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 In this section:

                COVID-19 Emergency Use Authorizations for Medical Devices

COVID-19 Emergency Use Authorizations for Medical Devices

                        Blood Purification Devices EUAs
          Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs
          In Vitro Diagnostics EUAs
          Infusion Pump EUAs
          Personal Protective Equipment EUAs
          Remote or Wearable Patient Monitoring Devices EUAs
          Respiratory Assist Devices EUAs
          Ventilators and Ventilator Accessories EUAs
          Other Medical Device EUAs Home
          Medical Devices
          Medical Device Safety
          Emergency Situations (Medical Devices)
          Emergency Use Authorizations for Medical Devices
          COVID-19 Emergency Use Authorizations for Medical Devices
          In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2COVID-19 Emergency Use Authorizations for Medical Devices In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2
  
  	
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    Print**March 24, 2023** - The FDA has finalized two guidances: *Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency* and *Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)*. The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for:

Developing a transition implementation plan,
	Submitting a marketing submission, and
	Taking other actions with respect to these devices.The FDA encourages stakeholders to review the two final guidances, view the webinar, and reach out to the FDA if they have questions or concerns. In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.

Additional Resources:

Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
	Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
	Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023


**In Vitro Diagnostic EUAs: Overview and Templates**

Templates and Other Information
	Antigen Diagnostic Tests for SARS-CoV-2
	Other Tests for SARS-CoV-2
	Serology and Other Adaptive Immune Response Tests for SARS-CoV-2
	IVDs for Management of COVID-19 Patients


On This Page:

Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2
	Revision Concerning Viral Mutation
	Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2
	Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing
	EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity TestsIndividual EUAs for Molecular Diagnostic Tests for SARS-CoV-2

The table below includes information about authorized SARS-CoV-2 molecular diagnostic tests. These emergency use authorizations (EUAs) have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. Test attributes are listed in the "Attributes" column. For example, tests authorized for the screening of asymptomatic individuals without known exposure are listed with "screening" in the attribute column; pooling, multi-analyte, saliva, home collection, and home testing are similarly listed. Tests available without a prescription include the attribute "DTC" (for direct-to-consumer home collection tests) or "OTC" (for over-the-counter at-home tests). To see additional authorization documents, such as letters granting EUA amendments or revisions, and a list of other brand names authorized under a specific EUA, select the plus (+) button beside the "Date EUA Issued or Last Updated" for the EUA.

For information on test EUAs that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD).

In addition to COVID-19 tests issued EUAs, there are molecular SARS-CoV-2 diagnostic tests that have been authorized through traditional premarket review pathways.


Tests with "single target" in the attribute column are:

designed to detect only one viral target on the SARS-CoV-2 genome;
	more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants.Tests with "multiple targets" in the attribute column are:

designed to detect two or more viral targets, or sections of the SARS-CoV-2 genome;
	more likely to continue to perform well when new variants emerge.EUAs for standalone specimen collection devices, including home collection kits which do not include an assay in the EUA, will not have a target designation in the attribute column.

Authorized Molecular Diagnostic Tests for SARS-CoV-2 are assigned the QJR product code.

Authorized Home Collection Kits are assigned the QLW product code. Authorized EUAs for Multi-analyte Respiratory Panel Tests are assigned the QLT product code.

