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  1. Emergency Use Authorizations for Medical Devices

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This page is intended to provide reference information on EUAs that were previously issued but no longer in effect, including revoked EUAs. Information about why each EUA was revoked is available in its revocation letter, available in the tables below.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

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
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)

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)

BD Respiratory Viral Panel for BD MAX System

02/03/2023 (issued)

07/28/2023 (revised)

04/24/2024 (revoked)

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)

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)

xMAP SARS-CoV-2 Multi-Antigen IgG Assay

07/16/2020 (issued)

09/23/2021 (revised)

03/09/2022 (revised)

02/22/2024 (revoked)

PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit

04/12/2021 (issued)

09/23/2021 (revised)

01/30/2024 (revoked)

VIDAS SARS-CoV-2 IgM

08/06/2020 (issued)

03/11/2021 (reissued)

09/23/2021 (revised)

01/31/2024 (revoked)

VIDAS SARS-CoV-2 IgG

08/06/2020 (issued)

03/11/2021 (reissued)

09/23/2021 (revised)

01/31/2024 (revoked)

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)

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)

TangenDx SARS-CoV-2 Molecular Test

09/29/2023
(issued)

01/17/2024
(revoked)

Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit

01/15/2021
(issued)

05/11/2021
(revised)

09/23/2021
(revised)

10/25/2022
(revised)

01/16/2024
(revoked)

TaqPath COVID-19 Pooling Kit

05/25/2021
(issued)

09/23/2021
(revised)

05/31/2023
(revised)

01/16/2024
(revoked)

SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay

04/28/2023 
(issued) 

10/05/2023 
(revoked)

Kaiser Permanente High Throughput SARS-CoV-2 Assay

04/19/2021 
(issued)

09/21/2021 
(reissued) 

09/29/2023 
(revoked)

Hymon SARS-CoV-2 Test Kit

05/22/2020
(issued)
 
08/11/2020
(revised)

08/23/2023
(revoked)

SARS-CoV-2 (N gene detection) Test

05/22/2020
(issued) 

08/03/2020 
(issued) 

08/28/2020
(revised) 

09/23/2021 
(revised) 

08/18/2023 
(revoked)

COVID-Flu Multiplex Assay

07/01/2021
(issued)

09/23/2021
(revised) 

02/14/2022
(revised) 

08/02/2022
(revised)

08/18/2023 
(revoked)

SPERA COVID-19 Ag Test

10/12/2021 (issued)

11/01/2022 (revised)

05/22/2023 (reissued)

08/03/2023 (revoked)

BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site)

07/22/2021 (issued)

08/18/2021 (reissued)

07/11/2023 (revoked)

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)

Verily COVID-19 RT-PCR Test

09/08/2020
(issued), 

12/18/2020 
(reissued)

03/30/2021 
(reissued)

09/23/2021 
(revised)

11/08/2021 
(reissued)

11/15/2022 
(revised)

06/21/2023 
(revoked)

BD Veritor At-Home COVID-19 Test

08/24/2021 
(issued), 

11/22/2021 
(reissued), 

08/04/2022 
(revised), 

11/01/2022 
(revised), 

02/21/2023 
(revised), 

06/15/2023 
(revoked)

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)

Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test

04/26/2022 (issued)

06/01/2023 (revoked)

VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System

12/23/2022 (issued)

05/24/2023 (revoked)

NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay

03/25/2021 (issued)

09/23/2021 (revised)

05/24/2023 (revoked)

Clip COVID Rapid Antigen Test

12/07/2020 
(issued) 

09/23/2021
(revised) 

03/04/2022
(reissued) 

11/01/2022
(revised) 

05/05/2023 
(revoked)

TaqPath Monkeypox/Orthopox Virus DNA Kit

12/13/2022 (issued)

04/18/2023 (revoked)

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)

Detect Covid-19 Test

10/28/2021 (issued)

01/12/2022 (revised)

04/11/2022 (reissued)

08/17/2022 (revised)

04/14/2023 (revoked)

OmniPATH COVID-19 Total Antibody ELISA Test

10/02/2020 (issued)

09/23/2021 (revised)

04/13/2023 (revoked)

Idylla Ebola Virus Triage Test

05/26/2016 (issued)

