Historical Information about Device Emergency Use Authorizations
This page is intended to provide reference information on EUAs that were previously issued but no longer in effect, including revoked EUAs. Information about why each EUA was revoked is available in its revocation letter, available in the tables below.
On this page:
- Infusion Pumps
- In Vitro Diagnostics (IVD)
- Personal Protective Equipment (PPE)
- Decontamination Systems for PPE
Infusion Pumps
| Medical Product | Date** | Most Recent Letter of Authorization and Other EUA-Related Information | Fact Sheets and Manufacturer Instructions / Package Insert |
|---|---|---|---|
| Infusion Pumps and Infusion Pump Accessories (umbrella) |
05/13/2020 (issued) 09/21/2020 (revoked) |
Federal Register notices: |
|
In Vitro Diagnostics (IVD)
| Medical Product | Date** | Most Recent Letter of Authorization and Other EUA-Related Information | Fact Sheets and Manufacturer Instructions / Package Insert |
|---|---|---|---|
| qSanger-COVID-19 Assay |
09/04/2020 (issued) 06/23/2021 (revised) 09/23/2021 (revised) 03/10/2022 (revoked) |
|
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| Diagnovital SARS-CoV-2 Real-Time PCR Kit |
06/12/2020 (issued) 09/23/2021 (revised) 03/14/2022 (revoked) |
|
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| CentoFast-SARS-CoV-2 RT-PCR Assay |
07/01/2020 (issued) 08/13/2021 (revised) 09/23/2021 (revised) 03/17/2022 (revoked) |
|
|
| CentoSure SARS-CoV-2 RT-PCR Assay |
09/29/2020 (issued) 08/13/2021 (revised) 09/23/2021 (revised) 03/17/2022 (revoked) |
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| DiaSorin LIAISON SARS-CoV-2 IgM Assay |
09/29/2020 (issued) 09/23/2021 (revised) 03/15/2022 (revoked) |
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|
|
BinaxNOW COVID-19 Ag Card 2 Home Test |
03/31/2021 (issued) 09/23/2021 (revised) 01/07/2022 (revised) 02/24/2022 (revoked) |
Federal Register notices: |
|
| Omni COVID-19 Assay by RT-PCR |
06/17/2020 (issued) 12/28/2020 (revised) 09/23/2021 (revised) 02/14/2022 (revoked) |
Federal Register notices: |
|
|
LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel |
06/29/2020 (issued) 09/23/2021 (revised) 02/07/2022 (revoked) |
Federal Register notices: |
|
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MosaiQ COVID-19 Antibody Magazine |
09/25/2020 (issued) 04/27/2021 (revised) 09/23/2021 (revised) 01/11/2022 (revoked) |
Federal Register notices: |
|
|
BioPlex 2200 SARS-CoV-2 IgG |
07/01/2021 (issued) 09/23/2021 (revised) 01/11/2022 (revoked) |
Federal Register notices: |
|
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Xpert Omni SARS-CoV-2 |
11/27/2020 (issued) 12/23/2020 (revised) 04/20/2021 (reissued) 09/23/2021 (revised) 12/20/2021 (revoked) |
Federal Register notices: |
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ADVIA Centaur SARS-CoV-2 IgG (COV2G) |
07/31/2020 (issued) 09/23/2021 (revised) 12/17/2021 (revoked) |
Federal Register notices: |
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Atellica IM SARS-CoV-2 IgG (COV2G) |
07/31/2020 (issued) 09/23/2021 (revised) 12/17/2021 (revoked) |
Federal Register notices: |
|
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SARS-COV-2 R-GENE |
05/06/2020 (issued) 11/06/2020 (amended) 09/23/2021 (revised) 12/17/2021 (revoked) |
Federal Register notices: |
|
|
qSARS-CoV-2 IgG/IgM Rapid Test |
04/01/2020 (issued) 06/12/2020 (reissued) 09/23/2021 (revised) 12/10/2021 (revoked) |
Federal Register notices: |
|
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BMC-CReM COVID-19 Test |
07/10/2020 (issued) 09/25/2020 (amended) 09/23/2021 (revised) 12/08/2021 (revoked) |
Federal Register notices: |
|
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Akron Children's Hospital SARS-CoV-2 Assay |
09/29/2020 (issued) 09/23/2021 (revised) 12/08/2021 (revoked) |
Federal Register notices: |
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BioGX SARS-CoV-2 Reagents for BD MAX System |
04/02/2020 (issued) 04/07/2020 (amended) 05/29/2020 (amended) 09/25/2020 (amended) 09/23/2021 (revised) 12/08/2021 (revoked) |
Federal Register notices: |
|
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TaqPath COVID-19 MS2 Combo Kit 2.0 |
08/02/2021 (issued) 09/27/2021 (revoked) |