Date EUA Issued or Last Updated
			Entity
			Diagnostic (Most Recent Letter of Authorization) and Date EUA Original Issue
			Attributes3
			Authorized Setting(s)1
			Authorization Documents2
			Other Documents
			Other Brand Name(s)09/19/2023
			3EO Health, Inc.
			3EO Health COVID-19 Test 09/19/2023
			RT, LAMP, Over the Counter (OTC) Home Testing, Multiple Targets
			Home, H, M, W
			HCP, Individuals, IFU, IFU Home
			None
			None06/08/2023
			Michigan State University laboratories, Department of Medicine Olin Student Health Center
			In-Dx SARS-CoV-2 RT-LAMP Assay 06/08/2023
			RT-LAMP, Single Target
			H
			HCP, Patients, EUA Summary
			None
			None06/05/2023
			Acutis Diagnostics
			SARS-CoV-2 Acutis Multiplex Assay 06/05/2023
			real-time RT-PCR, Multiple Targets
			H
			HCP, Patient, EUA Summary
			None
			None04/26/2023
			University of Massachusetts
			ICTC SARS-CoV-2 RT-PCR Assay 4/26/2023
			real-time RT-PCR, Multiple Targets
			H
			HCP, Patient, EUA Summary
			None
			None11/08/2022
			Nanobiosym Precision Testing Services
			The Nano Test for COVID-19 11/08/2022
			Real-time RT-PCR, Home Collection, Saliva, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU
			None
			None07/18/2023
			Aptitude Medical Systems Inc.
			Metrix COVID-19 Test 10/18/2022
			RT, LAMP, Over the Counter (OTC) Home Testing, Saliva, Screening, Multiple Targets
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (February 10, 2023)
				Letter Granting EUA Revision(s) (July 18, 2023)
			None09/13/2022
			Predicine, Inc.
			Predicine SARS-CoV-2 RT-PCR Test 07/19/2022
			Real-time RT-PCR, Home Collection, Multiple Targets, Screening, Pooling
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			None
			None07/28/2022
			Laboratory Corporation of America (Labcorp)
			Labcorp Seasonal Respiratory Virus RT-PCR DTC Test 05/16/2022
			Direct to Consumer (DTC), Real-time RT-PCR, Multi-analyte, Home Collection, Single Target
			H
			HCP, Individuals, EUA Summary, IFU (Home Collect)
			Letter Granting EUA Revision(s) (July 28, 2022)
			None04/26/2022
			Audere
			HealthPulse@home Fusion 04/26/2022
			Home Collection Kit, Screening, Single Target
			N/A
			EUA Summary, IFU
			None
			None12/17/2021
			UCSD BCG EXCITE Lab
			UCSD EXCITE COVID-19 Test12/17/2021
			Real-time RT-PCR, Home Collection, Screening, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			None
			None08/24/2022
			Applied BioCode, Inc.
			BioCode CoV-2 Flu Plus Assay
			12/15/2021
			RT-PCR, Multi-analyte, Single Target
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (August 24, 2022)
			None07/21/2022
			Meridian Bioscience, Inc.
			Revogene SARS-CoV-2
			11/09/2021
			Real time RT-PCR, Single Target
			H, M
			HCP, Patients, IFU
			None
			None07/21/2022
			PerkinElmer, Inc.
			PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1
			10/06/2021
			Real-time RT-PCR, Multi-analyte, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (December 14, 2021)
				Letter Granting EUA Revision(s) (January 21, 2022)
				Letter Granting EUA Revision(s) (July 21, 2022)
			None10/19/2022
			Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute
			SelfCheck cobas SARS-CoV-2 Assay
			09/29/2021
			Real-time RT-PCR, Home Collection, Screening, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			None
			None12/14/2021
			Quest Diagnostics Nichols Institute
			Quest Diagnostics Collection Kit for COVID-19
			10/08/2021
			Home Collection Kit
			N/A
			EUA Summary, IFU
			None
			None07/28/2022
			Laboratory Corporation of America (Labcorp)
			Labcorp SARS-CoV-2 & Influenza A/B Assay
			9/30/2021
			Real-time RT-PCR, Multi-analyte, Home Collection, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Letter Granting EUA Revision(s) (July 28, 2022)
			None07/18/2023
			Cepheid
			Xpert Xpress CoV-2/Flu/RSV plus 09/10/2021
			Real-time RT-PCR, Multi-analyte, Multiple Targets
			H, M, W
			HCP, Patients, IFU for Labs,IFU for Point-of-Care
			Letter Granting EUA Revision(s) (October 20, 2021)
				Letter Granting EUA Revision(s) (July 18, 2023)
			None04/21/2023
			Yale School of Public Health, Department of Epidemiology of Microbial Diseases
			SalivaDirect for use with DTC Kits 08/27/2021
			Direct to Consumer (DTC), Real-time RT-PCR, Saliva, Home Collection, Screening, Pooling, Single Target
			H
			HCP, Individuals, EUA Summary
			Letter Granting EUA Revision(s) (December 14, 2022)
				Letter Granting EUA Revision(s) (April 21, 2023)
			None12/01/2022
			Yale School of Public Health, Department of Epidemiology of Microbial Diseases
			SalivaDirect DTC Saliva Collection Kit
			08/27/2021
			Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening
			N/A
			Individual,IFU-1, IFU-2, EUA Summary
			None
			None08/25/2021
			Empire City Laboratories
			ECL COVID TEST SYSTEM-1 08/25/2021
			Real-time RT-PCR, Home Collection, Multiple Targets
			H
			HCP, Patients, IFU (Home Collect), EUA Summary
			None
			None08/25/2021
			Empire City Laboratories
			ECL COVID TEST SYSTEM 08/25/2021
			Real-time RT-PCR, Home Collection, Multiple Targets
			H
			HCP, Patients,IFU (Home Collect), EUA Summary
			None
			None08/23/2021
			The Mount Sinai Hospital, Center for Clinical Laboratories
			Mount Sinai SARS-CoV-2 Assay 08/23/2021
			Real-time RT-PCR, Home Collection, Saliva, Screening, Multiple Targets
			H
			HCP, Patients, IFU (Home Collect), EUA Summary
			None
			None01/11/2022
			SEASUN BIOMATERIALS
			U-TOP COVID-19 Detection Kit
			04/27/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (September 1, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None03/30/2023
			SD Biosensor, Inc.
			STANDARD M nCoV Real-Time Detection Kit
			04/23/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (March 30, 2023)
			None11/15/2022
			altona Diagnostics GmbH
			RealStar SARS-CoV02 RT-PCR Kits U.S.
			04/22/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None03/07/2023
			Centers for Disease Control and Prevention's (CDC)
			CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC)
			02/04/2020
			Real-time RT-PCR, Pooling, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (March 30, 2020)
				Letter Granting EUA Amendment(s) (June 12, 2020)
				Letter Granting EUA Amendment(s) (July 13, 2020)
				Letter Granting EUA Revision(s) (July 21, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None05/20/2021
			Wadsworth Center, New York State Department of Public Health
			New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel
			02/29/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (March 15, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None04/26/2022
			BGI Genomics Co. Ltd
			Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2
			03/26/2020
			Real-time RT-PCR, Single Target
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (April 24, 2020)
				Letter Granting EUA Revision(s) (March 29, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None04/26/2022
			Cepheid
			Xpert Xpress SARS-CoV-2 test
			03/20/2020
			Real-time RT-PCR, Multiple Targets
			H, M, W
			HCP, Patients, IFU for Labs,IFU for Point-of-Care
			Letter Granting EUA Amendment(s) (April 28, 2020)
				Letter Granting EUA Amendment(s) (August 8, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None01/05/2021
			Primerdesign Ltd.
			Primerdesign Ltd COVID-19 genesig Real-Time PCR assay
			03/20/2020
			Real-time RT-PCR, Single Target
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (April 8, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None08/18/2020
			GenMark Diagnostics, Inc.
			ePlex SARS-CoV-2 Test
			03/19/2020
			RT-PCR and electrochemical detection, Multiple Targets
			H, M
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (August 18, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None07/22/2021
			DiaSorin Molecular LLC
			Simplexa COVID-19 Direct assay
			03/19/2020
			Real-time RT-PCR, Multiple Targets
			H, M
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (March 26, 2020)
				Letter Granting EUA Amendment(s) (April 13, 2020)
				Letter Granting EUA Amendment(s) (June 4, 2020)
			None06/28/2022
			Abbott Molecular Inc.
			Abbott RealTime SARS-CoV-2 assay
			03/18/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (April 1, 2020)
				Letter Granting EUA Amendment(s) (July 30, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None03/10/2023
			Quest Diagnostics Nichols Institute
			Quest SARS-CoV-2 rRT-PCR
			03/17/2020
			Real-time RT-PCR, Home Collection, Pooling, Multiple Targets, Screening (Anterior Nasal)
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (March 26, 2020)
				Letter Granting EUA Amendment(s) (July 28, 2020)
				Letter Granting EUA Revision(s) (November 13, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None04/17/2023
			Quidel Corporation
			Lyra SARS-CoV-2 Assay
			03/17/2020
			Real-time RT-PCR, Single Target
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (April 8, 2020)
				Letter Granting EUA Revision(s) (April 21, 2021)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (September 16, 2022)
				Letter Granting EUA Revision(s) (April 17, 2023)
			None06/21/2022
			Laboratory Corporation of America (Labcorp)
			COVID-19 RT-PCR Test
			03/16/2020
			Real-time RT-PCR, Home Collection, Pooling, Screening, Multiple Targets
			H
			HCP, Patients, EUA
			Summary, IFU (Home Collect)
			Letter Granting EUA Amendment(s) (April 14, 2020)
				Letter Granting EUA Amendment(s) (July 1, 2020)
				Letter Granting EUA Revision(s) (May 11, 2021)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (April 7, 2022)
			None03/23/2022
			Hologic, Inc.
			Panther Fusion SARS-CoV-2 Assay
			03/16/2020
			Real-time RT-PCR, Pooling, Screening, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (April 24, 2020)
				Letter Granting EUA Revision(s) (January 22, 2021)
			None08/31/2022
			Thermo Fisher Scientific, Inc.
			TaqPath COVID-19 Combo Kit
			03/13/2020
			Real-time RT-PCR, Home Collection, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (March 24, 2020)
				Letter Granting EUA Amendment(s) (April 20, 2020)
				Letter Granting EUA Amendment(s) (May 9, 2020)
				Letter Granting EUA Amendment(s) (July 17, 2020)
				Letter Granting EUA Revision(s) (November 20, 2020)
				Letter Granting EUA Revision(s) (February 23, 2021)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (August 31, 2022)
			None02/08/2023
			Roche Molecular Systems, Inc. (RMS)
			cobas SARS-CoV-2
			03/12/2020
			Real-time RT-PCR, Pooling, Screening, Multiple Targets
			H, M, H-Pooling
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (March 31, 2020)
				Letter Granting EUA Amendment(s) (May 13, 2020)
				Letter Granting EUA Revision(s) (May 14, 2021)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (February 8, 2023)
			None03/15/2023
			Mesa Biotech Inc.
			Accula SARS-Cov-2 Test
			03/23/2020
			RT and amplification, Single Target
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (April 30, 2020)
				Letter Granting EUA Revision(s) (August 24, 2020)
				Letter Granting EUA Revision(s) (February 3, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None05/31/2022
			BioFire Defense, LLC
			BioFire COVID-19 Test
			03/23/2020
			RT, Nested multiplex PCR, Pooling, Saliva, Multiple Targets
			H, M
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (April 30, 2020)
				Letter Granting EUA Revision(s) (March 7, 2022)
				Letter Granting EUA Revision(s) (May 31, 2022)
			None03/23/2023
			PerkinElmer, Inc.
			PerkinElmer New Coronavirus Nucleic Acid Detection Kit
			03/24/2020
			Real-time RT-PCR, Pooling, Saliva, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (April 1, 2020)
				Letter Granting EUA Revision(s) (April 1, 2021)
				Letter Granting EUA Revision(s) (December 10, 2021)
				Letter Granting EUA Revision(s) (February 2, 2022)
				Letter Granting EUA Revision(s) (September 12, 2022)
			None10/04/2022
			Avellino Lab USA, Inc.
			AvellinoCoV2 test
			03/25/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Letter Granting EUA Revision(s) (September 24, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None10/19/2022
			Luminex Molecular Diagnostics, Inc.
			NxTAG CoV Extended Panel Assay
			03/27/2020
			RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None08/27/2021
			Abbott Diagnostics Scarborough, Inc.
			ID NOW COVID-19
			03/27/2020
			RT, Isothermal amplification, Single Target
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (April 21, 2020)
			None07/29/2021
			QIAGEN GmbH
			QIAstat-Dx Respiratory SARS-CoV-2 Panel
			03/30/2020
			Real-time RT-PCR, Multi-analyte, Multiple Targets
			H, M
			HCP, Patients, IFU
			None
			None01/22/2021
			NeuMoDx Molecular, Inc.
			NeuMoDx SARS-CoV-2 Assay
			03/30/2020
			RT-PCR, Collection Kit, Saliva, Multiple Targets
			H, M
			HCP, Patients, IFU, IFU (Collect)
			Letter Granting EUA Amendment(s) (April 23, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None03/15/2023
			Ipsum Diagnostics, LLC
			COV-19 IDx assay
			04/01/2020
			Real-time RT-PCR, Single Target
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None03/14/2023
			Co-Diagnostics, Inc.
			Logix Smart Coronavirus Disease 2019 (COVID-19) Kit
			04/03/2020
			RT-PCR, CoPrimer technology, Single Target
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (March 14, 2023)
			None03/27/2023
			Luminex Corporation
			ARIES SARS-CoV-2 Assay
			04/03/2020
			RT-PCR, Multiple Targets
			H, M
