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 In this section:

                Emergency Use Authorizations for Medical Devices

Emergency Use Authorizations for Medical Devices

                        


                        COVID-19 Emergency Use Authorizations for Medical Devices
          Monkeypox (mpox) Emergency Use Authorizations for Medical Devices Home
          Medical Devices
          Medical Device Safety
          Emergency Situations (Medical Devices)
          Emergency Use Authorizations for Medical Devices
          Historical Information about Device Emergency Use AuthorizationsEmergency Use Authorizations for Medical Devices Historical Information about Device Emergency Use Authorizations
  
  	
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    PrintThis page is intended to provide reference information on EUAs that were previously issued but no longer in effect, including revoked EUAs. Information about why each EUA was revoked is available in its revocation letter, available in the tables below.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 PPEInfusion Pumps

Medical Product
			Date**
			Most Recent Letter of Authorization and Other EUA-Related Information
			Fact Sheets and Manufacturer Instructions / Package InsertInfusion Pumps and Infusion Pump Accessories (umbrella)
			05/13/2020 (issued)

			09/21/2020 (revoked)
			Authorization Letter (05/13/2020) (PDF, 1.0MB)
				Revocation Letter (09/21/2020) (PDF, 106KB)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (07/14/2020)
				Revocation of Authorizations of Emergency Use of Certain Medical Devices During COVID-19; Availability (12/04/2020)
			Fact Sheet for Healthcare Providers (PDF, 759KB)
				Fact Sheet for Patients (PDF, 719KB)In Vitro Diagnostics (IVD)

Medical Product
			Date**
			Most Recent Letter of Authorization and Other EUA-Related Information
			Fact Sheets and Manufacturer Instructions / Package InsertTangenDx SARS-CoV-2 Molecular Test
			09/29/2023
			(issued)

			01/17/2024
			(revoked)
			Letter of Authorization (09/29/2023) (PDF, 821KB)
				Revocation letter (01/17/2024) (PDF, 152KB)
			Fact sheet for healthcare providers (PDF, 827KB)
				Fact sheet for Patients (PDF, 772KB)
				IFU (PDF, 8MB)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)
			Letter of authorization (01/15/2021) (PDF, 691KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (01/16/2024) (PDF, 174KB)
			Fact sheet for healthcare providers (PDF, 826KB)
				Fact sheet for Patients (PDF, 774KB)
				IFU (PDF, 7.7MB)TaqPath COVID-19 Pooling Kit
			05/25/2021
			(issued)

			09/23/2021
			(revised)

			05/31/2023
			(revised)

			01/16/2024
			(revoked)
			Letter of authorization (05/22/2020) (PDF, 954KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Letter Granting EUA Revision (05/31/2023) (PDF, 712KB)
				Revocation letter (01/16/2024) (PDF, 152KB)
			Fact sheet for healthcare providers (PDF, 869KB)
				Fact sheet for Patients (PDF, 807KB)
				IFU (PDF, 1.2MB)SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay
			04/28/2023 
			(issued)

			10/05/2023 
			(revoked)
			Letter of authorization (04/28/2023) (PDF, 895KB)
				Revocation letter (10/05/2023) (PDF, 138KB)
			Fact sheet for healthcare providers (PDF, 1.03MB)
				Fact sheet for Patients (PDF, 880KB)
				EUA Summary (PDF, 1.2MB)Kaiser Permanente High Throughput SARS-CoV-2 Assay
			04/19/2021 
			(issued)

			09/21/2021 
			(reissued)

			09/29/2023 
			(revoked)
			Letter of authorization (09/21/2022) (PDF, 1014KB)
				Revocation letter (09/29/2023) (PDF, 139KB)
			Fact sheet for healthcare providers (PDF, 813KB)
				Fact sheet for Patients (PDF, 753KB)
				EUA Summary (PDF, 1.18MB)
				IFU (Home Collect) (PDF, 2.2MB)Hymon SARS-CoV-2 Test Kit
			05/22/2020
			(issued)
			 
			08/11/2020
			(revised)

			08/23/2023
			(revoked)
			Letter of authorization (05/22/2020) (PDF, 761KB)
				Letter Granting EUA Revision (08/11/2020) (PDF, 646KB)
				Revocation letter (08/23/2023) (PDF, 140KB)
			Fact sheet for healthcare providers (PDF, 748KB)
				Fact sheet for Patients (PDF, 726KB)
				IFU (PDF, 1021KB)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)
			Letter of authorization (08/03/2020) (PDF, 756KB)
				Letter Granting EUA Revision (08/28/2020) (PDF, 709KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (08/18/2023) (PDF, 141KB)
			Fact sheet for healthcare providers (PDF, 986KB)
				Fact sheet for Patients (PDF, 916KB)
				EUA Summary (PDF, 1.41MB)
				IFU (Home Collect) (PDF, 1005KB)COVID-Flu Multiplex Assay
			07/01/2021
			(issued)

			09/23/2021
			(revised)

			02/14/2022
			(revised)

			08/02/2022
			(revised)

			08/18/2023 
			(revoked)
			Letter of authorization (07/01/2021) (PDF, 984KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Letter Granting EUA Revision (08/02/2022) (PDF, 700KB)
				Revocation letter (08/18/2023) (PDF, 140KB)
			Fact sheet for healthcare providers (PDF, 887KB)
				Fact sheet for Patients (PDF, 812KB)
				EUA Summary (PDF, 1.25MB)
				IFU (Home Collect) (PDF, 900KB)SPERA COVID-19 Ag Test
			10/12/2021 (issued)

			11/01/2022 (revised)

			05/22/2023 (reissued)

			08/03/2023 (revoked)
			Letter of authorization (05/22/2023) (PDF, 1MB)
				Repeat Testing Revision Letter (11/01/2022) (PDF, 577KB)
				Revocation letter (08/03/2023) (PDF, 151KB)
			Fact sheet for healthcare providers (PDF, 863KB)
				Fact sheet for Patients (PDF, 801KB)
				IFU (PDF, 2.4MB)BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site)
			07/22/2021 (issued)

