Medical Devices
-
Medical Devices and Flu Emergencies
The Center for Devices and Radiological Health will update this page as new information becomes available on the 2009 H1N1 Flu Virus.
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 As of June 23, 2010, the EUAs have been terminated and this information is no longer current.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
-
-
-
-