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (May 11, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None04/28/2020
			Gnomegen LLC
			Gnomegen COVID-19 RT-Digital PCR Detection Kit
			04/06/2020
			Real-time RT-digital PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (April 28, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None05/21/2021
			InBios International, Inc
			Smart Detect SARS-CoV-2 rRT-PCR Kit
			04/07/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (June 3, 2020)
				Letter Granting EUA Amendment(s) (August 10, 2020)
				Letter Granting EUA Revision(s) (August 24, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None01/11/2022
			DiaCarta, Inc
			QuantiVirus SARS-CoV-2 Test kit
			04/08/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None07/14/2022
			Becton, Dickinson and Company (BD)
			BD SARS-CoV-2 Reagents for BD MAX System
			04/08/2020
			Real-time RT-PCR, Screening, Multiple Targets
			H, M
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (June 11, 2020)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (July 14, 2022)
			None12/28/2020
			Atila BioSystems, Inc.
			iAMP COVID-19 Detection Kit
			04/10/2020
			RT, Isothermal amplification, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (July 18, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None03/09/2023
			Maccura Biotechnology (USA) LLC
			SARS-CoV-2 Fluorescent PCR Kit
			04/15/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (June 2, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None04/16/2020
			GenoSensor, LLC
			GS"¢ COVID-19 RT-PCR KIT
			04/16/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None02/15/2023
			Fosun Pharma USA Inc.
			Fosun COVID-19 RT-PCR Detection Kit
			04/17/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None02/24/2023
			OSANG Healthcare
			GeneFinder COVID-19 Plus RealAmp Kit
			04/18/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (June 24, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None08/08/2020
			Trax Management Services Inc.
			PhoenixDx 2019-CoV
			04/20/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendments (May 11, 2020)
				Letter Granting EUA Amendment(s) (August 8, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None12/13/2022
			Seegene, Inc.
			Allplex 2019-nCoV Assay
			04/21/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (July 27, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None03/01/2023
			LabGenomics Co., Ltd.
			LabGun COVID-19 RT-PCR Kit
			04/29/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None09/13/2022
			Rheonix, Inc.
			Rheonix COVID-19 MDx Assay
			04/29/2020
			RT-PCR, Home Collection, Saliva, Single Target
			H, M
			HCP, Patients, IFU, IFU (Home Collect)
			Viral Mutation Revision Letter - September 23, 2021
			None03/15/2022
			Bio-Rad Laboratories, Inc
			Bio-Rad SARS-CoV-2 ddPCR Test
			05/01/2020
			RT-droplet PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (December 9, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None03/25/2022
			Sansure BioTech Inc.
			Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
			05/04/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) 
				(March 25, 2022)
			None01/19/2022
			Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company)
			FTD SARS-CoV-2
			05/05/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (July 9, 2020)
				Letter Granting EUA Revision(s) (April 7, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None11/01/2022
			OPTI Medical Systems, Inc.
			OPTI SARS-CoV-2 RT PCR Test
			05/06/2020
			Real-time RT-PCR, Screening, Pooling, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (May 29, 2020)
				Letter Granting EUA Amendment(s) (July 29, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None02/18/2022
			Sherlock BioSciences, Inc.
			Sherlock CRISPR SARS-CoV-2 Kit
			05/06/2020
			RT-LAMP, CRISPR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None08/18/2021
			Infinity BiologiX LLC
			Infinity BiologiX TaqPath SARS-CoV-2 Assay
			04/10/2020
			Real-time RT-PCR, Home Collection, Saliva, Pooling, Multiple Targets
			H
			HCP, Patients, IFU (Home Collect), EUA Summary
			Letter Granting EUA Revision(s) (March 11, 2021)
				Letter Granting EUA Revision(s) (November 30, 2020)
			Vault Health COVID-19 Test
				USGC Saliva Test Kit, hims/hers Saliva Test Kit
				BioIQ COVID-19 Saliva Test
				Concentric by Ginkgo
				1health.io Zero Contact
				Base10 Saliva Test Kit
				Purlab. Saliva Test Kit
				Reliant Saliva Test Kit
				E7 Health Saliva Test Kit
				miinehealth Saliva Test Kit
				Maverick Saliva Test Kit
				SDTL Saliva Test Kit
				AZOVA At-Home COVID-19 Test Collection Kit
				Wellness 4 Humanity SDNA-1000 Saliva Collection Kit02/14/2022
			Zymo Research Corporation
			Quick SARS-CoV-2rRT-PCR Kit
			05/07/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (May, 18, 2020)
				Letter Granting EUA Amendment(s) (May 28, 2020)
				Letter Granting EUA Revision(s) (December 30, 2020)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (February 14, 2022)
			None05/08/2020
			Gnomegen LLC
			Gnomegen COVID-19-RT-qPCR Detection Kit
			05/08/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None12/09/2022
			1drop Inc.
			1copy COVID-19 qPCR Multi Kit
			05/11/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (December 9, 2022)
			None06/28/2022
			Abbott Molecular Inc.
			Alinity m SARS-CoV-2 assay
			05/11/2020
			Real-time RT-PCR, Pooling, Screening, Multiple Targets
			H, M
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (July 20, 2020)
				Letter Granting EUA Revision(s) (August 24, 2020)
			None08/30/2023
			Hologic, Inc.
			Aptima SARS-CoV-2 assay
			05/14/2020
			TMA, chemiluminescent, Pooling, Screening, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (July 24, 2020)
				Letter Granting EUA Revision(s) (September 15, 2020)
				Letter Granting EUA Revision(s) (January 22, 2021)
				Letter Granting EUA Revision(s) (March 26, 2021)
			None10/12/2022
			GeneMatrix, Inc.
			NeoPlex COVID-19 Detection Kit
			05/14/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (January 26, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None06/22/2021
			Fulgent Therapeutics
			Fulgent COVID-19 by RT-PCR Test
			05/15/2020
			Real-time RT-PCR, Home Collection, Screening, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Letter Granting EUA Amendment(s) (June 15, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None03/02/2023
			Everlywell, Inc.
			Everlywell COVID-19 Test Home Collection Kit
			05/15/2020
			Home Collection Kit
			N/A
			IFU, EUA Summary
			Letter Granting EUA Revision(s) (September 4, 2020)
			None02/23/2022
			Assurance Scientific Laboratories
			Assurance SARS-CoV-2 Panel
			05/15/2020
			Real-time RT-PCR, Home Collection, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None05/25/2021
			Quidel Corporation
			Lyra Direct SARS-CoV-2 Assay
			05/18/2020
			Real-time RT-PCR, Single Target
			H
			HCP, Patients,IFU
			Letter Granting EUA Revision(s) (January 26, 2021)
				Letter Granting EUA Revision(s) (May 25, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None04/01/2021
			P23 Labs, LLC.
			P23 Labs TaqPath SARS-CoV-2 Assay
			05/21/2020
			Real-time RT-PCR, Home Collection, Saliva, Multiple Targets
			H
			HCP, Patients, IFU1 (Home Collect), IFU2 (Home Collect)  EUA Summary
			Letter Granting EUA Amendment(s) (June 17, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			AZOVA P23 At-Home COVID-19 Test Collection Kit
				binx health (powered by P23) At-home Saliva COVID-19 Test Collection Kit for the Group Setting01/05/2022
			Seasun Biomaterials, Inc.
			AQ-TOP COVID-19 Rapid Detection Kit
			05/21/2020
			RT-LAMP, Single Target
			H
			HCP, Patients,IFU
			Viral Mutation Revision Letter - September 23, 2021
			None12/28/2020
			SolGent Co., Ltd
			DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit
			05/21/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP,Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None08/18/2021
			INVITES BIOCORE CO., LTD.
			BioCore 2019-nCoV Real Time PCR Kit
			05/21/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients,IFU
			Viral Mutation Revision Letter - September 23, 2021
			None02/01/2022
			LetsGetChecked, Inc.
			LetsGetChecked Coronavirus (COVID-19) Test
			05/28/2020
			Direct to Consumer (DTC), TMA, chemiluminescent, Home Collection, Screening, Pooling, Multiple Targets
			H
			HCP, Individuals, EUA Summary, IFU (Home Collect)
			Letter Granting EUA Amendment(s) (July 6, 2020)
				Letter Granting EUA Revision(s) (November 1, 2021)
			None05/17/2021
			Phosphorus Diagnostics LLC
			Phosphorus COVID-19 RT-qPCR Test
			06/04/2020
			Real-time RT-PCR, Home Collection, Saliva, Screening, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect), IFU (Clinic)
			Letter Granting EUA Amendment(s) (June 24, 2020)
				Letter Granting EUA Revision(s) (March 1, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			Wheeler Labs COVID-19 RT-qPCR Test03/03/2023
			Genetron Health (Beijing) Co., Ltd.
			Genetron SARS-CoV-2 RNA Test
			06/05/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None04/13/2022
			Euroimmun US, Inc.
			EURORealTime SARS-Cov-2
			06/08/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (April 22, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None01/19/2022
			Illumina, Inc.
			Illumina COVIDSeq Test
			06/09/2020
			Sequencing, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (August 20, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None05/12/2023
			DTPM, Inc.
			DTPM COVID-19 RT-PCR Test
			06/10/2020
			Real-time RT-PCR, Single Target
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None08/27/2021
			TBG Biotechnology Corp.
			ExProbe SARS-CoV-2 Testing Kit
			06/10/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (January 6, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None03/01/2022
			Cue Health Inc.
			Cue COVID-19 Test
			06/10/2020
			RT, Isothermal amplification, Screening, Single Target
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (August 20, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None06/08/2021
			Applied BioCode, Inc.
			BioCode SARS-CoV-2 Assay
			06/15/2020
			RT-PCR, Pooling, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (October 22, 2020)
				Letter Granting EUA Revision(s) (June 8, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None01/13/2022
			Kaiser Permanente Mid-Atlantic States
			KPMAS COVID-19 Test
			06/13/2020
			Real-time RT-PCR, Home Collection, Screening, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Viral Mutation Revision Letter - September 23, 2021
			None05/10/2021
			Jiangsu Bioperfectus Technologies Co., Ltd.
			COVID-19 Coronavirus Real Time PCR Kit
			06/18/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (December 29, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None06/17/2020
			The Ohio State University Wexner Medical Center
			OSUWMC COVID-19 RT-PCR test
			06/17/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None06/24/2021
			3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.
			TRUPCR SARS-CoV-2 Kit
			06/18/2020
			Real-time RT-PCR, Saliva, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (July 21, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None09/21/2020
			HealthQuest Esoterics
			HealthQuest Esoterics TaqPath SARS-CoV-2 Assay
			06/23/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None06/23/2020
			University of Alabama at Birmingham Fungal Reference Lab
			FRL SARS CoV-2 Test
			06/23/2020
			Real-time RT-PCR, Single Target
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None08/26/2021
			Gencurix, Inc.
			GenePro SARS-CoV-2 Test
			06/23/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			None
			None01/29/2021
			Diagnostic Solutions Laboratory, LLC
			DSL COVID-19 Assay
			06/25/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None01/06/2022
			PreciGenome LLC
			FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR)
			06/25/2020
			RT-digital droplet PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None04/26/2022
			PlexBio Co., Ltd.
			IntelliPlex SARS-CoV-2 Detection Kit
			06/25/2020
			RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (February 3, 2021)
			None06/26/2020
			Inform Diagnostics, Inc.
			Inform Diagnostics SARS-CoV-2 RT-PCR Assay
			06/26/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None09/24/2020
			Acupath Laboratories, Inc.
			Acupath COVID-19 Real-Time (RT-PCR) Assay
			06/29/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None01/26/2022
			Psomagen, Inc.
			Psoma COVID-19 RT Test
			06/30/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (January 26, 2022)
			None05/28/2021
			BioTNS Co. Ltd.
			COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit
			06/30/2020
			RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None05/19/2021
			The Kroger Co.
			Kroger Health COVID-19 Test Home Collection Kit
			06/30/2020
			Home Collection Kit, Direct to Consumer (DTC), Screening
			N/A
			Individuals, IFU, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None08/05/2021
			Centers for Disease Control and Prevention (CDC)
			Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay
			07/02/2020
			Real-time RT-PCR, Multi-analyte, Single Target
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (November 20, 2020)
				Letter Granting EUA Revision(s) (January 8, 2021)
			None02/13/2023
			Enzo Life Sciences, Inc.