			08/18/2021 (reissued)

			07/11/2023 (revoked)
			Letter of authorization (07/22/2021) (PDF, 884KB)
				Revocation letter (07/11/2023) (PDF, 173KB)
			Fact sheet for Healthcare Providers and Authorized Laboratories (PDF, 825KB)
				IFU (PDF, 855KB)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)
			Letter of Authorization (06/03/2022) (PDF, 286KB)
				Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2 - Amendment Letter (04/20/2021) (PDF, 366KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation Letter (07/03/2023) (PDF, 223KB)
			Fact sheet for healthcare providers (PDF, 306KB)
				Fact sheet for Patients (PDF, 247KB)
				EUA Summary (PDF, 315KB)
				IFU (Home Collect) (PDF, 772KB)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)
			Letter of authorization (11/08/2021) (PDF, 1020KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Letter Granting EUA Revision (11/15/2022) (PDF, 739KB)
				Revocation letter (06/15/2023) (PDF, 140KB)
			Fact sheet for healthcare providers (PDF, 900KB)
				Fact sheet for Patients (PDF, 822KB)
				EUA Summary (PDF, 2.7MB)
				IFU (Home Collect) (PDF, 1.55MB)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)
			Letter of authorization (11/22/2021) (PDF, 1016KB)
				Repeat Testing Revision Letter (11/01/2022) (PDF, 577KB)
				Letter Granting EUA Revision (02/21/2023) (PDF, 737KB)
				Revocation letter (06/15/2023) (PDF, 139KB)
			Fact sheet for healthcare providers (PDF, 972KB)
				Fact sheet for Patients (PDF, 827KB)
				IFU (PDF, 2.24MB)
				IFU (Home Test) (PDF, 1.84MB)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)
			Letter of authorization (04/15/2021) (PDF, 886KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (06/01/2023) (PDF, 152KB)
			Fact sheet for healthcare providers (PDF, 1.1MB)
				Fact sheet for Patients (PDF, 935KB)
				IFU (PDF, 3.5MB)Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test
			04/26/2022 (issued)

			06/01/2023 (revoked)
			Letter of authorization (12/23/2022) (PDF, 702KB)
				Revocation letter (06/01/2023) (PDF, 176KB)
			Fact sheet for healthcare providers (PDF, 866KB)
				Fact sheet for Patients (PDF, 784KB)
				IFU (PDF, 5.8MB)VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System
			12/23/2022 (issued)

			05/24/2023 (revoked)
			Letter of authorization (12/23/2022) (PDF, 928KB)
				Revocation letter (05/24/2023) (PDF, 174KB)
			Fact sheet for healthcare providers (PDF, 838KB)
				Fact sheet for Patients (PDF, 787KB)
				IFU (PDF, 1.7MB)NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay
			03/25/2021 (issued)

			09/23/2021 (revised)

			05/24/2023 (revoked)
			Letter of authorization (03/25/2021) (PDF, 704KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (05/24/2023) (PDF, 156KB)
			Fact sheet for healthcare providers (PDF, 721KB)
				Fact sheet for Patients (PDF, 705KB)
				IFU (PDF, 1.5MB)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)
			Letter of authorization (03/04/2022) (PDF, 1MB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Repeat Testing Revision Letter (11/01/2022) (PDF, 577KB)
				Revocation letter (05/05/2023) (PDF, 144KB)
			Fact sheet for healthcare providers (PDF, 708KB)
				Fact sheet for patients (PDF, 832KB)
				IFU (PDF, 6.44MB)TaqPath Monkeypox/Orthopox Virus DNA Kit
			12/13/2022 (issued)

			04/18/2023 (revoked)
			Letter of authorization (12/13/2022) (PDF, 815KB)
				Revocation letter (04/18/2023) (PDF, 153KB)
			Fact sheet for healthcare providers (PDF, 804KB)
				Fact sheet for Patients (PDF, 785KB)
				IFU (PDF, 1.4MB)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)
			Letter of authorization (10/01/2020) (PDF, 848KB)
				Letter Granting EUA Revision (01/27/2021) (PDF, 686KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (04/17/2023) (PDF, 176KB)
			Fact sheet for healthcare providers (PDF, 715KB)
				Fact sheet for Patients (PDF, 697KB)
				IFU for Labs (PDF, 1.1MB)
				IFU for Point-of-Care (PDF, 2.0MB)Detect Covid-19 Test
			10/28/2021 (issued)

			01/12/2022 (revised)

			04/11/2022 (reissued)

			08/17/2022 (revised)

			04/14/2023 (revoked)
			Letter of authorization (04/11/2022) (PDF, 983.06KB)
				Letter Granting EUA Revision (01/12/2022) (PDF, 717.27KB)
				Letter Granting EUA Revision (08/17/2022) (PDF, 702.05KB)
				Revocation letter (04/14/2023) (PDF, 143.44KB)
			Fact sheet for healthcare providers (PDF, 870.92KB)
				Fact sheet for Individuals (PDF, 832.42KB)
				IFU (PDF, 3.85KB)
				IFU (Home Test)  (PDF, 1.81KB)OmniPATH COVID-19 Total Antibody ELISA Test
			10/02/2020 (issued)

			09/23/2021 (revised)

			04/13/2023 (revoked)
			Letter of authorization (10/02/2020) (PDF, 175.56KB)”
				Viral Mutation Revision Letter (09/23/2021) (PDF, 365.75KB)
				Revocation letter (04/13/2023) (PDF, 366KB)
			Fact sheet for healthcare providers (PDF, 156.4KB)
				Fact sheet for Recipients (PDF, 143.07KB)
				IFU (PDF, 353.76KB)Idylla Ebola Virus Triage Test
			05/26/2016 (issued)