03/09/2023 (revoked)

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)

EV-D68 2014 rRT-PCR

05/12/2015 
(issued) 

02/20/2023
(terminated)

Federal Register Notice:

Babson Diagnostics aC19G1

06/23/2020
(issued)

09/23/2021
(revised)

02/14/2023
(revoked)

Federal Register Notice:

SARS-CoV-2 NGS Assay

03/23/2021
(issued)

06/25/2021
(revised)

09/23/2021
(revised)

07/28/2022
(reissued)

02/14/2023 (revoked)

Federal Register Notice:

Advanta Dx SARS-CoV-2 RT-PCR Assay

08/25/2020 
(issued) 

11/05/2020 
(revised) 

01/08/2021 
(revised)

02/26/2021 
(reissued)
 
09/23/2021
(revised) 

02/01/2022 
(revised) 

06/14/2022
(reissued) 

02/01/2023
(revoked)

Federal Register Notice:

Advanta Dx COVID-19 EASE Assay

02/07/2022 
(issued) 

06/14/2022
(reissued) 

02/01/2023
(revoked)

Federal Register Notice:

BinaxNOW COVID-19 Ag 2 Card

03/31/2021
(issued) 

09/23/2021
(revised) 

01/07/2022
(revised) 

02/04/2022
(reissued) 

11/01/2022
(revised) 

01/31/2023
(revoked)

Federal Register Notice:

HDPCR SARS-CoV-2 Assay

06/09/2020 (issued) 

09/12/2020 (revised)
 
09/23/2021 (revised)
 
02/14/2022 (reissued)
 
01/03/2023 (revoked)

Federal Register Notice:

COVID-19 ELISA pan-Ig Antibody Test

08/31/2020 (issued)

09/23/2021 (revised)

12/16/2022 (revoked)

Federal Register Notice:

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:

DETECTR BOOST SARS-CoV-2 Reagent Kit

01/21/2022 (issued)

12/15/2022 (revoked)

Federal Register Notice:

Visby Medical COVID-19

09/16/2020 (issued)

12/28/2020 (revised)

08/31/2021 (reissued)

12/02/2022 (revoked)

Federal Register Notice:

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:

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:

Cleveland Clinic SARS-CoV-2 Assay

08/03/2020 (issued)

09/23/2021 (revised)

10/19/2022 (revoked)

Federal Register Notice:

SelfCheck COVID-19 TaqPath Multiplex PCR

08/09/2021 (issued)

10/19/2022 (revoked)

Federal Register Notice:

Laboratorio Clinico Toledo SARS-CoV-2 Assay

07/06/2020
(issued)

12/28/2020
(revised)

09/23/2021
(revised)

09/21/2022
(reissued)

Federal Register Notice:

Talis One COVID-19 Test System

11/05/2021 (issued)

08/23/2022 (revoked)

Federal Register Notice:

BD SARS-CoV-2/Flu for BD MAX System

02/10/2021 
(issued)

04/09/2021 
(revised)

09/23/2021 
(revised)

(07/29/2022; effective 08/01/2022) 
(revoked)

Federal Register Notice:

Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2

05/28/2021
(issued)

08/09/2021
(reissued)

12/17/2021
(revised)

01/26/2022
(reissued)

07/19/2022
(revoked)

Federal Register Notice:

Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test

08/11/2021
(issued)

12/17/2021
(revised)

01/26/2022 
(reissued)

07/19/2022 
(revoked)

Federal Register Notice:

Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test

08/11/2021
(issued)

12/17/2021
(revised)

01/26/2022 
(reissued)

07/19/2022 
(revoked)

Federal Register Notice:

ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit

04/03/2020 
(issued)

06/05/2020
(amended)

09/22/2020 
(revised)

06/07/2022 
(revoked)

Federal Register Notice:

Simoa SARS-CoV-2 N Protein Antigen Test

01/05/2021
(issued)

09/10/2021
(re-issued)

12/21/2021
(re-issued)

05/10/2022
(revoked)

Federal Register Notice:

 

Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test

12/23/2020
(issued)

04/05/2021
(revised)

09/23/202
(revised)

05/10/2022
(revoked)

Federal Register Notice:

CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay

07/08/2020
(issued) 

08/31/2020
(revised)