			AMPIPROBE SARS-CoV-2 Test System
			07/07/2020
			Real-time RT-PCR, Pooling, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (July 16, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None02/05/2021
			Access Bio, Inc.
			CareStart COVID-19 MDx RT-PCR
			07/07/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (February 09, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			KarmaCare COVID-19 MDx RT-PCR
				AQGene COVID-19 MDx RT-PCRv12/28/2020
			Gene By Gene
			Gene By Gene SARS-CoV-2 Detection Test
			07/07/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None07/09/2020
			UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin
			SARS-CoV-2 RNA DETECTR Assay
			07/09/2020
			RT-LAMP, Single Target
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None12/28/2020
			BioSewoom, Inc.
			Real-Q 2019-nCoV Detection Kit
			07/09/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None01/04/2022
			KogeneBiotech Co., Ltd.
			PowerChek 2019-nCoV Real-time PCR Kit
			07/13/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			None
			None11/01/2022
			Trax Management Services Inc.
			PhoenixDx SARS-CoV-2 Multiplex
			07/13/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (August 8, 2020)
				Letter Granting EUA Revision(s) (November 20, 2020)
				Letter Granting EUA Revision(s) (April 7, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None07/13/2020
			Compass Laboratory Services, LLC
			Compass Laboratory Services SARS-CoV2 Assay
			07/13/2020
			Real-time RT-PCR, Home Collection, Single Target
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None03/10/2023
			Quest Diagnostics Nichols Institute
			Quest Diagnostics PF SARS-CoV-2 Assay
			07/15/2020
			Real-time RT-PCR, Home Collection, Multiple Targets, Screening
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None03/10/2023
			Quest Diagnostics Nichols Institute
			Quest Diagnostics RC SARS-CoV-2 Assay
			07/15/2020
			Real-time RT-PCR, Home Collection, Pooling, Multiple Targets, Screening
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None12/14/2021
			Quest Diagnostics Nichols Institute
			Quest Diagnostics HA SARS-CoV-2 Assay
			07/15/2020
			TMA, chemiluminescent, Home Collection, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None09/21/2020
			Boston Heart Diagnostics
			Boston Heart COVID-19 RT-PCR Test
			07/16/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Letter Granting EUA Revision(s) (September 2, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None07/28/2021
			Access Genetics, LLC
			OraRisk COVID-19 RT-PCR
			07/17/2020
			Real-time RT-PCR, Home Collection, Single Target
			H
			HCP, Patients, EUA Summary
			None
			None01/20/2022
			DiaCarta, Inc.
			QuantiVirus SARS-CoV-2 Multiplex Test Kit
			07/21/2020
			Real-time RT-PCR, Single Target
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None10/22/2020
			Helix OpCo LLC
			Helix COVID-19 Test
			07/23/2020
			Real-time RT-PCR, Home Collection, Screening, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Viral Mutation Revision Letter - September 23, 2021
			None07/24/2020
			Jiangsu CoWin Biotech Co., Ltd.
			Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)
			07/24/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None07/09/2021
			Color Health, Inc.
			Color SARS-CoV-2 RT-LAMP Diagnostic Assay
			05/18/2020
			RT, LAMP, Home Collection, Screening, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Letter Granting EUA Revision(s) (August 28, 2020)
				Letter Granting EUA Revision(s) (July 9, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None09/21/2020
			Eli Lilly and Company
			Lilly SARS-CoV-2 Assay
			07/27/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Letter Granting EUA Revision(s) (September 21, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None01/29/2021
			Sandia National Laboratories
			SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay
			07/27/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None07/30/2020
			Clinical Reference Laboratory, Inc.
			CRL Rapid Response
			07/30/2020
			Real-time RT-PCR, Home Collection, Saliva, Single Target
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Viral Mutation Revision Letter - September 23, 2021
			None02/27/2023
			Xiamen Zeesan Biotech Co., Ltd.
			SARS-CoV-2 Test Kit (Real-time PCR)
			07/31/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (November 10, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None07/31/2020
			University of California San Diego Health
			UCSD RC SARS-CoV-2 Assay
			07/31/2020
			Real-time RT-PCR, Pooling, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None06/17/2021
			WREN Laboratories LLC
			WREN Laboratories COVID-19 PCR Test
			08/03/2020
			Real-time RT-PCR, Home Collection, Saliva, Screening, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Viral Mutation Revision Letter - September 23, 2021
			None09/21/2020
			Ethos Laboratories
			Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay
			08/03/2020
			RT-PCR and MALDI-TOF Mass Spec., Home Collection, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Letter Granting EUA Revision(s) (August 11, 2020)
				Letter Granting EUA Revision(s) (September 18, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None08/03/2020
			Poplar Healthcare
			Poplar SARS-CoV-2 TMA Pooling assay
			08/03/2020
			TMA, chemiluminescent, Pooling, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None07/14/2021
			ISPM Labs, LLC dba Capstone Healthcare
			Genus SARS-CoV-2 Assay
			08/03/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			None
			None08/06/2020
			Helix OpCo LLC (dba Helix)
			Helix COVID-19 NGS Test
			08/06/2020
			Sequencing, Single Target
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None06/24/2021
			Vela Operations Singapore Pte Ltd
			ViroKey SARS-CoV-2 RT-PCR Test
			08/05/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
				Viral Mutation Revision Letter - September 23, 2021
			None01/06/2022
			George Washington University Public Health Laboratory
			GWU SARS-CoV-2 RT-PCR Test
			08/07/2020
			Real-time RT-PCR, Multiple Targets, Home Collection
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Viral Mutation Revision Letter - September 23, 2021
			None12/28/2020
			Solaris Diagnostics
			Solaris Multiplex SARS-CoV-2 Assay
			08/10/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None01/28/2021
			Alpha Genomix Laboratories
			Alpha Genomix TaqPath SARS-CoV-2 Combo Assay
			08/10/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None03/24/2023
			Biomeme, Inc.
			Biomeme SARS-CoV-2 Real-Time RT-PCR Test
			08/11/2020
			Real-time RT-PCR, Pooled Serial Screening - Swab, Pooled Serial Screening - Media, Multiple Targets
			H
			HCP, Patient, IFU
			Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2 - Amendment Letter
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) April, 5, 2022
			None07/18/2023
			LumiraDx UK Ltd.
			LumiraDx SARS-CoV-2 RNA STAR
			08/11/2020
			RT, non-isothermal nucleic acid amplification qSTAR, Single Target
			H
			HCP, Patient, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None05/28/2021
			Pro-Lab Diagnostics
			Pro-AmpRT SARS-CoV-2 Test
			08/13/2020
			RT, Isothermal amplification, Single Target
			H
			HCP, Patient, EUA Summary
			Letter Granting EUA Revision(s) (May 28, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None04/21/2023
			Yale School of Public Health, Department of Epidemiology of Microbial Diseases
			SalivaDirect
			08/15/2020
			Real-time RT-PCR, Saliva, Home Collection, Screening, Pooling, Single Target
			H
			HCP, Patients, EUA Summary
			Letter Granting EUA Revision(s) (August 25, 2020)
				Letter Granting EUA  Revision(s) (October 15, 2020)
				Letter Granting EUA Revision(s) (February 5, 2021)
				Letter Granting EUA Revision(s) (March 12, 2021)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (April 21, 2023)
			None08/17/2020
			ZhuHai Sinochips Bioscience Co., Ltd.
			COVID-19 Nucleic Acid RT-PCR Test Kit
			08/17/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None12/09/2020
			DxTerity Diagnostics, Inc.
			DxTerity SARS-CoV-2 RT-PCR Test
			08/21/2020
			Real-time RT-PCR, Saliva, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Letter Granting EUA Revision(s) (December 9, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None06/14/2023
			Texas Department of State Health Services, Laboratory Services Section
			Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay
			08/21/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (June 14, 2023)
			None02/08/2021
			QDx Pathology Services
			QDX SARS-CoV-2 Assay
			08/25/2020
			Real-time RT-PCR, Home Collection, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Letter Granting EUA Revision(s) (February 8, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None10/02/2020
			Cuur Diagnostics
			Cuur Diagnostics SARS-CoV-2 Molecular Assay
			08/26/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None09/21/2020
			Patients Choice Laboratories, LLC
			PCL SARS-CoV-2 Real-Time RT-PCR Assay
			08/28/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None02/17/2023
			DxTerity Diagnostics, Inc.
			DxTerity SARS-CoV-2 RT PCR CE Test
			08/28/2020
			RT-PCR, Home Collection, Saliva, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Letter Granting EUA Revision(s) (March 29, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None12/28/2020
			T2 Biosystems, Inc.
			T2SARS-CoV-2 Panel
			08/31/2020
			RT, amplification, T2 Magnetic resonance, Single Target
			H, M
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None05/27/2022
			MiraDx
			MiraDx SARS-CoV-2 RT-PCR assay
			08/31/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None01/28/2021
			BayCare Laboratories, LLC
			BayCare SARS-CoV-2 RT PCR Assay
			08/31/2020
			Real-time RT-PCR, Pooling, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None06/17/2021
			MobileDetect Bio Inc.
			MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit
			09/01/2020
			RT-LAMP, Multiple Targets
			H, M
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None12/28/2020
			OPTOLANE Technologies, Inc.
			Kaira 2019-nCoV Detection Kit
			09/01/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None07/21/2022
			Color Health, Inc.
			Color COVID-19 Self-Swab Collection Kit
			08/31/2020
			Home Collection Kit, Screening, Multiple Targets
			N/A
			EUA Summary, IFU
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (January 26, 2022)
				Letter Granting EUA Revision(s) (July 21, 2022)
			None03/31/2023
			Bioeksen R&D Technologies Inc.
			Bio-Speedy Direct RT-qPCR SARS-CoV-2
			09/02/2020
			Real-time RT-PCR, Single Target
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (December 9, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			BioeXsen SARS-CoV-2 RT PCR02/10/2023
			Roche Molecular Systems, Inc.
			cobas SARS-CoV-2 & Influenza A/B
			09/03/2020
			Real-time RT-PCR, Multi-analyte, Multiple Targets
			H, M
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (December 15, 2020)
				Letter Granting EUA Revision(s) (June 8, 2021)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA [VB,R3] Revision(s) (February 10, 2023)
			None10/31/2020
			Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
			Wantai SARS-CoV-2 RT-PCR Kit
			09/09/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (October 31, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None06/16/2023
			Roche Molecular Systems, Inc.
			cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System
			09/14/2020
			Real-time RT-PCR, Multi-analyte, Multiple Targets
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (September 18, 2020)
				Letter Granting EUA Revision(s) (December 10, 2020)
				Letter Granting EUA Revision(s) (June 24, 2021)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (January 6, 2022)
				Letter Granting EUA Revision(s) (August 11, 2022)
				Letter Granting EUA Revision(s) (October 26, 2022)
				Letter Granting EUA Revision(s) (February 16, 2023)
			None08/27/2021
			GK Pharmaceuticals Contract Manufacturing Operations
			GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT
			09/18/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None07/15/2021
			KimForest Enterprise Co., Ltd.
			KimForest SARS-CoV-2 Detection Kit v1
			09/21/2020
			Real-time RT-PCR, Single Target
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None05/06/2021
			Quadrant Biosciences Inc.
			Clarifi COVID-19 Test Kit
			09/22/2020
			Real-time RT-PCR, Saliva, Pooling, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None06/12/2023
			Vela Operations Singapore Pte. Ltd.
			ViroKey SARS-CoV-2 RT-PCR Test v2.0
			09/22/2020
			Real-time RT-PCR, Multiple Targets, Pooled Serial Screening – Media
			H
			HCP, Patients, IFU
			Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2 – Amendment Letter
				Letter Granting EUA Revision(s) (June 12, 2023)
			None03/24/2022
			Clear Labs, Inc.
			Clear Dx SARS-CoV-2 Test
			09/23/2020
			RT-PCR and Sequencing, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None02/16/2023
			Genetrack Biolabs, Inc.
			Genetrack SARS-CoV-2 Molecular Assay
			09/25/2020
			Real-time RT-PCR, Home Collection, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Letter Granting EUA Revision(s) (October 17, 2020)
				Viral Mutation Revision Letter - September 23, 2021
			None11/19/2021
			Aeon Global Health