			03/09/2023 (revoked)
			Letter of Authorization (05/26/2016) (PDF, 857KB)
				Revocation Letter (03/09/2023) (PDF,  146KB)
			Fact Sheet for Healthcare Providers (PDF, 714KB)
				Fact Sheet for Patients (PDF, 695KB)
				IFU (PDF, 2.12MB)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)
			Letter of Authorization (03/02/2015) (PDF, 844KB)
				Revocation Letter (03/08/2023) (PDF, 170KB)
			Fact Sheet for Healthcare Providers(PDF, 605KB)
				Fact Sheet for Patients (PDF, 599KB)
				IFU (PDF, 3.19MB)EV-D68 2014 rRT-PCR
			05/12/2015 
			(issued)

			02/20/2023
			(terminated)
			Letter of Authorization (05/12/2015) (PDF, 836KB)***Federal Register Notice:***

			Determination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68 (February 6, 2015)
				Termination of Declaration Authorizing Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68 (February 20, 2023)
			Fact Sheet for Healthcare Providers (PDF, 797KB)
				Fact Sheet for Patients (PDF, 730KB)
				IFU (PDF, 1.29MB)Babson Diagnostics aC19G1
			06/23/2020
			(issued)

			09/23/2021
			(revised)

			02/14/2023
			(revoked)
			Letter of Authorization (02/04/2022) (PDF, 962KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation Letter (12/16/2022) (PDF, 174KB)***Federal Register Notice:***

			Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (03/09/2023)
			Fact Sheet for Healthcare Providers (PDF, 935KB)
				Fact Sheet for Recipients (PDF, 713KB)
				EUA Summary (PDF, 909KB)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)
			Letter of Authorization (07/28/2022) (PDF, 1.1MB)
				Letter Granting EUA Revision (06/25/2021) (PDF, 810KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation Letter (02/14/2023) (PDF, 174KB)***Federal Register Notice:***

			Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (03/09/2023)
			Fact Sheet for Healthcare Providers (PDF, 959KB)
				Fact Sheet for Patients (PDF, 893KB)
				IFU (PDF, 2MB)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)
			Letter of Authorization (06/14/2022) (PDF, 956KB)
				Letter Granting EUA Revision (11/05/2020) (PDF, 697KB)
				Letter Granting EUA Revision (01/08/2021) (PDF, 649KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Letter Granting EUA Revision (02/01/2022) (PDF, 794KB)
				Revocation Letter (02/01/2023) (PDF, 140KB)***Federal Register Notice:***

			Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (03/13/2023)
			Fact Sheet for Healthcare Providers (PDF, 869KB)
				Fact Sheet for Patients (PDF, 803KB)
				IFU (PDF, 3.6MB)
				IFU (Home Collection) (PDF 3.2MB)Advanta Dx COVID-19 EASE Assay
			02/07/2022 
			(issued)

			06/14/2022
			(reissued)

			02/01/2023
			(revoked)
			Letter of Authorization (06/14/2022) (PDF, 897KB)
				Revocation Letter (02/01/2023) (PDF, 139KB)***Federal Register Notice:***

			Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (03/13/2023)
			Fact Sheet for Healthcare Providers (PDF, 865KB)
				Fact Sheet for Patients (PDF, 802KB)
				IFU (PDF, 4.53MB)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)
			Letter of Authorization (02/04/2022) (PDF, 1011KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Letter Granting EUA Revision (01/07/2022) (PDF, 715KB)
				Repeat Testing Revision Letter (11/01/2022) (PDF, 366KB)
				Revocation Letter (12/16/2022) (PDF, 140KB)***Federal Register Notice:***

			Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (03/13/2023)
			Fact Sheet for Healthcare Providers (PDF, 882KB)
				Fact Sheet for Patients (PDF, 829KB)
				IFU (PDF, 1.76MB)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)
			Letter of Authorization (PDF, 939KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation Letter (PDF, 139KB)***Federal Register Notice:***

			Revocation of Four Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19 (02/01/2023)
			Fact Sheet for Healthcare Providers (PDF, 856KB)
				Fact Sheet for Patients (PDF, 787KB)
				IFU (PDF, 1.7MB)COVID-19 ELISA pan-Ig Antibody Test
			08/31/2020 (issued)

			09/23/2021 (revised)

			12/16/2022 (revoked)
			Letter of Authorization(PDF, 904KB)
				Viral Mutation Revision Letter (PDF, 366KB)
				Revocation Letter (PDF, 145KB)***Federal Register Notice:***

			Revocation of Four Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19 (02/01/2023)
			Fact Sheet for Healthcare Providers (PDF, 710KB)
				Fact Sheet for Recipients (PDF, 692KB)
				EUA Summary (PDF, 870KB)SARS-CoV-2 DETECTR Reagent Kit
			08/31/2020 (issued)

			07/07/2021 (revised)

			09/23/2021 (revised)

			12/15/2022 (revoked)
			Letter of Authorization (PDF, 854KB)
				Viral Mutation Revision Letter (PDF, 366KB)
				Revocation Letter (PDF, 144KB)***Federal Register Notice:***

			Revocation of Four Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19 (02/01/2023)
			Fact Sheet for Healthcare Providers (PDF, 702KB)
				Fact Sheet for Patients (PDF, 689KB)
				IFU (PDF, 1MB)DETECTR BOOST SARS-CoV-2 Reagent Kit
			01/21/2022 (issued)

			12/15/2022 (revoked)
			Letter of Authorization(PDF, 873KB)
				Revocation Letter (PDF, 144KB)***Federal Register Notice:***

			Revocation of Four Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19 (02/01/2023)
			Fact Sheet for Healthcare Providers (PDF, 865KB)
				Fact Sheet for Patients (PDF, 803KB)
				IFU (PDF, 1MB)Visby Medical COVID-19
			09/16/2020 (issued)

