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This page is intended to provide reference information on EUAs that were previously issued but no longer in effect, including revoked EUAs. Information about why each EUA was revoked is available in its revocation letter, available in the tables below.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 |
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B. Braun Space and Outlook Pumps |
04/11/2020 (issued) 10/1/2024 (revoked) |
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Infusion Pumps and Infusion Pump Accessories (umbrella) |
05/13/2020 (issued) 09/21/2020 (revoked) |
Federal Register Notices: |
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In Vitro Diagnostics (IVD)
Medical Product | Date** | Most Recent Letter of Authorization and Other EUA-Related Information | Fact Sheets and Manufacturer Instructions / Package Insert |
---|---|---|---|
Cue COVID-19 Test for Home and Over The Counter (OTC) Use |
03/05/2021 (issued) 09/23/2021 (revised) 01/21/2022 (revised), 02/09/2022 (revised), 08/24/2022 (revised) 10/09/2024 (revoked) |
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Cue COVID-19 Test |
06/10/2020 (issued) 08/20/2020 (revised) 03/26/2021 (reissued) 09/23/2021 (revised) 03/01/2022 (revised) 03/09/2022 (revised) 03/08/2023 (revised) 10/09/2024 (revoked) |
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Procleix SARS-CoV-2 Assay |
02/10/2021 (issued) 9/23/2021 (revised) 08/15/2024 (revoked) |
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LumiraDx SARS-CoV-2 RNA STAR |
08/11/2020 (issued) 11/28/2020 (revised) 09/23/2021 (revised) 02/24/2023 (revised) 07/18/2023 (revised) 08/21/2024 (revoked) |
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cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) |
06/17/2021 (issued) 09/23/2021 (revised) 01/04/2022 (revised) 08/11/2022 (revised) 10/26/2022 (revised) 02/16/2023 (revised) 05/18/2023 (revised) 06/16/2023 (revised) 08/02/2023 (revised) 08/05/2024 (revoked) |
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LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete Assay |
02/03/2023 (issued) 06/30/2023 (revised) 08/07/2024 (revoked) |
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Sampinute COVID-19 Antigen MIA |
10/23/2020 (issued) 09/23/2021 (revised) 11/01/2022 (revised) 03/27/2023 (revised) 07/30/2024 (revoked) |
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Celltrion DiaTrust COVID-19 Ag Home Test |
10/21/2021 (issued) 05/20/2022 (reissued) 11/01/2022 (revised) 11/04/2022 (revised) 01/20/2023 (revised) 03/02/2023 (revised) 07/30/2024 (revoked) |
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Celltrion DiaTrust COVID-19 Ag Rapid Test |
04/16/2021 (issued) 09/01/2021 (reissued) 05/16/2022 (reissued) 08/11/2022 (revised) 11/01/2022 (revised) 11/04/2022 (revised) 01/20/2023 (revised) 03/02/2023 (revised) 07/30/2024 (revoked) |
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cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System |
09/14/2020 (issued) 09/18/2020 (revised) 11/19/2020 (revised) 12/10/2020 (revised) 05/07/2021 (revised) 05/14/2021 (revised) 06/24/2021 (revised) 09/23/2021 (revised) 01/06/2022 (revised) 03/25/2022 (revised) 08/11/2022 (revised) 10/26/2022 (revised) 02/16/2023 (revised) 06/16/2023 (revised) 07/03/2024 (revoked) |
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Accula SARS-Cov-2 Test |
03/23/2020 (issued) 04/30/2020 (revised) 08/24/2020 (revised) 01/07/2021 (reissued) 02/03/2021 (revised) 09/23/2021 (revised) 05/16/2022 (reissued) 08/77/2022 (reissued) 03/15/2023 (reissued) 05/22/2024 (revoked) |
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BD Respiratory Viral Panel for BD MAX System |
02/03/2023 (issued) 07/28/2023 (revised) 04/24/2024 (revoked) |
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FTD SARS-CoV-2 |
05/05/2020 (issued) 07/09/2020 (revised) 01/26/2021 (reissued) 04/07/2021 (revised) 09/23/2021 (revised) 01/19/2022 (revised) 04/18/2024 (revoked) |
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Bio-Rad SARS-CoV-2 ddPCR Test |
05/01/2020 (issued) 09/18/2020 (reissued) 12/09/2020 (revised) 09/23/2021 (revised) 03/15/2022 (revised) 03/27/2024 (revoked) |
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xMAP SARS-CoV-2 Multi-Antigen IgG Assay |
07/16/2020 (issued) 09/23/2021 (revised) 03/09/2022 (revised) 02/22/2024 (revoked) |
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PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit |
04/12/2021 (issued) 09/23/2021 (revised) 01/30/2024 (revoked) |
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VIDAS SARS-CoV-2 IgM |
08/06/2020 (issued) 03/11/2021 (reissued) 09/23/2021 (revised) 01/31/2024 (revoked) |
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VIDAS SARS-CoV-2 IgG |
08/06/2020 (issued) 03/11/2021 (reissued) 09/23/2021 (revised) 01/31/2024 (revoked) |
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VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack |
04/14/2020 (issued) 05/09/2020 (revised) 10/30/2020 (revised) 01/29/2021 (revised) 03/29/2021 (reissued) 09/23/2021 (revised) 02/02/2024 (revoked) |
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VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack |
04/24/2020 (issued) 05/20/2020 (revised) 10/23/2020 (revised) 02/12/2021 (reissued) 09/23/2021 (revised) 02/02/2024 (revoked) |