			Aeon Global Health SARS-CoV-2 Assay
			09/30/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None01/28/2022
			National Jewish Health
			SARS-CoV-2 MassArray Test
			09/29/2020
			RT-PCR and MALDI-TOF Mass Spec. , Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (January 21, 2022)
			None04/02/2021
			Alimetrix, Inc.
			Alimetrix SARS-CoV-2 RT-PCR Assay
			09/30/2020
			RT-PCR, Microarray Hybridization, Home Collection, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Viral Mutation Revision Letter - September 23, 2021
			None03/18/2022
			Tempus Labs, Inc.
			iC SARS-CoV2 Test
			10/01/2020
			Real-time RT-PCR, Home Collection, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Viral Mutation Revision Letter - September 23, 2021
			None12/28/2020
			UMass Memorial Medical Center
			UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel
			10/01/2020
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None06/05/2023
			BioFire Diagnostics, LLC
			BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ)
			10/02/2020
			RT, Nested multiplex PCR, Multi-analyte, Multiple Targets
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (December 22, 2020)
				Letter Granting EUA Revision(s) (April 27, 2021)
				Letter Granting EUA Revision(s) (April 26, 2022)
				Letter Granting EUA Revision(s) (June 5, 2023)
			None01/11/2022
			SEASUN BIOMATERIALS, Inc.
			AQ-TOP COVID-19 Rapid Detection Kit PLUS
			10/05/2020
			RT-LAMP, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None10/08/2020
			University of California, Los Angeles (UCLA)
			UCLA SwabSeq COVID-19 Diagnostic Platform
			10/06/2020
			RT-PCR and Sequencing, Single Target
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None07/06/2023
			GenMark Diagnostics, Inc.
			ePlex Respiratory Pathogen Panel 2
			10/07/2020
			RT-PCR and electrochemical detection, Multi-analyte, Multiple Targets
			H, M
			HCP, Patients, IFU
			None
			None08/04/2021
			Spectrum Solutions LLC
			SDNA-1000 Saliva Collection Device
			10/08/2020
			Saliva Collection Device
			N/A
			EUA Summary, IFU
			None
			None07/10/2023
			LumiraDx UK Ltd.
			LumiraDx SARS-CoV-2 RNA STAR Complete
			10/14/2020
			RT, qSTAR amplification, Home Collection, Screening, Pooling, Single Target
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (March 22, 2021)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (August 17, 2022)
				Letter Granting EUA Revision(s) (September 15, 2022)
				Letter Granting EUA Revision(s) (February 22, 2023)
			None06/10/2021
			Clinical Enterprise, Inc.
			EmpowerDX COVID-19 Home Collection Kit DTC
			10/15/2020
			Home Collection Kit, Direct to Consumer (DTC), Screening
			N/A
			EUA Summary, Individuals, IFU
			None
			None01/12/2022
			Viracor Eurofins Clinical Diagnostics
			Viracor SARS-CoV-2 assay
			04/06/2020
			Real-Time RT-PCR, Pooling, Screening, Pooled Serial Screening - Swab, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2 - Amendment Letter
				Viral Mutation Revision Letter - September 23, 2021
			None08/13/2021
			binx health, Inc.
			binx health At-Home Nasal Swab COVID-19 Sample Collection Kit
			10/20/2020
			Home Collection Kit
			N/A
			EUA Summary, IFU
			Letter Granting EUA Revision(s) (August 13, 2021)
			None05/04/2021
			Agena Bioscience, Inc.
			MassARRAY SARS-CoV-2 Panel
			10/26/2020
			RT-PCR, chip array and MALDI-TOF Mass Spec, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (November 30, 2020)
				Letter Granting EUA Revision(s) (January 27, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None10/28/2020
			DNA Genotek Inc.
			ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100 saliva collection devices
			10/28/2020
			Saliva Collection Device
			N/A
			EUA Summary, IFU
			None
			None10/28/2020
			DNA Genotek Inc.
			OMNIgene·ORAL OM-505 and OME-505 (OMNIgene·ORAL) saliva collection devices
			10/14/2020
			Saliva Collection Device
			N/A
			EUA Summary, IFU
			None
			None06/14/2023
			Pfizer Inc.
			Lucira COVID-19 All-In-One Test Kit
			11/17/2020
			Prescription Home Testing, Multiple Targets
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (July 28, 2022)
			None01/22/2021
			Express Gene LLC, DBA: Express Gene Molecular Diagnostics Laboratory
			Express Gene 2019-nCoV RT-PCR Diagnostic Panel
			05/22/2020
			Real-time RT-PCR, Collection Kit, Saliva, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None03/03/2022
			Diversified Medical Healthcare
			RapidRona Self-Collection Kit
			11/23/2020
			Home Collection Kit, Screening
			N/A
			EUA Summary, IFU (Collection)
			Viral Mutation Revision Letter - September 23, 2021
			None10/15/2021
			Gravity Diagnostics, LLC
			Gravity Diagnostics SARS-CoV-2 RT-PCR Assay
			11/23/2020
			Real-time RT-PCR, Home Collection, Saliva, Screening, Multiple Targets
			H
			HCP, Patients, EUA Summary
			None
			None11/24/2020
			Stanford Health Care Clinical Virology Laboratory
			SARS-CoV-2 RT-PCR Assay
			04/08/2020
			Real-time RT-PCR, Home Collection, Single Target
			H
			HCP, Patients, EUA Summary, IFU (Home Collection)
			Viral Mutation Revision Letter - September 23, 2021
			None12/14/2021
			Quest Diagnostics Nichols Institute
			Quest Diagnostics RC COVID-19+Flu RT-PCR
			12/04/2020
			Real-time RT-PCR, Multi-analyte, Home Collection, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collection)
			Viral Mutation Revision Letter - September 23, 2021
			None11/01/2022
			Laboratory Corporation of America (LabCorp)
			Pixel by LabCorp COVID-19 Test Home Collection Kit
			12/09/2020
			Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening, Multiple Targets
			H
			HCP, Individuals, EUA Summary, IFU (Home Collect)
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (April 1, 2022)
				Letter Granting EUA Revision(s) (July 8, 2022)
				Letter Granting EUA Revision(s) (November 1, 2022)
			None08/12/2022
			RCA Laboratory Services LLC dba GENETWORx
			GENETWORx Covid-19 Nasal Swab Test
			12/15/2020
			Real-time RT-PCR, Home Collection, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Letter Granting EUA Revision(s) (February 12, 2021)
				Letter Granting EUA Revision(s) (May 14, 2021)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (November 17, 2021)
			None12/11/2020
			ResearchDx, Inc., DBA Pacific Diagnostics
			PacificDx Covid-19
			12/11/2020
			TMA, chemiluminescent, Home Collection, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None02/14/2023
			Hologic, Inc.
			Aptima SARS-CoV-2/Flu assay
			12/16/2020
			Real-time TMA, chemiluminescent, Multi-analyte, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (February 24, 2021)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (February 14, 2023)
			None05/05/2022
			Quidel Corporation
			Solana SARS-CoV-2 Assay
			12/23/2020
			Isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA), Single Target
			H, M
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (March 9, 2021)
				Letter Granting EUA Revision(s) (March 25, 2021)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (May 5, 2022)
			None10/11/2022
			Cepheid
			Xpert Xpress SARS-CoV-2 DoD
			12/23/2020
			Real-time RT-PCR, Pooling, Multiple Targets
			H, M, W
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None06/08/2022
			SML GENETREE Co., Ltd.
			Ezplex SARS-CoV-2 G Kit
			01/13/2021
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (April 30, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None07/16/2021
			Ambry Genetics Laboratory
			Ambry COVID-19 RT-PCR Test
			01/22/2021
			Real-time RT-PCR, Home Collection, Saliva, Multiple Targets
			H
			HCP, Patients, IFU (Home Collect), EUA Summary
			Letter Granting EUA Revision(s) (March 3, 2021)
				Letter Granting EUA Revision(s) (July 16, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None01/19/2021
			Hospital of the University of Pennsylvania
			BD MAX COVID-19 ASSAY (Authorized by HHS/OASH)
			01/19/2021
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None09/06/2022
			INNO Diagnostics Reference Laboratory, Ponce Medical School
			PMSF-INNO SARS-CoV-2 RT-PCR Test (Authorized by HHS/OASH)
			01/19/2021
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None06/24/2021
			Clinomics USA Inc.
			Clinomics TrioDx RT-PCR COVID-19 Test
			02/04/2021
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None03/20/2023
			Thermo Fisher Scientific
			TaqPath COVID-19, FluA, FluB Combo Kit
			02/10/2021
			Real-time RT-PCR, Multi-analyte, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (March 4, 2022)
				Letter Granting EUA Revision(s) (March 20, 2023)
			None07/07/2022
			Grifols Diagnostic Solutions Inc.
			Procleix SARS-CoV-2 Assay
			02/10/2021
			TMA, Single Target
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
			None08/07/2022
			Gravity Diagnostics, LLC
			Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits
			02/13/2021
			Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Multiple Targets
			H
			HCP, Individuals, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None02/23/2022
			Assurance Scientific Laboratories
			Assurance SARS-CoV-2 Panel DTC
			02/13/2021
			Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Single Target
			H
			HCP, Individuals, EUA Summary, IFU (Home Collect)
			None
			binx/Assurance Covid-19 Collection Kit03/02/2023
			Everlywell, Inc.
			Everlywell COVID-19 Test Home Collection Kit DTC
			02/13/2021
			Home Collection Kit, Direct to Consumer (DTC), Screening
			N/A
			Individuals, EUA Summary, IFU (Home Collect)
			None
			None01/14/2022
			University of Illinois Office of the Vice President for Economic Development and Innovation
			covidSHIELD
			02/24/2021
			Real-time RT-PCR, Saliva, Serial Screening, Home Collection, Pooling, Multiple Targets
			H
			HCP, Patients, EUA Summary IFU (Home Collect)
			None
			None01/19/2022
			Viracor Eurofins Clinical Diagnostics
			Viracor SARS-CoV-2 assay DTC
			02/26/2021
			Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Multiple Targets
			H
			HCP, Individuals, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None04/29/2022
			Cue Health Inc.
			Cue COVID-19 Test for Home and Over The Counter (OTC) Use
			03/05/2021
			RT, Isothermal amplification, Over the Counter (OTC) Home Testing, Screening, Single Target
			Home, H, M, W
			HCP, Individuals, IFU, IFU (Home Test), FAQ
			Viral Mutation Revision Letter - September 23, 2021
			None06/28/2022
			Abbott Molecular Inc.
			Alinity m Resp-4-Plex
			03/04/2021
			Real-time RT-PCR, Multi-analyte, Multiple Targets
			H, M
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (June 10, 2021)
				Letter Granting EUA Revision(s) (July 1, 2021)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (February 7, 2022)
				Letter Granting EUA Revision(s) (March 30, 2022)
			None01/04/2023
			Luminex Molecular Diagnostics, Inc.
			NxTAG Respiratory Pathogen Panel + SARS-CoV-2
			03/03/2021
			RT-PCR, Multi-analyte, Multiple Targets
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (January 4, 2023)
			None08/07/2022
			Gravity Diagnostics, LLC
			Gravity Diagnostics COVID-19 Test Home Collection Kit
			03/09/2021
			Home Collection Kit, Direct to Consumer (DTC), Screening
			N/A
			EUA Summary, Individuals, IFU
			None
			None01/26/2022
			Color Health, Inc.
			Color COVID-19 Self-Swab Collection Kit DTC
			03/19/2021
			Home Collection Kit, Direct to Consumer (DTC), Screening
			N/A
			EUA Summary, Individuals, IFU
			Letter Granting EUA Revision(s) (January 26, 2022)
			None09/03/2021
			Color Health, Inc.
			Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC
			03/19/2021
			Direct to Consumer (DTC), RT, LAMP, Home Collection, Screening, Multiple Targets
			H
			EUA Summary, Individuals, HCP
			None
			None01/26/2022
			STS Lab Holdco (a subsidiary of Amazon.com Services LLC)
			Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2
			03/25/2021
			Real-time RT-PCR, Home Collection, Pooling, Screening, Single Target
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (December 17, 2021)
				Letter Granting EUA Revision(s) (January 26, 2022)
			None08/31/2022
			University of Louisville Infectious Diseases Laboratory
			SARS-CoV-2 real time RT-PCR test (Authorized by HHS/OASH)
			01/19/2021
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None06/29/2023
			Pfizer Inc.
			Lucira CHECK-IT COVID-19 Test Kit
			04/09/2021
			RT, LAMP, Over the Counter (OTC) Home Testing, Screening, Multiple Targets
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (July 28, 2022)
			None11/04/2022
			Thermo Fisher Scientific Inc.
			Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit
			04/09/2021
			Real-time RT-PCR, Saliva, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (March 3, 2022)
				Letter Granting EUA Revision(s) (November 4, 2022)
			None04/12/2021
			PerkinElmer Genomics
			PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit
			04/12/2021
			Real-time RT-PCR, Home Collection, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None06/24/2021
			Clinical Enterprise, Inc.
			Clinical Enterprise SARS-CoV-2 RT-PCR Assay
			04/13/2021
			Real-time RT-PCR, Screening, Pooled Serial Screening - Swab, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2 - Amendment Letter
				Viral Mutation Revision Letter - September 23, 2021
			None04/13/2021
			Clinical Enterprise, Inc.
			Clinical Enterprise SARS-CoV-2 RT-PCR Assay DTC
			04/13/2021
			Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Multiple Targets
			H