			12/28/2020 (revised)

			08/31/2021 (reissued)

			12/02/2022 (revoked)
			Letter of Authorization (08/31/2021) (PDF, 988KB)
				Revocation Letter (12/02/2022) (PDF, 144KB)***Federal Register Notice:***

			Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19 (01/03/2023)
			Fact Sheet for Healthcare Providers (PDF, 810KB)
				Fact Sheet for Patients (PDF, 752KB)
				IFU (PDF, 8MB)Visby Medical COVID-19 Point of Care Test
			02/08/2021 (issued)

			09/23/2021 (revised)

			07/22/2022 (reissued)

			12/02/2022 (revoked)
			Letter of Authorization (07/22/2022) (PDF, 901KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation Letter (12/02/2022) (PDF, 144KB)***Federal Register Notice:***

			Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19 (01/03/2023)
			Fact Sheet for Healthcare Providers(PDF, 753KB)
				Fact Sheet for Patients (PDF, 804KB)
				IFU (PDF, 1MB)
				IFU (Collect)(PDF, 1MB)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)
			Letter of Authorization (06/24/2020) (PDF, 929KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation Letter (11/30/2022) (PDF, 178KB)***Federal Register Notice:***

			Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19(01/03/2023)
			Fact Sheet for Healthcare Providers(PDF, 698KB)
				Fact Sheet for Patients (PDF, 677KB)
				EUA Summary (PDF, 1MB)Cleveland Clinic SARS-CoV-2 Assay
			08/03/2020 (issued)

			09/23/2021 (revised)

			10/19/2022 (revoked)
			Letter of Authorization (08/03/2020) (PDF, 677KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation Letter (10/19/2022) (PDF, 154KB)***Federal Register Notice:***

			Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19 (11/04/2022)
			Fact Sheet for Healthcare Providers (PDF, 714KB)
				Fact Sheet for Patients (PDF, 701KB)
				EUA Summary (PDF, 866KB)
				IFU (Home Collect) (PDF, 1.8MB)SelfCheck COVID-19 TaqPath Multiplex PCR
			08/09/2021 (issued)

			10/19/2022 (revoked)
			Letter of Authorization (08/09/2021) (PDF, 971KB)
				Revocation Letter (10/19/2022) (PDF, 154KB)***Federal Register Notice:***

			Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19 (11/04/2022)
			Fact Sheet for Healthcare Providers (PDF, 837KB)
				Fact Sheet for Patients (PDF, 775KB)
				EUA Summary (PDF, 1.1MB)
				IFU (Home Collect) (PDF, 1.8MB)Laboratorio Clinico Toledo SARS-CoV-2 Assay
			07/06/2020
			(issued)

			12/28/2020
			(revised)

			09/23/2021
			(revised)

			09/21/2022
			(reissued)
			Letter of authorization (09/21/2022) (PDF 931KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF 366KB)
				Revocation letter (09/21/2022) (PDF 139KB)***Federal Register Notice:***

			Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19 (10/11/2022)
			Fact sheet for healthcare providers (PDF 709KB)
				Fact sheet for patients (PDF 687KB)
				EUA Summary (PDF 1MB)Talis One COVID-19 Test System
			11/05/2021 (issued)

			08/23/2022 (revoked)
			Letter of authorization (11/05/2021) (PDF, 384KB)
				Revocation letter(08/23/2022) (PDF, 142KB)***Federal Register Notice:***

			Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19 (09/09/2022)
			Fact sheet for healthcare providers (PDF, 266KB)
				Fact sheet for Patients (PDF, 212KB)
				IFU (PDF, 3.1MB)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)
			Letter of authorization (02/10/2021) (PDF, 698KB)
				Letter Granting EUA Revision (04/09/2021) (PDF, 686KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (07/29/2022; effective 08/01/2022) (PDF, 145KB)***Federal Register Notice:***

			Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19 (09/09/2022)
			Fact sheet for healthcare providers(PDF, 794KB)
				Fact sheet for Patients(PDF, 748KB)
				IFU (PDF, 3.1MB)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)
			Letter of authorization (01/26/2022) (PDF, 1MB)
				Letter Granting EUA Revision (12/17/2021) (PDF, 782KB)
				Revocation letter (07/19/2022) (PDF, 146KB)***Federal Register Notice:***

			Authorization and Revocations of Emergency Use of Certain In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (for one authorization effective May 28, 2021, and three revocations effective July 19, 2022)
			Fact sheet for healthcare providers (PDF, 890KB)
				Fact sheet for individuals (PDF, 785KB)
				EUA Summary (PDF, 1.36MB)
				IFU (Home Collect) (PDF, 1MB)
				FAQ (PDF, 787KB)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)
			Letter of authorization(01/26/2022) (PDF, 1MB)
				Letter Granting EUA Revision (12/17/2021) (PDF, 782KB)
				Revocation letter (07/19/2022) (PDF, 146KB)***Federal Register Notice:***

			Authorization and Revocations of Emergency Use of Certain In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (for one authorization effective May 28, 2021, and three revocations effective July 19, 2022)
			Fact sheet for healthcare providers (PDF, 910KB)
				Fact sheet for individuals (PDF, 827KB)
				EUA Summary (PDF, 1.5MB)
				IFU (Home Collect) (PDF, 1MB)
				FAQ (PDF, 787KB)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)
			Letter of authorization (01/26/2022) (PDF, 960KB)
				Letter Granting EUA Revision (12/17/2021) (PDF, 787KB)
				Letter Granting EUA Revision (01/26/2022) (PDF, 791KB)
				Revocation letter (07/19/2022) (PDF, 146KB)***Federal Register Notice:***

