling (PDF)
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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