			HCP, Individuals, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None12/01/2022
			Yale School of Public Health, Department of Epidemiology of Microbial Diseases
			SalivaDirect At-Home Collection Kit
			04/09/2021
			Home Collection Kit, Saliva, Screening
			N/A
			EUA Summary, IFU-1, IFU-2
			Letter Granting EUA Revision(s) (May 6, 2021)
			None06/15/2022
			Color Health, Inc.
			Color COVID-19 Self-Swab Collection Kit with Saline
			04/14/2021
			Home Collection Kit, Screening
			N/A
			EUA Summary, IFU
			Letter Granting EUA Revision(s) (January 31, 2022)
				Letter Granting EUA Revision(s) (June 15, 2022)
			None06/02/2021
			Synergy Diagnostic Laboratory, Inc., DBA SynergyDx
			SynergyDx SARS-CoV-2 RNA Test DTC
			04/16/2021
			Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Multiple Targets
			H
			HCP, Individuals, EUA Summary, IFU (Home Collect)
			Letter Granting EUA Revision(s) (June 2, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None06/02/2021
			Synergy Diagnostic Laboratory, Inc., DBA SynergyDx
			SynergyDx SARS-CoV-2 RNA Test
			04/16/2021
			Real-time RT-PCR, Home Collection, Screening, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Letter Granting EUA Revision(s) (June 2, 2021)
				Viral Mutation Revision Letter - September 23, 2021
			None07/22/2021
			PathogenDx, Inc.
			DetectX-Rv
			04/20/2021
			RT-PCR, DNA Microarray Hybridization, Multiple Targets
			H
			HCP, Patients, IFU
			None
			None05/17/2021
			Phosphorus Diagnostics LLC
			Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC
			05/17/2021
			Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening, Multiple Targets
			N/A
			Individual, EUA Summary, IFU
			None
			None05/17/2021
			Phosphorus Diagnostics LLC
			Phosphorous COVID19 RT-qPCR Test DTC
			05/17/2021
			Real-time RT-PCR, Direct to Consumer (DTC), Screening, Salvia, Home Collection, Multiple Targets
			H
			HCP, Individuals, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None07/08/2021
			Harvard University Clinical Laboratory (HUCL)
			Quaeris SARS-CoV-2 Assay
			05/21/2021
			Real-time RT-PCR, Home Collection, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			None
			None06/17/2021
			WREN Laboratories LLC
			WREN Laboratories COVID-19 PCR Test DTC
			06/17/2021
			Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Saliva Screening, Multiple Targets
			H
			HCP, Individuals, EUA Summary
			Viral Mutation Revision Letter - September 23, 2021
			None06/17/2021
			WREN Laboratories LLC
			WREN Laboratories COVID-19 Saliva Test Collection Kit DTC
			06/17/2021
			Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening, Multiple Targets
			N/A
			Individuals, EUA Summary, IFU
			None
			None08/02/2023
			Roche Molecular Systems
			cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2)
			06/17/2021
			Real-time RT-PCR, Screening, Multiple Targets
			H, M, W
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (August 11, 2022)
				Letter Granting EUA Revision(s) (October 26, 2022)
				Letter Granting EUA Revision(s) (February 16, 2023)
				Letter Granting EUA Revision(s) (May 18, 2023)
			None11/01/2022
			BioGX, Inc.
			BioGX Xfree COVID-19 Direct RT-PCR
			06/29/2021
			Real-time RT-PCR, Single Target
			H
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (November 1, 2022)
			None07/01/2021
			Everlywell, Inc.
			Everlywell COVID-19 & Flu Test Home Collection Kit
			07/01/2021
			Home Collection Kit, Multi-analyte
			N/A
			IFU, EUA Summary
			None
			None03/31/2023
			Thermo Fisher Scientific Inc.
			TaqPath COVID-19 RNase P Combo Kit 2.0
			07/08/2021
			Real-time RT-PCR, Screening, Home Collection, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (March 1, 2022)
				Letter Granting EUA Revision(s) (September 21, 2022)
				Letter Granting EUA Revision(s) (March 31, 2023)
			None03/20/2023
			Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.)
			TaqPath COVID-19 Fast PCR Combo Kit 2.0
			07/30/2021
			Real-time RT-PCR, Saliva, Multiple Targets
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (October 22, 2021)
				Letter Granting EUA Revision(s) (March 20, 2023)
			None11/29/2021
			Kwokman Diagnostics, LLC
			Kwokman Diagnostics COVID-19 Home Collection Kit
			08/13/2021
			Home Collection Kit
			N/A
			IFU, EUA Summary
			None
			None09/22/2021
			Life Sciences Testing Center
			Life Sciences Testing Center COVID-19 Test
			09/22/2021
			Real-time RT-PCR, Home Collection, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			None
			None10/14/2021
			LMSI, LLC (dba Lighthouse Lab Services)
			CovidNow SARS-CoV-2 Assay
			10/14/2021
			Real-time RT-PCR, Home Collection, Screening, Single Target
			H
			HCP, Patients, IFU, IFU (Home Collect)
			None
			None07/19/2022
			Audere
			HealthPulse@home
			11/30/2021
			Home Collection Kit, Screening, Single Target
			N/A
			EUA Summary, IFU
			None
			None04/21/2022
			Premier Medical Laboratory Services
			PMLS SARS-CoV-2 Assay
			01/07/2022
			Real-time RT-PCR, Home Collection, Screening, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			None
			None01/25/2024
			Uh-Oh Labs Inc.
			UOL COVID-19 Test
			02/08/2022
			RT-LAMP, Single Target
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s)  (March 25, 2022)
				Letter Granting EUA Revision(s) (August 2, 2022)
				Letter Granting EUA Revision(s) (September 9, 2022)
				Letter Granting EUA Revision(s) (November 8, 2022)
				Letter Granting EUA Revision(s) (July 6, 2023)
				Letter Granting EUA Revision(s) (January 25, 2024)
			None07/28/2022
			Minute Molecular Diagnostics, Inc.
			DASH SARS-CoV-2/S Test
			03/15/2022
			Real-time RT-PCR, Multiple Targets
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (July 28, 2022)
			None07/14/2022
			Helix OpCo LLC (dba Helix)
			Helix SARS-CoV-2 Test
			03/17/2022
			Real-time RT-PCR, Home Collection, Multiple Targets, Screening
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			None
			None07/07/2022
			Quest Diagnostics Nichols Institute
			Quest COVID-19 PCR Test Home Collection Kit
			03/21/2022
			Direct to Consumer (DTC), Home Collection Kit, Screening
			N/A
			EUA Summary, IFU, Individuals
			Letter Granting EUA Revision(s) (July 7, 2022)
			None03/21/2022
			Quest Diagnostics Nichols Institute
			Quest RC COVID-19 PCR DTC
			03/21/2022
			Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Multiple Targets, Screening
			H
			HCP, Individuals, EUA Summary
			None
			None03/21/2022
			Quest Diagnostics Nichols Institute
			Quest PF COVID-19 PCR DTC
			03/21/2022
			Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Multiple Targets, Screening
			H
			HCP, Individuals, EUA Summary
			None
			None10/06/2022
			Quest Diagnostics Nichols Institute
			Quest COVID-19 PCR DTC
			03/21/2022
			Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Multiple Targets, Screening
			H
			HCP, Individuals, EUA Summary
			Letter Granting EUA Revision(s) (October 6, 2022)
			None04/06/2022
			DC Department of Health
			Test Yourself DC At-Home COVID-19 Collection Kit 04/06/2022
			Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening, Multiple Targets
			H
			HCP, Individuals, EUA Summary, IFU (Home Collect)
			None
			None05/25/2022
			UCSD BCG EXCITE Lab
			UCSD EXCITE COVID-19 EL Test04/07/2022
			Real-time RT-PCR, Home Collection, Screening, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Letter Granting EUA Revision(s) (May 25, 2022)
			None08/17/2022
			Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute
			SelfCheck cobas SARS-CoV-2 + Flu Assay 04/11/2022
			Real-time RT-PCR, Home Collection, Multi-analyte, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Letter Granting EUA Revision(s) (August 17, 2022)
			None08/24/2022
			MicroGEM U.S., Inc.
			MicroGEM Sal6830 SARS-CoV-2 Saliva Test
			04/14/2022
			Real-time RT-PCR, Saliva, Multiple Targets
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (August 24, 2022)
			None04/21/2022
			OPTI Medical Systems, Inc.
			OPTI SARS-CoV-2/ Influenza A/B RT-PCR Test (Version 1 and Version 2)
			04/21/2022
			Real-time RT-PCR, Multi-analyte, Multiple Targets
			H
			HCP, Patients, IFU
			None
			None05/24/2023
			Abbott Diagnostics Scarborough, Inc.
			ID NOW COVID-19 2.0
			05/06/2022
			RT, Isothermal amplification, Single Target
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (May 24, 2023)
			None11/07/2022
			Cepheid
			Xpert Xpress CoV-2 plus
			05/10/2022
			Real-time RT-PCR, Screening, Multiple Targets
			H, M, W
			HCP, Patients, IFU for Labs, IFU for Point-of-Care
			None
			None07/28/2022
			Laboratory Corporation of America (Labcorp)
			Labcorp Seasonal Respiratory Virus RT-PCR Test
			05/17/2022
			Real-time RT-PCR, Multi-analyte, Home Collection, Single Target
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Letter Granting EUA Revision(s) (July 28, 2022)
			None07/21/2022
			Nexus Medical Labs, LLC
			Nexus High Throughput SARS-CoV-2 Assay
			05/17/2022
			Real-time RT-PCR, Home Collection, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			Letter Granting EUA Revision(s) (July 21, 2022)
			None08/09/2023
			DxLab Inc.
			DxLab COVID-19 Test
			06/01/2022
			RT-LAMP, Serial Screening, Multiple Targets
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (November 23, 2022)
				Letter Granting EUA Revision(s) (April 28, 2023)
				Letter Granting EUA Revision(s) (August 9, 2023)
			None06/14/2022
			Roche Molecular Systems, Inc.
			cobas SARS-CoV-2 Duo for use on the cobas 6800/8800 Systems
			06/14/2022
			Real-time RT-PCR, Quantitative, Multiple Targets
			H, M
			HCP, Patients, IFU
			None
			None11/18/2022
			Premier Medical Laboratory Services
			Diversified Medical Healthcare SARS-CoV-2 Assay
			11/18/2022
			Real-time RT-PCR, Home Collection, Screening, Multiple Targets
			H
			HCP, Patients, EUA Summary, IFU (Home Collect)
			None
			None09/06/2023
			Pfizer Inc.
			Lucira by Pfizer COVID-19 & Flu Test 11/22/2022
			RT-LAMP, Multiple Targets, Multi-analyte
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (March 22, 2023)
				Letter Granting EUA Revision(s) (August 3, 2023)
				Letter Granting EUA Revision(s) (September 6, 2023)
			None12/19/2022
			OnsiteGene, Inc.
			Hi-Sense COVID-19 Molecular Testing Kit 1.0
			12/19/2022
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, IFU
			None
			None08/16/2023
			Visby Medical, Inc.
			Visby Medical Respiratory Health Test
			12/23/2022
			RT-PCR, Multi-analyte, Multiple Targets
			H, M, W
			HCP, Patients, IFU
			None
			None07/28/2023
			Becton, Dickinson and Company (BD)
			BD Respiratory Viral Panel for BD MAX System 
			02/03/2023
			Real-time RT-PCR, Multi-analyte, Multiple Targets
			M, H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (July 28, 2023)
			None06/30/2023
			LumiraDx UK Ltd.
			LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete Assay 
			02/03/2023
			RT, Non-isothermal Nucleic Acid Amplification qSTAR, Multi-analyte, Single Target
			H
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (June 30, 2023)
			None04/18/2023
			ADL Diagnostics, Inc., dba Anavasi Diagnostics
			The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector
			02/08/2023
			RT-LAMP, Multiple Targets
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (April 18, 2023)
			None02/08/2023
			The HFI Laboratory at Boston University (dba the BU Clinical Testing Laboratory)
			BU SARS-CoV-2 Test
			02/08/2023
			real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			None
			None12/14/2023
			Pfizer Inc.
			Lucira by Pfizer COVID-19 & Flu Home Test
			02/24/2023
			RT, LAMP, Over the Counter (OTC) Home Testing, Multi-analyte, Multiple Targets
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (March 22, 2023)
				Letter Granting EUA Revision(s) (August 3, 2023)
				Letter Granting EUA Revision(s) (September 6, 2023)
			None03/10/2023
			Quest Diagnostics Nichols Institute
			Quest COVID-19 Nucleic Acid Test Collection Kit
			03/10/2023
			Home Collection Kit, Screening
			N/A
			EUA Summary, IFU
			None
			None04/19/2023
			MedArbor, LLC dba MedArbor Diagnostics
			MedArbor Diagnostics SARS-CoV-2 Assay
			04/19/2023
			real-time RT-PCR, Single Target
			H
			HCP, Patients, EUA Summary
			None
			None05/03/2023
			Access Medical Laboratories, Inc.
			Global Direct RT-PCR Test
			05/03/2023
			real-time RT-PCR, Single Target
			H
			HCP, Patients, EUA Summary
			None
			None06/30/2023
			Discover Labs
			Discover Labs COVID-19 Assay
			06/30/2023
			Real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			None
			None07/20/2023
			Alphadera Labs, LLC
			ALPHADx SARS-COV-2 RT-PCR Test
			07/20/2023
			Real-time RT-PCR, Multiple Target(s)
			H
			HCP, Patients, EUA Summary
			None
			None10/13/2023
			MAWD Laboratories
			MAWD Laboratories SARS-CoV-2 Dual Target by RT-PCR
			10/13/2023
			real-time RT-PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			None
			None11/16/2023
			Roche Molecular Systems
			cobas SARS-CoV-2 & Influenza A/B v2
			11/16/2023
			Real-time RT-PCR, Multiple Targets, Multi-analyte
			H, M
			HCP, Patients, IFU
			None
			None12/08/2023
			RCA Laboratory Services LLC dba GENETWORx
			Gx HTIQ SARS-CoV-2 Test
			12/08/2023
			Real-time RT-PCR, Single Target, Screening
			H
			HCP, Patients, EUA Summary
			None
			None12/08/2023
			RCA Laboratory Services LLC dba GENETWORx
			Gx HTKB SARS-CoV-2 Test 12/08/2023
			Real-time RT-PCR, Single Target, Screening
			H
			HCP, Patients, EUA Summary
			None
			None