			Authorization and Revocations of Emergency Use of Certain In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (for one authorization effective May 28, 2021, and three revocations effective July 19, 2022)
			Fact sheet for healthcare providers (PDF, 792KB)
				Fact sheet for patients (PDF, 752KB)
				EUA Summary (PDF, 1.42MB)
				IFU (Home Collect) (PDF, 2.48MB)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)
			Letter of authorization (04/03/2020) (PDF, 860KB)
				Letter Granting EUA Amendment (06/05/2020) (PDF, 680KB)
				Letter Granting EUA Revision (09/22/2020) (PDF, 625KB)
				Revocation letter (06/07/2022) (PDF, 860KB)***Federal Register Notice:***

			Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19 (07/15/2022)
			Fact sheet for healthcare providers(PDF, 713KB)
				Fact sheet for patients (PDF, 701KB)
				IFU (PDF, 1.1MB)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)
			Letter of authorization (12/30/2020) (PDF, 959KB)
				Revocation letter (05/10/2022) (PDF, 171KB)***Federal Register Notice:***

			Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (06/27/2022)
			Fact sheet for healthcare providers (PDF, 838KB)
				Fact sheet for patients (PDF, 806KB)
				IFU (PDF, 2.8MB)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)
			Letter of authorization (12/30/2020) (PDF, 907KB)
				Letter granting EUA revisions (04/15/2021) (PDF, 614KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (05/10/2022) (PDF, 173KB)***Federal Register Notice:***

			Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (06/27/2022)
			Fact sheet for healthcare providers (PDF, 717KB)
				Fact sheet for recipients (PDF, 702KB)
				IFU (PDF, 8.2MB)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)
			Letter of authorization (06/10/2021) (PDF, 981KB)
				Letter granting EUA revisions (08/31/2020) (PDF, 688KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (05/05/2022) (PDF, 146KB)***Federal Register Notice:***

			Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability (05/24/2022)
			Fact sheet for healthcare providers (PDF, 886KB)
				Fact sheet for patients (PDF, 820KB)
				EUA Summary (PDF, 933KB)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)
			Letter of authorization (02/11/2021) (PDF, 711KB)
				Letter granting EUA revisions (07/08/2020) (PDF, 626KB)
				Letter granting EUA revisions(07/30/2020) (PDF, 626KB)
				Letter granting EUA revisions(11/21/2020) (PDF, 627KB)
				Letter granting EUA revisions (07/21/2021) (PDF, 770KB)
				Viral Mutation Revision Letter(09/23/2021) (PDF, 366KB)
				Revocation letter (04/20/2022) (PDF, 146KB)***Federal Register Notice:***

			Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (05/09/2022)
			Fact sheet for healthcare providers (PDF, 827KB)
				Fact sheet for patients (PDF, 694KB)
				IFU (PDF, 1,134KB)Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit
			02/11/2021
			(issued)

			09/23/2021
			(revised)

			04/15/2022
			(revoked)
			Letter of authorization (02/11/2021) (PDF, 777KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (04/15/2022) (PDF, 228KB)***Federal Register Notice:***

			Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (05/09/2022)
			Fact sheet for healthcare providers (PDF, 780KB)
				Fact sheet for patients (PDF, 748KB)
				IFU (PDF, 1.97MB)qSanger-COVID-19 Assay
			09/04/2020 (issued)

			06/23/2021 (revised)

			09/23/2021 (revised)

			03/10/2022 (revoked)
			Letter of authorization (09/04/2020) (PDF, 690KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (03/10/2022) (PDF, 174KB)***Federal Register Notice:***

			Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (04/18/2022)
			Fact sheet for healthcare providers (PDF, 820KB)
				Fact sheet for patients (PDF, 768KB)
				IFU (PDF, 3.2MB)Diagnovital SARS-CoV-2 Real-Time PCR Kit
			06/12/2020 (issued)

			09/23/2021 (revised)

			03/14/2022 (revoked)
			Letter of authorization (06/12/2020) (PDF, 711KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (03/14/2022) (PDF, 182KB)***Federal Register Notice:***

			Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (04/18/2022)
			Fact sheet for healthcare providers (PDF, 711KB)
				Fact sheet for patients (PDF, 696KB)
				IFU (PDF, 1MB)CentoFast-SARS-CoV-2 RT-PCR Assay
			07/01/2020 (issued)

			08/13/2021 (revised)

			09/23/2021 (revised)

			03/17/2022 (revoked)
			Letter of authorization (07/01/2020) (PDF, 669KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (03/17/2022) (PDF, 155KB)***Federal Register Notice:***

			Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (04/18/2022)
			Fact sheet for healthcare providers (PDF, 699KB)
				Fact sheet for patients (PDF, 689KB)
				EUA summary (PDF, 915KB)CentoSure SARS-CoV-2 RT-PCR Assay
			09/29/2020 (issued)

			08/13/2021 (revised)

			09/23/2021 (revised)

			03/17/2022 (revoked)
			Letter of authorization (09/29/2020) (PDF, 664KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (03/17/2022) (PDF, 155KB)***Federal Register Notice:***

			Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (04/18/2022)
			Fact sheet for healthcare providers (PDF, 704KB)
				Fact sheet for patients (PDF, 696KB)
				EUA summary (PDF, 888KB)DiaSorin LIAISON SARS-CoV-2 IgM Assay
			09/29/2020 (issued)

			09/23/2021 (revised)

			03/15/2022 (revoked)
			Letter of authorization (09/29/2020) (PDF, 675KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (03/15/2022) (PDF, 151KB)***Federal Register Notice:***

			Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (04/18/2022)
			Fact sheet for healthcare providers (PDF, 706KB)
				Fact sheet for recipients (PDF, 690KB)
				IFU (PDF, 869KB)BinaxNOW COVID-19 Ag Card 2 Home Test
			03/31/2021 (issued)

			09/23/2021 (revised)

			01/07/2022 (revised)