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TangenDx SARS-CoV-2 Molecular Test |
09/29/2023 01/17/2024 |
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Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit |
01/15/2021 05/11/2021 09/23/2021 10/25/2022 01/16/2024 |
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TaqPath COVID-19 Pooling Kit |
05/25/2021 09/23/2021 05/31/2023 01/16/2024 |
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SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay |
04/28/2023 10/05/2023 |
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Kaiser Permanente High Throughput SARS-CoV-2 Assay |
04/19/2021 09/21/2021 09/29/2023 |
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Hymon SARS-CoV-2 Test Kit |
05/22/2020 08/23/2023 |
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SARS-CoV-2 (N gene detection) Test |
05/22/2020 08/03/2020 08/28/2020 09/23/2021 08/18/2023 |
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COVID-Flu Multiplex Assay |
07/01/2021 09/23/2021 02/14/2022 08/02/2022 08/18/2023 |
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SPERA COVID-19 Ag Test |
10/12/2021 (issued) 11/01/2022 (revised) 05/22/2023 (reissued) 08/03/2023 (revoked) |
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BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) |
07/22/2021 (issued) 08/18/2021 (reissued) 07/11/2023 (revoked) |
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CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3) |
03/05/2021 (issued) 05/13/2021 (reissued) 06/15/2021 (revised) 06/03/2022 (reissued) 09/23/2021 (revised) 07/03/2023 (revoked) |
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Verily COVID-19 RT-PCR Test |
09/08/2020 12/18/2020 03/30/2021 09/23/2021 11/08/2021 11/15/2022 06/21/2023 |
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BD Veritor At-Home COVID-19 Test |
08/24/2021 11/22/2021 08/04/2022 11/01/2022 02/21/2023 06/15/2023 |
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Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test |
04/15/2021 (issued), 09/23/2021 (revised) 05/03/2022 (revised), 06/01/2023 (revoked) |
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Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test |
04/26/2022 (issued) 06/01/2023 (revoked) |
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VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System |
12/23/2022 (issued) 05/24/2023 (revoked) |
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NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay |
03/25/2021 (issued) 09/23/2021 (revised) 05/24/2023 (revoked) |
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Clip COVID Rapid Antigen Test |
12/07/2020 09/23/2021 03/04/2022 11/01/2022 05/05/2023 |
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TaqPath Monkeypox/Orthopox Virus DNA Kit |
12/13/2022 (issued) 04/18/2023 (revoked) |
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Xpert Xpress SARS-CoV-2/Flu/RSV |
09/24/2020 (issued) 10/01/2020 (reissued) 01/27/2021 (revised) 09/23/2021 (revised) 04/17/2023 (revoked) |
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Detect Covid-19 Test |
10/28/2021 (issued) 01/12/2022 (revised) 04/11/2022 (reissued) 08/17/2022 (revised) 04/14/2023 (revoked) |
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OmniPATH COVID-19 Total Antibody ELISA Test |
10/02/2020 (issued) 09/23/2021 (revised) 04/13/2023 (revoked) |
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Idylla Ebola Virus Triage Test |
05/26/2016 (issued) 03/09/2023 (revoked) |
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FilmArray NGDS BT‐E Assay |
10/25/2014 (issued) 11/22/2014 (revised) 03/02/2015 (reissued) 12/02/2015 (revised) 03/08/2023 (revoked) |
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EV-D68 2014 rRT-PCR |
05/12/2015 02/20/2023 |
Federal Register Notice: |
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Babson Diagnostics aC19G1 |
06/23/2020 09/23/2021 02/14/2023 |
Federal Register Notice: |
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SARS-CoV-2 NGS Assay |
03/23/2021 06/25/2021 09/23/2021 07/28/2022 02/14/2023 (revoked) |
Federal Register Notice: |
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Advanta Dx SARS-CoV-2 RT-PCR Assay |
08/25/2020 11/05/2020 01/08/2021 02/26/2021 02/01/2022 06/14/2022 02/01/2023 |
Federal Register Notice: |
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Advanta Dx COVID-19 EASE Assay |
02/07/2022 06/14/2022 02/01/2023 |
Federal Register Notice: |
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BinaxNOW COVID-19 Ag 2 Card |
03/31/2021 09/23/2021 01/07/2022 02/04/2022 11/01/2022 01/31/2023 |
Federal Register Notice: |
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HDPCR SARS-CoV-2 Assay |
06/09/2020 (issued) 09/12/2020 (revised) |
Federal Register Notice: |
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COVID-19 ELISA pan-Ig Antibody Test |
08/31/2020 (issued) 09/23/2021 (revised) 12/16/2022 (revoked) |
Federal Register Notice: |
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SARS-CoV-2 DETECTR Reagent Kit |
08/31/2020 (issued) 07/07/2021 (revised) 09/23/2021 (revised) 12/15/2022 (revoked) |
Federal Register Notice: |
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DETECTR BOOST SARS-CoV-2 Reagent Kit |
01/21/2022 (issued) 12/15/2022 (revoked) |
Federal Register Notice: |