1 Authorized settings include the following:

H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
	M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
	W - Patient care settings operating under a CLIA Certificate of Waiver.2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.

3 Abbreviations:

RT-PCR = reverse transcriptase polymerase chain reaction;
	RT = reverse transcriptase;
	LAMP = loop-mediated isothermal amplification;
	MALDI-TOF = Matrix Assisted Laser Desorption/Ionization - Time of Flight;
	TMA = Transcription Mediated Amplification;
	qSTAR = Selective Temperature Amplification Reaction;
	CRISPR = clustered regularly interspaced short palindromic repeats;Revision Concerning Viral Mutations

On September 23, 2021, the FDA revised the EUAs of certain molecular, antigen, and serology tests to establish additional Conditions of Authorization in response to the continued emergence of new variants of SARS-CoV-2. The revision requires test developers to update their authorized labeling and evaluate the impact of SARS-CoV-2 viral mutations on their test's performance as outlined in the letter. This revision is effective as of September 23, 2021 for all EUAs that are within the scope of the revision. This revision does not apply to EUAs for authorized IL-6 assays or standalone specimen collection devices and does not apply to EUAs that include substantially equivalent viral mutation conditions of authorization.

The FDA has determined that establishing additional conditions is necessary to mitigate the potential risk of false negative results due to either decreased sensitivity or non-reactivity associated with SARS-CoV-2 viral mutations. As set forth in the September 23, 2021 letter, developers of authorized tests that are within the scope of the revision are now required to routinely monitor emerging viral mutations and their potential impact on the performance of the authorized SARS-CoV-2 test(s).  If potential impacts are identified, the EUA holder must communicate with the FDA and end users about the potential risk that presence of the mutations may have on test performance. The EUA holder must also update their authorized labeling consistent with the revision letter and submit the labeling to the FDA within 3 months of September 23, 2021. By taking these steps, the FDA and the test developer can quickly act in response to the potential risks identified and, when applicable, share the findings on SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.

Viral Mutation Revision Letter - September 23, 2021Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2

On April 20, 2021, the FDA issued an amendment allowing certain authorized molecular diagnostic SARS-CoV-2 tests to be distributed and used to pool anterior nasal respiratory specimens from asymptomatic individuals as part of a serial testing program after developers submit a complete notification, including meeting required validation data, as set forth in the letter. Use of tests for these indications is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, except that tests authorized for use in specific named or designated high complexity laboratories can only be used in such laboratories.

This means that tests with EUAs that are amended by this authorization may be used with pooled anterior nasal specimens from individuals without known or suspected COVID-19 when such individuals are tested as part of a testing program that includes testing at regular intervals, at least once per week. The indications in each appendix (A-H) differ in the number of specimens that can be pooled (up to 3, up to 5, or up to 10) and the type of pooling that can be done (media pooling or swab pooling).