			02/24/2022 (revoked)
			Letter of authorization (03/31/2021) (PDF, 836KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Letter granting EUA revisions (01/07/2022) (PDF, 685KB)
				Revocation letter (02/24/2022) (PDF, 175KB)***Federal Register Notices:***

			Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability (03/21/2022)
				Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (07/23/2021)
			Fact sheet for healthcare providers (PDF, 718KB)
				Fact sheet for individuals (PDF, 706KB)
				IFU (PDF, 1.7MB)
				IFU (Home Collect) (PDF, 4MB)Omni COVID-19 Assay by RT-PCR
			06/17/2020 (issued)

			12/28/2020 (revised)

			09/23/2021 (revised)

			02/14/2022 (revoked)
			Letter of authorization (06/17/2020) (PDF, 114KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (02/14/2022) (PDF, 226KB)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (11/20/2020)
				Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (03/14/2022)
			Fact sheet for healthcare providers (PDF, 115KB)
				Fact sheet for patients (PDF, 104KB)
				EUA summary (PDF, 518KB)LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel
			06/29/2020 (issued)

			09/23/2021 (revised)

			02/07/2022 (revoked)
			Letter of authorization (06/29/2020) (PDF, 921KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (02/07/2022) (PDF, 225KB)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (11/20/2020)
				Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (03/14/2022)
			Fact sheet for healthcare providers (PDF, 709KB)
				Fact sheet for patients (PDF, 688KB)
				EUA summary (PDF, 1.3MB)MosaiQ COVID-19 Antibody Magazine
			09/25/2020 (issued)

			04/27/2021 (revised)

			09/23/2021 (revised)

			01/11/2022 (revoked)
			Letter of authorization (09/25/2020) (PDF, 935KB)
				Letter granting EUA revisions (04/27/2021) (PDF, 694KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (01/11/2022) (PDF, 153KB)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (04/23/2021)
				Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (03/04/2022)
			Fact sheet for healthcare providers (PDF, 820KB)
				Fact sheet for patients (PDF, 780KB)
				IFU (PDF, 2.0MB)BioPlex 2200 SARS-CoV-2 IgG
			07/01/2021 (issued)

			09/23/2021 (revised)

			01/11/2022 (revoked)
			Letter of authorization (07/1/2021) (PDF, 949KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter(01/11/2022) (PDF, 173KB)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (10/28/2021)
				Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (03/04/2022)
			Fact sheet for healthcare providers (PDF, 856KB)
				Fact sheet for patients (PDF, 810KB)
				IFU (PDF, 1.1MB)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)
			Letter granting EUA revisions (12/23/2020) (PDF, 632KB)
				Reissued Letter of Authorization (04/20/2021)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (12/20/2021) (PDF, 221KB)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (04/23/2021)
				Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19(01/21/2022)
			Fact sheet for healthcare providers (PDF, 809KB)
				Fact sheet for patients (PDF, 752KB)
				IFU (PDF, 2.1MB)ADVIA Centaur SARS-CoV-2 IgG (COV2G)
			07/31/2020 (issued)

			09/23/2021 (revised)

			12/17/2021 (revoked)
			Letter of authorization (07/31/2020) (PDF, 718KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (12/17/2021) (PDF, 152KB)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (11/20/2020)
				Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19 (01/21/2022)
			Fact sheet for healthcare providers (PDF, 710KB)
				Fact sheet for recipients (PDF, 694KB)
				IFU (PDF, 1.7MB)Atellica IM SARS-CoV-2 IgG (COV2G)
			07/31/2020 (issued)

			09/23/2021 (revised)

			12/17/2021 (revoked)
			Letter of authorization (07/31/2020) (PDF, 805KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (12/10/2021) (PDF, 152KB)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (11/20/2020)
				Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19 (01/21/2022)
			Fact sheet for healthcare providers (PDF, 711KB)
				Fact sheet for recipients (PDF, 693KB)
				IFU (PDF, 1.7MB)SARS-COV-2 R-GENE
			05/06/2020 (issued)

			11/06/2020 (amended)

			09/23/2021 (revised)

			12/17/2021 (revoked)
			Letter of authorization (05/6/2020) (PDF, 991KB)
				Letter granting EUA amendment (11/06/2020) (PDF, 708KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (12/17/2021) (PDF, 174KB)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (07/14/2020)
				Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19 (01/21/2022)
			Fact sheet for healthcare providers (PDF, 735KB)
				Fact sheet for patients (PDF, 691KB)
				IFU (PDF, 1.3MB)qSARS-CoV-2 IgG/IgM Rapid Test
			04/01/2020 (issued)

			06/12/2020 (reissued)

			09/23/2021 (revised)

			12/10/2021 (revoked)
			Reissued Letter of authorization (06/12/2020) (PDF, 701KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (12/10/2021) (PDF, 242KB)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (06/05/2020)
				Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19 (01/21/2022)
			Fact sheet for healthcare providers (PDF, 138KB)
				Fact sheet for patients (PDF, 125KB)
				IFU (PDF, 325KB)BMC-CReM COVID-19 Test
			07/10/2020 (issued)

			09/25/2020 (amended)

			09/23/2021 (revised)

			12/08/2021 (revoked)
			Letter of authorization (07/10/2020) (PDF, 661KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (12/8/2021) (PDF, 228KB)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (11/20/2020)
				Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (01/13/2022)
			Fact sheet for healthcare providers (PDF, 665KB)
				Fact sheet for patients (PDF, 654KB)
				EUA summary (PDF, 680KB)Akron Children's Hospital SARS-CoV-2 Assay
			09/29/2020 (issued)

			09/23/2021 (revised)

