Medical Devices and Flu Emergencies

This website is archived for historical purposes and is no longer being maintained or updated. For updated information on the current flu season, see the Seasonal Flu (Influenza) and the FDA website.

Recent Information:

• Letter: Termination of Declaration of Emergency Justifying Emergency Use Authorization (EUA) of Certain In Vitro Diagnostic Tests (6/22/10)
• Letter: Termination of Declaration of Emergency Justifying the Authorization of Emergency Use of Certain Personal Respiratory Protection Devices (6/22/10)
• Letter: Disposition of Certain Personal Respiratory Protection Devices Authorized for Emergency Use (6/22/10)
• Federal Register: Termination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protection Devices (6/25/10)

Historical Information

The information previously contained on these webpages were authorized under the 2009 H1N1 Influenza Emergency Use Authorizations (EUAs). As of June 23, 2010, the EUAs have been terminated and this information is no longer current.

Personal Protective Equipment (PPE)

Personal Protective Equipment	Date*	Letter of Authorization	Fact Sheet
Disposable N95 Respirators from Strategic National Stockpile	5/1/09	[Authorization] [Amendment]	[Fact Sheet]

In Vitro Diagnostics (IVD)

Test	Date*	Letter of Authorization	Fact Sheet for Healthcare Providers	Fact Sheet for Patients	Labeling (PDF)
CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel with additional specimens and reagents	5/2/09	[Authorization]	[Healthcare]	[Patients]	[Labeling]
CDC rRT-PCR Swine Flu Panel on the Joint Biological Agent Identification and Diagnostic System (JBAIDS) Instrument	12/18/09	[Authorization]	[Healthcare]	[Patients]	[Labeling]
CDC Swine Influenza Virus Real-time RT-PCR Detection Panel	12/18/09	[Authorization]	[Healthcare]	[Patients]	[Labeling]
Cepheid Xpert® Flu A Panel for the Diagnosis of 2009 H1N1 Influenza Virus Infection	12/24/09	[Authorization]	[Healthcare]	[Patients]	[Labeling]
Diagnostic Hybrids, Inc. D3 Ultra 2009 H1N1 Influenza A Virus ID Kit	2/16/10	[Authorization]	[Healthcare]	[Patients]	[Labeling]
Diatherix 2009 H1N1 Test	10/9/09	[Authorization]	[Healthcare]	[Patients]	[Labeling]
ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test	2/1/10	[Authorization]	[Healthcare]	[Patients]	[Labeling]
Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR	12/18/09	[Authorization]	[Healthcare]	[Patients]	[Labeling]
Focus Diagnostics Simplexa™ Influenza A H1N1 (2009) Test	12/18/09	[Authorization]	[Healthcare]	[Patients]	[Labeling]
GeneSTAT 2009 A/H1N1 Influenza Test	12/9/09	[Authorization]	[Healthcare]	[Patients]	[Labeling]
IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay from IntelligentMDx	3/22/10	[Authorization]	[Healthcare]	[Patients]	[Labeling]
IQuum Liat™ Influenza A/2009 H1N1 Assay	5/4/10	[Authorization]	[Healthcare]	[Patients]	[Labeling]
Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay	3/23/10	[Authorization]	[Healthcare]	[Patients]	[Labeling]
Prodesse ProFlu-ST Influenza A assay for the diagnosis of 2009 H1N1 Influenza virus infection	10/27/09	[Authorization]	[Healthcare]	[Patients]	[Labeling]
Qiagen artus® Inf. A H1N1 2009 LC RT-PCR Kit	3/11/10	[Authorization]	[Healthcare]	[Patients]	[Labeling]
Roche RealTime ready Influenza A/H1N1 Test	11/13/09	[Authorization]	[Healthcare]	[Patients]	[Labeling]
TessArray Resequencing Influenza A Microarray Detection Panel	12/16/09	[Authorization]	[Healthcare]	[Patients]	[Labeling]
ViraCor 2009 H1N1 Influenza A Real-time RT-PCR	1/21/10	[Authorization]	[Healthcare]	[Patients]	[Labeling]

* Date of Authorization or of Latest Amendment