Federal Register notices: |
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Guardant-19 |
08/21/2020 (issued) 12/28/2020 (amended) 08/06/2021 (revoked) |
Federal Register notices: |
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MatMaCorp COVID-19 2SF Test |
12/17/2020 (issued) 08/03/2021 (revoked) |
Federal Register notices: |
|
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Gravity Diagnostics COVID-19 Assay |
06/01/2020 (issued) 06/30/2020 (amended) 09/10/2021 (updaed) 07/21/2021 (revoked) |
Federal Register notices: |
|
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Curative-Korva SARS-Cov-2 Assay (original name) |
04/16/2020 (issued) 07/15/2021 (revoked) |
Federal Register notices: |
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| BioFire Respiratory Panel 2.1 (RP2.1) (BioFire Diagnostics, LLC) |
05/01/2020 (issued) 03/17/2021 (revoked) |
Federal Register notices: |
|
| Anti-SARS-CoV-2 Rapid Test (Autobio Diagnostics Co. Ltd.) |
04/24/2020 (issued) 08/06/2020 (revoked) |
Federal Register notices: |
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| DPP COVID-19 IgM/IgG System (Chembio Diagnostic System, Inc.) |
04/14/2020 (issued) 06/16/2020 (revoked) |
Federal Register notices: |
|
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DPP Zika IgM Assay System (Chembio Diagnostic Systems, Inc.) |
08/03/2018 |
Federal Register (FR) notices: |
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ADVIA Centaur Zika test (Siemens Healthcare Diagnostics Inc.) |
09/18/2017 (initial issuance) 11/16/2017 (amended) 04/18/2019 (amended) 07/17/2019 (revoked) |
Federal Register (FR) notices: |
|
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ZIKV Detect 2.0 IgM Capture ELISA (InBios International, Inc.) |
08/17/2016 (initial issuance) 03/27/2017 (amended) 05/18/2018 (amended) 05/23/2019 (revoked) |
Federal Register (FR) notices: |
|
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xMAP MultiFLEX Zika RNA Assay (Luminex Corporation) |
08/04/2016 (initial issuance) 01/07/2017 (amended) 05/19/2017 (amended) 07/03/2019 (revoked) |
Federal Register (FR) notices: |
|
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LIAISON XL Zika Capture IgM Assay II (DiaSorin Incorporated) |
04/05/2017 (initial issuance) 11/06/2017 (amended) 12/27/2018 (amended) 10/28/2019 (revoked) |
Federal Register (FR) notices: |
|
|
ReEBOV Antigen Rapid Test (Zalgen Labs, LLC) |
02/24/2015 (initial issuance) 03/16/2015 (reissuance) 11/03/2016 (reissuance) 05/18/2019 (revoked) |
Federal Register (FR) notices:
|
|
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LightMix® Zika rRT-PCR Test (Roche Molecular Systems, Inc.) |
08/26/2016 |
Federal Register (FR) notices: |
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OraQuick Ebola Rapid Antigen Test (OraSure Technologies, Inc.) |
Cadaveric oral fluid 09/26/2016 (reissuance) 02/01/2019 (amended) Whole blood 01/30/2019 (amended) 10/10/2019 (revoked) |
Federal Register notices: |
|
| ReEBOV™ Antigen Rapid Test (Corgenix Inc.) |
02/24/2015 (initial issuance) 03/16/2015 (reissuance) 11/03/2016 (reissuance) 05/18/2019 (revoked) |
Federal Register notices:
|
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| IQuum Liat™ Influenza A/2009 H1N1 Assay |
05/04/2010 (initial issuance) 06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay | 03/23/2010 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay from IntelligentMDx | 03/22/2010 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| Qiagen artus® Inf. A H1N1 2009 LC RT-PCR Kit | 03/11/2010 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| Diagnostic Hybrids, Inc. D3 Ultra 2009 H1N1 Influenza A Virus ID Kit | 02/16/2010 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test | 02/01/2010 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| ViraCor 2009 H1N1 Influenza A Real-time RT-PCR | 01/21/2010 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| Cepheid Xpert® Flu A Panel for the Diagnosis of 2009 H1N1 Influenza Virus Infection | 12/24/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| CDC rRT-PCR Swine Flu Panel on the Joint Biological Agent Identification and Diagnostic System (JBAIDS) Instrument | 