			12/08/2021 (revoked)
			Letter of authorization (09/29/2020) (PDF, 675KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (12/8/2021) (PDF, 226KB)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (04/23/2021)
				Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (01/13/2022)
			Fact sheet for healthcare providers (PDF, 670KB)
				Fact sheet for patients (PDF, 658KB)
				EUA summary (PDF, 736KB)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)
			Letter of authorization (04/2/2020) (PDF, 712KB)
				Letter Granting EUA Amendment (05/29/2020) (PDF, 706KB)
				Viral Mutation Revision Letter (09/23/2021) (PDF, 366KB)
				Revocation letter (12/08/2021) (PDF, 227KB)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (06/5/2020)
				Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability (01/13/2022)
			Fact sheet for healthcare providers (PDF, 700KB)
				Fact sheet for patients (PDF, 771KB)
				IFU (PDF, 4.09MB)TaqPath COVID-19 MS2 Combo Kit 2.0
			08/02/2021 (issued)

			09/27/2021 (revoked)
			Letter of authorization (08/02/2021) (PDF, 1.5MB)
				Revocation letter (09/27/2021) (PDF, 218KB)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (10/28/2021)
				Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability (10/28/2021)
			Fact sheet for healthcare providers (PDF, 1.4MB)
				Fact sheet for patients (PDF, 1.3MB)
				EUA summary (PDF, 1.9MB)Guardant-19
			08/21/2020 (issued)

			12/28/2020 (amended)

			08/06/2021 (revoked)
			Letter of authorization (08/21/2020) (PDF, 727KB)
				Revocation letter (08/06/2021) (PDF, 248KB)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (11/20/2020)
				Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19 (09/24/2021)
			Fact sheet for healthcare providers (PDF, 709KB)
				Fact sheet for patients (PDF, 682KB)
				EUA summary (PDF, 1.23MB)MatMaCorp COVID-19 2SF Test
			12/17/2020 (issued)

			08/03/2021 (revoked)
			Letter of authorization (12/17/2020) (PDF, 718KB)
				Revocation letter (08/03/2021) (PDF, 245KB)***Federal Register Notices:***

			Termination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protection Devices (06/25/2010)
			[Healthcare] [Patients] [Labeling]Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR
			12/18/2009 (initial issuance)
			06/23/2010 (terminated)
			Authorization***Federal Register Notices:***

			Termination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protection Devices (06/25/2010)
			[Healthcare] [Patients] [Labeling]Focus Diagnostics SimplexaTM Influenza A H1N1 (2009) Test
			12/18/2009 (initial issuance)
			06/23/2010 (terminated)
			Authorization***Federal Register Notices:***

			Termination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protection Devices (06/25/2010)
			[Healthcare] [Patients] [Labeling]TessArray Resequencing Influenza A Microarray Detection Panel
			12/16/2009 (initial issuance)
			06/23/2010 (terminated)
			Authorization***Federal Register Notices:***

			Termination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protection Devices (06/25/2010)
			[Healthcare] [Patients] [Labeling]GeneSTAT 2009 A/H1N1 Influenza Test
			12/09/2009 (initial issuance)
			06/23/2010 (terminated)
			Authorization***Federal Register Notices:***

			Termination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protection Devices (06/25/2010)
			[Healthcare] [Patients] [Labeling]Roche RealTime ready Influenza A/H1N1 Test
			11/13/2009 (initial issuance)
			06/23/2010 (terminated)
			Authorization***Federal Register Notices:***

			Termination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protection Devices (06/25/2010)
			[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)
			Authorization***Federal Register Notices:***

			Termination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protection Devices (06/25/2010)
			[Healthcare] [Patients] [Labeling]Diatherix 2009 H1N1 Test
			10/09/2009 (initial issuance)
			06/23/2010 (terminated)
			Authorization***Federal Register Notices:***

			Termination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protection Devices (06/25/2010)
			[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)
			Authorization***Federal Register Notices:***

			Termination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protection Devices (06/25/2010)
			[Healthcare] [Patients] [Labeling]Personal Protective Equipment (PPE)

Personal Protective Equipment
			Date*
			Letter of
			Authorization
			Other DocumentsProtective Barrier Enclosures (Umbrella)
			05/01/2020 (issued)
			08/20/2020 (revoked)
			Authorization letter (05/01/2020) (PDF, 235KB)
				Revocation letter (08/20/2020) (PDF, 223KB)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (07/14/2020)
				Revocation of Authorizations of Emergency Use of Certain Medical Devices During COVID-19; Availability (12/04/2020)
				Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (03/24/2020)
				Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (02/04/2020)
			Fact Sheet for Healthcare Providers (PDF, 134KB)
				Fact Sheet for Patients (PDF, 129KB)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)
			Letter of authorization (PDF, 87KB)
				Revocation letter (06/30/2021) (PDF, 152KB)**Additional Information:**

			Revoked EUAs for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
				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)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (07/14/2020)
				Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (08/31/2021)
			Appendix A: Authorized Respirators, Non-NIOSH Respirators Manufactured in China (Updated 02/18/2021)
				Respirator Models No Longer Authorized (Updated 10/15/2020)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)
			Letter of authorization (PDF, 260KB)
				Revocation letter (06/30/2021) (PDF, 152KB)**Additional Information:**

			Revoked EUAs for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
				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)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (06/05/2020)
				Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (08/31/2021)
			Exhibit 1: Authorized Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (Updated 03/08/2021)*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
			SheetYale New Haven Health FFR Decontamination System
			01/15/2021 (Issued)

			06/30/2021 (Revoked)
			Authorization***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (04/23/2021)
				Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (08/31/2021)
			Fact Sheet for Healthcare Personnel
				Instructions for Healthcare Personnel, Healthcare Facilities, and Community Partners
				Instructions for Decontamination Personnel at Yale New Haven Health SystemEcolab's Bioquell Technology System
			12/04/2020 (Issued)

			06/30/2021 (Revoked)
			Authorization***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (04/23/2021)
				Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (08/31/2021)
			Fact Sheet for Healthcare Personnel
				Instructions for Healthcare Personnel
				[Instructions for Healthcare Facilities
				Setup Verification FormLumin LM3000 Bioburden Reduction UV System
			12/03/2020 (Issued)