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Visby Medical COVID-19 |
09/16/2020 (issued) 12/28/2020 (revised) 08/31/2021 (reissued) 12/02/2022 (revoked) |
Federal Register Notice: |
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Visby Medical COVID-19 Point of Care Test |
02/08/2021 (issued) 09/23/2021 (revised) 07/22/2022 (reissued) 12/02/2022 (revoked) |
Federal Register Notice: |
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MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay |
06/24/2020 (issued) 09/23/2021 (revised) 11/29/2021 (revised) 11/30/2022 (revoked) |
Federal Register Notice: |
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Cleveland Clinic SARS-CoV-2 Assay |
08/03/2020 (issued) 09/23/2021 (revised) 10/19/2022 (revoked) |
Federal Register Notice: |
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SelfCheck COVID-19 TaqPath Multiplex PCR |
08/09/2021 (issued) 10/19/2022 (revoked) |
Federal Register Notice: |
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Laboratorio Clinico Toledo SARS-CoV-2 Assay |
07/06/2020 12/28/2020 09/23/2021 09/21/2022 |
Federal Register Notice: |
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Talis One COVID-19 Test System |
11/05/2021 (issued) 08/23/2022 (revoked) |
Federal Register Notice: |
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BD SARS-CoV-2/Flu for BD MAX System |
02/10/2021 04/09/2021 09/23/2021 (07/29/2022; effective 08/01/2022) |
Federal Register Notice: |
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Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 |
05/28/2021 08/09/2021 12/17/2021 01/26/2022 07/19/2022 |
Federal Register Notice:
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Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test |
08/11/2021 12/17/2021 01/26/2022 07/19/2022 |
Federal Register Notice:
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Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test |
08/11/2021 12/17/2021 01/26/2022 07/19/2022 |
Federal Register Notice:
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ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit |
04/03/2020 06/05/2020 09/22/2020 06/07/2022 |
Federal Register Notice: |
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Simoa SARS-CoV-2 N Protein Antigen Test |
01/05/2021 09/10/2021 12/21/2021 05/10/2022 |
Federal Register Notice:
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Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test |
12/23/2020 04/05/2021 09/23/202 05/10/2022 |
Federal Register Notice: |
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CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay |
07/08/2020 08/31/2020 10/23/2020 12/18/2020 06/10/2021 09/23/2021 05/05/2022 |
Federal Register Notice: |
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Linea COVID-19 Assay Kit |
05/13/2020 07/08/2020 07/30/2020 11/21/2020 07/21/2021 09/23/2021 04/20/2022 |
Federal Register Notice: |
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Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit |
02/11/2021 09/23/2021 04/15/2022 |
Federal Register Notice: |
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qSanger-COVID-19 Assay |
09/04/2020 (issued) 06/23/2021 (revised) 09/23/2021 (revised) 03/10/2022 (revoked) |
Federal Register Notice: |
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Diagnovital SARS-CoV-2 Real-Time PCR Kit |
06/12/2020 (issued) 09/23/2021 (revised) 03/14/2022 (revoked) |
Federal Register Notice: |
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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) |
Federal Register Notice: |
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CentoSure SARS-CoV-2 RT-PCR Assay |
09/29/2020 (issued) 08/13/2021 (revised) 09/23/2021 (revised) 03/17/2022 (revoked) |
Federal Register Notice: |
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DiaSorin LIAISON SARS-CoV-2 IgM Assay |
09/29/2020 (issued) 09/23/2021 (revised) 03/15/2022 (revoked) |
Federal Register Notice: |
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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: |
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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: |
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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: |
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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: |
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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: |
[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: |
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Ecolab's Bioquell Technology System |
12/04/2020 (Issued) 06/30/2021 (Revoked) |
Federal Register Notices: |
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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: |
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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: |
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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: |
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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) [Archived]
- FDA in Brief: FDA Revokes Emergency Use Authorizations for Certain Respirators and Decontamination Systems as Access to N95s Increases Nationwide (06/30/2021)