12/18/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| CDC Swine Influenza Virus Real-time RT-PCR Detection Panel | 12/18/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR | 12/18/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| Focus Diagnostics Simplexa™ Influenza A H1N1 (2009) Test | 12/18/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| TessArray Resequencing Influenza A Microarray Detection Panel | 12/16/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| GeneSTAT 2009 A/H1N1 Influenza Test | 12/09/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| Roche RealTime ready Influenza A/H1N1 Test | 11/13/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| Prodesse ProFlu-ST Influenza A assay for the diagnosis of 2009 H1N1 Influenza virus infection | 10/27/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| Diatherix 2009 H1N1 Test | 10/09/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel with additional specimens and reagents | 05/02/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
Personal Protective Equipment (PPE)
*Note that Secretary's determination and declaration were issued based on revised authorities under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA).
** Date of Authorization or of Latest Amendment
Decontamination Systems for Personal Protective Equipment
| Decontamination System for PPE | Date* | Letter of Authorization |
Fact Sheet |
|---|---|---|---|
| Yale New Haven Health FFR Decontamination System |
01/15/2021 (Issued) 06/30/2021 (Revoked) |
Federal Register notices: |
|
| Ecolab's Bioquell Technology System |
12/04/2020 (Issued) 06/30/2021 (Revoked) |
Federal Register notices: |
|
| Lumin LM3000 Bioburden Reduction UV System |
12/03/2020 (Issued) 06/30/2021 (Revoked) |
Federal Register notices: |
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| Roxby Development Zoe-Ann Decontamination System | 10/20/2020 (Issued) 06/30/2021 (Revoked) |
Federal Register notices: |
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| Michigan State University Decontamination System |
07/24/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
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| Technical Safety Services VHP Decontamination System |
06/13/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
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| Stryker Sustainability Solutions VHP Decontamination System |
05/27/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
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| STERIS STEAM Decon Cycle in AMSCO Medium Steam Sterilizers |
05/21/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
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| Duke Decontamination System |
05/07/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
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| Sterilucent, Inc. Sterilization System |
04/20/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
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| Stryker STERIZONE VP4 N95 Respirator Decontamination Cycle |
04/15/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
|
| Advanced Sterilization Products (ASP) STERRAD Sterilization System |
04/11/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
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| STERIS Sterilization Systems for Decontamination of N95 Respirators |
04/09/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
|
| Battelle Decontamination System |
03/28/2020 (issued) 03/29/2020 (reissued) 06/06/2020 (reissued) 01/21/2021 (reissued) 04/30/2021 (revoked) |
Additional Information: Federal Register notices: |
|
| Nova2200 for Decontaminating Compatible N95 Respirators (NovaSterilis, Inc.) |
08/20/2020 (issued) 02/12/2021 (revoked) |
Federal Register notices: |
* Date of Authorization or of Latest Amendment
Additional historical information about respirator decontamination EUAs:
- FDA Recommends Transition from Use of Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities (04/09/2021)
- Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities (06/30/2021)
- FDA in Brief: FDA Revokes Emergency Use Authorizations for Certain Respirators and Decontamination Systems as Access to N95s Increases Nationwide (06/30/2021)