			06/30/2021 (Revoked)
			Authorization***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (04/23/2021)
				Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (08/31/2021)
			Fact Sheet for Healthcare Providers
				Instructions for Healthcare Facilities
				Instructions for Healthcare PersonnelRoxby Development Zoe-Ann Decontamination System
			10/20/2020 (Issued)
			06/30/2021 (Revoked)
			Authorization***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (04/23/2021)
				Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (08/31/2021)
			Fact Sheet for Healthcare Personnel
				Instructions for Healthcare Personnel
				Instructions for Healthcare FacilitiesMichigan State University Decontamination System
			07/24/2020 (Issued)

			01/21/2021 (Reissued)

			06/30/2021 (Revoked)
			Authorization***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (11/20/2020)
				Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (08/31/2021)
			Fact Sheet for Healthcare Personnel
				Instructions for Michigan State University Staff
				Instructions for Healthcare Facilities and Operator Teams
				Instructions for Healthcare PersonnelTechnical Safety Services VHP Decontamination System
			06/13/2020 (Issued)

			01/21/2021 (Reissued)

			06/30/2021 (Revoked)
			Authorization***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (11/20/2020)
				Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (08/31/2021)
			Fact Sheet for Healthcare Personnel
				Instructions for Healthcare Facilities
				Instructions for Healthcare PersonnelStryker Sustainability Solutions VHP Decontamination System
			05/27/2020 (Issued)

			01/21/2021 (Reissued)

			06/30/2021 (Revoked)
			Authorization***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (11/20/2020)
				Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (08/31/2021)
			Fact Sheet for Healthcare Personnel
				Instructions for Healthcare Personnel and Healthcare Facilities
				Collect and Ship ProtocolSTERIS STEAM Decon Cycle in AMSCO Medium Steam Sterilizers
			05/21/2020 (Issued)

			01/21/2021 (Reissued)

			06/30/2021 (Revoked)
			Authorization***Federal Register Notices:***

			Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (08/31/2021)
			Fact Sheet for Healthcare Personnel
				Instructions for Healthcare Facilities
				Instructions for Healthcare PersonnelDuke Decontamination System
			05/07/2020 (Issued)

			01/21/2021 (Reissued)

			06/30/2021 (Revoked)
			Authorization***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (07/14/2020)
				Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (08/31/2021)
			Fact Sheet for Healthcare Personnel
				Instructions for Decontamination Facility
				Instructions for Healthcare Facilities
				Instructions for Healthcare PersonnelSterilucent, Inc. Sterilization System
			04/20/2020 (Issued)

			01/21/2021 (Reissued)

			06/30/2021 (Revoked)
			Authorization***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (07/14/2020)
				Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (08/31/2021)
			Fact Sheet for Healthcare Personnel
				Instructions for Healthcare Facilities
				Instructions for Healthcare PersonnelStryker STERIZONE VP4 N95 Respirator Decontamination Cycle
			04/15/2020 (Issued)

			01/21/2021 (Reissued)

			06/30/2021 (Revoked)
			Authorization***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (07/14/2020)
				Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (08/31/2021)
			Fact Sheet for Healthcare Personnel
				Instructions for Healthcare Facilities
				Instructions for Healthcare PersonnelAdvanced Sterilization Products (ASP) STERRAD Sterilization System
			04/11/2020 (Issued)

			01/21/2021 (Reissued)

			06/30/2021 (Revoked)
			Authorization***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (07/14/2020)
				Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (08/31/2021)
			Fact Sheet for Healthcare Personnel
				Instructions for Healthcare Facilities
				Instructions for Healthcare PersonnelSTERIS Sterilization Systems for Decontamination of N95 Respirators
			04/09/2020 (Issued)

			01/21/2021 (Reissued)

			06/30/2021 (Revoked)
			Authorization***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (06/05/2020)
				Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (08/31/2021)
			Fact Sheet for Healthcare Personnel
				Instructions for Healthcare Facilities
				Instructions for Healthcare PersonnelBattelle Decontamination System
			03/28/2020 (issued)

			03/29/2020 (reissued)

			06/06/2020 (reissued)

			01/21/2021 (reissued)

			04/30/2021 (revoked)
			Letter of authorization (PDF, 150KB)**Additional Information:**

			FDA Recommends Transition from Use of Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities (04/09/2021)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (06/05/2020)
				Revocation of Authorization of Emergency Use of a Medical Device During COVID-19; Availability (05/28/2021)
			Fact Sheet for Healthcare Personnel (PDF, 150KB)
				Instructions for Healthcare Facilities (Closed System) (PDF, 170KB)
				Instructions for Healthcare Personnel (Closed System) (PDF, 159KB)
				Instructions for Healthcare Facilities (Open System) (PDF, 123KB)
				Instructions for Healthcare Personnel (Open System) (PDF, 112KB)Nova2200 for Decontaminating Compatible N95 Respirators (NovaSterilis, Inc.)
			08/20/2020 (issued)

			02/12/2021 (revoked)
			Authorization Letter (August 20, 2020) (PDF, 258KB)
				Revocation Letter (February 12, 2021) (PDF, 172KB)***Federal Register Notices:***

			Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability (11/20/2020)
				Revocation of Authorization of Emergency Use of a Medical Device During COVID-19; Availability (04/01/2021)
			Fact Sheet for Healthcare Personnel (143KB)
				Instructions for Healthcare Facilities (176KB)
				Instructions for Healthcare Personnel (149KB)
				Instructions for Decontamination Personnel (1.13MB)* 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)

                                                                                  Content current as of:
      01/18/2024
              
              
Regulated Product(s)
		 Medical DevicesEmergency Use Authorizations for Medical Devices

          
                        


                        COVID-19 Emergency Use Authorizations for Medical Devices
          Monkeypox (mpox) Emergency Use Authorizations for Medical Devices
 
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