10/23/2020
(re-issued) 

12/18/2020
(re-issued) 

06/10/2021
(re-issued)

09/23/2021
(revised) 

05/05/2022
(revoked)

Federal Register Notice:

Linea COVID-19 Assay Kit

05/13/2020
(issued) 

07/08/2020
(revised)

07/30/2020
(revised)

11/21/2020
(revised)

07/21/2021
(revised)

09/23/2021
(revised)

04/20/2022
(revoked)

Federal Register Notice:

Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit

02/11/2021
(issued)

09/23/2021
(revised)

04/15/2022
(revoked)

Federal Register Notice:

qSanger-COVID-19 Assay

09/04/2020 (issued)

06/23/2021 (revised)

09/23/2021 (revised)

03/10/2022 (revoked)

Federal Register Notice:

Diagnovital SARS-CoV-2 Real-Time PCR Kit

06/12/2020 (issued)

09/23/2021 (revised)

03/14/2022 (revoked)

Federal Register Notice:

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:

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:

DiaSorin LIAISON SARS-CoV-2 IgM Assay

09/29/2020 (issued)

09/23/2021 (revised)

03/15/2022 (revoked)

Federal Register Notice:

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:

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:

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:

ADVIA Centaur SARS-CoV-2 IgG (COV2G) 

07/31/2020 (issued)

09/23/2021 (revised)

12/17/2021 (revoked)

Federal Register Notices:

Atellica IM SARS-CoV-2 IgG (COV2G) 

07/31/2020 (issued)

09/23/2021 (revised)

12/17/2021 (revoked)

Federal Register Notices:

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:

BMC-CReM COVID-19 Test

07/10/2020 (issued)

09/25/2020 (amended)

09/23/2021 (revised)

12/08/2021 (revoked)

Federal Register Notices:

Akron Children's Hospital SARS-CoV-2 Assay

09/29/2020 (issued)

09/23/2021 (revised)

12/08/2021 (revoked)

Federal Register Notices:

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:

TaqPath COVID-19 MS2 Combo Kit 2.0

08/02/2021 (issued)

09/27/2021 (revoked)

Federal Register Notices:

Guardant-19

08/21/2020 (issued)

12/28/2020 (amended)

08/06/2021 (revoked)

Federal Register Notices:

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)

Personal Protective Equipment Date* Letter of
Authorization
Other Documents
Protective Barrier Enclosures (Umbrella) 05/01/2020 (issued)
08/20/2020 (revoked)

Federal Register Notices:

Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China 

04/03/2020 (issued)

05/07/2020 (reissued)

06/06/2020 (reissued)

10/15/2020 (reissued)

06/30/2021 (revoked, effective 07/06/2021)

Additional Information:

Federal Register Notices:

Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators

03/24/2020 (issued)

03/28/2020 (reissued)

06/06/2020 (reissued)

03/24/2021 (reissued)

06/30/2021 (revoked, effective 07/06/2021)

Additional Information:

Federal Register Notices:

*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:

Roxby Development Zoe-Ann Decontamination System 10/20/2020 (Issued)
06/30/2021 (Revoked)

Federal Register Notices:

Michigan State University Decontamination System

07/24/2020 (Issued)

01/21/2021 (Reissued)

06/30/2021 (Revoked)

Federal Register Notices:

Technical Safety Services VHP Decontamination System

06/13/2020 (Issued)

01/21/2021 (Reissued)

06/30/2021 (Revoked)

Federal Register Notices:

Stryker Sustainability Solutions VHP Decontamination System

05/27/2020 (Issued)

01/21/2021 (Reissued)

06/30/2021 (Revoked)

Federal Register Notices:

STERIS STEAM Decon Cycle in AMSCO Medium Steam Sterilizers

05/21/2020 (Issued)

01/21/2021 (Reissued)

06/30/2021 (Revoked)

Federal Register Notices:

Duke Decontamination System

05/07/2020 (Issued)

01/21/2021 (Reissued)

06/30/2021 (Revoked)

Federal Register Notices:

Sterilucent, Inc. Sterilization System

04/20/2020 (Issued)

01/21/2021 (Reissued)

06/30/2021 (Revoked)

Federal Register Notices:

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:

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:

 
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