Prior to a test being distributed or used for any new indication, the developer must submit a notification to the FDA with the information required by the amendment, including self-certifying that the applicable validation has been completed. Tests will be added to Exhibit 1 once FDA confirms that the required documentation has been submitted. Please note that being added to Exhibit 1 does not necessarily mean that the FDA has reviewed the underlying validation data submitted or confirmed that the test is appropriately validated.

Amendment Letter
	Appendix J - Sample Updated Fact Sheet for Health Care Providers
	Appendix K - Sample Updated Fact Sheet for Patients*Exhibit 1 of the Pooling and Serial Testing Amendment*

The table below includes information for the authorized RT-PCR molecular diagnostic tests for SARS-CoV-2 amended by this Pooling and Serial Testing Amendment. For authorization documents for each test, see Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2 above.

Date Added to Exhibit 1
			EUA Holder
			Test Name
			Indication(s)*06/24/2021
			Clinical Enterprise, Inc.
			Clinical Enterprise SARS-SoV-2-RT-PCR Assay
			Swab: Up to 10 (Appendix C)06/22/2021
			Biomeme, Inc.
			Biomeme SARS-CoV-2 Real-Time RT-PCR Test
			Swab: Up to 10 (Appendix C)
			Media: Up to 10 (Appendix H)06/23/2021
			Viracor Eurofins Clinical Diagnostics
			Viracor SARS-CoV-2 assay
			Swab: Up to 10 (Appendix C)01/28/2022
			Vela Operations Singapore Pte. Ltd
			ViroKey SARS-CoV-2 RT-PCR Test v2.0
			Media: Up to 3 (Appendix D)

* The indications in each appendix (A-H) differ in the number of specimens that can be pooled (up to 3, up to 5, or up to 10) and the type of pooling that can be done (media or swab pooling).

Tests authorized for Swab Pooling are authorized for:

Qualitative detection of RNA from SARS-CoV-2 in pooled samples containing up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swabs placed in a single vial containing transport media after being collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from any individual, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week as part of a serial testing program.
	This indication is authorized for use in laboratories certified under CLIA to perform high complexity tests except tests authorized for use in specific named or designated laboratories can only be used in such laboratories.Tests authorized for Media Pooling are authorized for:

Qualitative detection of RNA from SARS-CoV-2 in pooled samples containing aliquots of transport media from up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swab specimens that were collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from any individual and placed in individual vials containing transport media, including individuals without symptoms or other reasons to suspect COVID-19, when tested as part of a serial testing program including testing at least once per week.
	This indication is authorized for use in laboratories certified under CLIA to perform high complexity tests except tests authorized for use in specific named or designated laboratories can only be used in such laboratories.Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing

On November 15, 2021, the FDA issued an umbrella EUA for certain RT-PCR molecular-based tests, developed by laboratories, for detection of nucleic acid from SARS-CoV-2 from anterior nasal respiratory specimens for use as part of a serial testing program, that meet certain criteria for eligibility specified in the EUA. Under this EUA, authorized tests can be used with individual or pooled anterior nasal specimens for testing individuals, including individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least once per week. This means that tests authorized by this EUA may be used with individual or pooled anterior nasal respiratory specimens from individuals with or without known or suspected exposure to COVID-19 when such individuals are tested at least once per week, such as testing at regular intervals as part of a testing program implemented by schools, workplaces, or community groups. The indications in each appendix (A-K) differ in the number of specimens that can be pooled (1, up to 3, up to 5, or up to 10), the type of pooling that can be done (media pooling or swab pooling), and whether the test can be used with home collected specimens.

Use of tests authorized by this EUA is limited to use in the single laboratory that developed the authorized test and that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets requirements to perform high complexity tests.

Tests will be added to Exhibit 1 of this EUA following submission of a complete notification to the FDA with the information required by the EUA, including self-certifying that the applicable validation has been completed, and confirmation by the FDA that the required documentation has been submitted. Being added to Exhibit 1 does not necessarily mean that the FDA has reviewed the underlying validation data submitted or confirmed that the test is appropriately validated.

EUA Letter of Authorization - Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing
	Appendix L - Fact Sheet for Health Care Providers (Template)
	Appendix M - Fact Sheet for Patients (Template)
	Appendix N - Test Summary (Template)*Exhibit 1 of the Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing*

This exhibit includes information for the RT-PCR molecular diagnostic tests for SARS-CoV-2 authorized by this umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing. All tests authorized by this umbrella EUA are required to have at least two viral targets on the SARS-CoV-2 genome. Tests with multiple targets are more likely to continue to perform well when new variants emerge.

Date Added
			to Exhibit 1
			EUA Holder
			Test Name
			Additional Indication(s)*
			Authorization Documents**08/01/2022
			Helix Diagnostics
			Helix Diagnostics SARS nCoV-2019 Multiplexed Assay
			None
			Test Summary, HCP, Patients01/05/2023
			Scope Molecular Laboratory
			Scope Molecular Laboratory SARS nCoV-2019 Multiplexed Assay
			None
			Test Summary, HCP, Patients10/06/2023
			Rize Laboratory
			Rize Laboratory SARS nCoV-2019 Multiplexed Assay
			Appendix E
			Test Summary, HCP, Patients

* All tests authorized under this Umbrella EUA are authorized for (as described in appendix A):

Qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swab samples collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from individuals, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week.
	 
	Each test is authorized for use in the single laboratory that developed the authorized test and that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets requirements to perform high complexity tests.Additional indications included in appendices (B-K) differ in the number of specimens that can be pooled (up to 3, up to 5, or up to 10), the type of pooling that can be done (media or swab pooling), and the inclusion of use with home collected specimens.

Tests authorized for Swab Pooling (appendices B-D) are authorized for:

Qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swabs or pooled samples containing up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swabs placed in a single vial after being collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from individuals, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week.
	 
	This test is authorized for use in the single laboratory that developed the test and that is certified under CLIA and meets requirements to perform high complexity tests.Tests authorized for Media Pooling (appendices E-I) are authorized for:

Qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swabs or pooled samples containing aliquots of media from up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swab specimens that were collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from individuals, including individuals without symptoms or other reasons to suspect COVID-19 and placed in individual vials when tested at least once per week.
	 
	This test is authorized for use in the single laboratory that developed the test and that is certified under CLIA and meets requirements to perform high complexity tests.Tests authorized for Home Specimen Collection (appendices J-K) are authorized for the applicable above indications with the following addition regarding specimen collection:

{or self-collected at home using the following authorized home collection kit(s): [specific named home collection kit(s) with which the test was validated] when used consistent with the home collection kit's authorization for individuals tested at least once per week}** Authorization Documents include the Test Summary, Fact Sheet for Healthcare Providers (HCP) and Fact Sheet for Patients.

EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests

On March 31, 2020, the FDA issued an umbrella EUA for molecular laboratory developed tests (LDTs) for detection of SARS-CoV-2 that meet certain criteria for eligibility described in the EUA. Under this EUA, authorized tests are authorized for use in the single laboratory that developed the authorized test and that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.  Tests authorized under this umbrella EUA were added to Appendix A in the table below.

On November 15, 2021, the FDA reissued this EUA such that only tests that are listed in Appendix A are authorized for use as described in the EUA, and no additional tests will be authorized by this EUA.  The reissued EUA also includes updated Conditions of Authorization and Fact Sheets to reflect the most up-to-date information.

EUA Letter of Authorization - Laboratories Who Have Developed a Molecular-Based Test (LDTs) for Coronavirus Disease 2019 (COVID-19)
	Fact Sheet for Healthcare Providers
	Fact Sheet for Patients
	See Appendix A table below for a list of tests authorized under this EUAAppendix A: Authorized Molecular-Based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2

The table below includes information for the high complexity molecular-based laboratory developed SARS-CoV-2 assays authorized by this EUA during the COVID-19 public health emergency.

To see additional authorization documents, such as letters granting EUA amendments or revisions, for a specific test, select the plus (+) button beside the "Date Last Updated" for each test.

All tests in this table are multiple target tests unless noted with an asterisk (*). Multiple target tests are designed to detect two or more viral targets, or sections of the SARS-CoV-2 genome. Tests with an asterisk are single target tests. Single target tests are designed to detect only one viral target on the SARS-CoV-2 genome. Tests with multiple targets are more likely to continue to perform well when new variants emerge. Tests with single targets are more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants.

All authorized devices in the table below are assigned the QJR product code.

Date Last Updated
			Laboratory
			Letter Granting Inclusion under EUA and Original Issue Date
			EUA Summary
			Other Documents06/04/2020
			Altru Diagnostics, Inc.
			Altru Dx SARS-CoV-2 RT-PCR assay
			04/30/2020
			EUA Summary
			Letter Granting EUA Amendment(s) (June 4, 2020)

			Viral Mutation Revision Letter - September 23, 202108/24/2022
			Nationwide Children's Hospital
			SARS-CoV-2 Assay
			04/27/2020
			EUA Summary
			Viral Mutation Revision Letter - September 23, 202109/22/2020
			Diatherix Eurofins Laboratory
			SARS-CoV-2 PCR Test
			04/22/2020
			EUA Summary
			Viral Mutation Revision Letter - September 23, 202104/10/2020
			Orig3n, Inc.
			Orig3n 2019 Novel Coronavirus (COVID-19) Test
			04/10/2020
			EUA Summary
			Viral Mutation Revision Letter - September 23, 202104/10/2020
			Specialty Diagnostic (SDI) Laboratories
			SDI SARS-CoV-2 Assay *
			04/10/2020
			EUA Summary
			Viral Mutation Revision Letter - September 23, 202104/02/2020
			Infectious Disease Diagnostics Laboratory - Children's Hospital of Philadelphia
			SARS-CoV-2 RT-PCR test *
			04/02/2020
			EUA Summary
			Viral Mutation Revision Letter - September 23, 202103/07/2023
			Yale New Haven Hospital,
			Clinical Virology Laboratory
			SARS-CoV-2 PCR test
			03/31/2020
			EUA Summary
			Letter Granting EUA Amendment(s) (June 4, 2020)

			Viral Mutation Revision Letter - September 23, 2021

			Letter Granting EUA Revision(s) (March 07, 2023)03/28/2023
			Integrity Laboratories
			SARS-CoV-2 Assay
			04/13/2020
			EUA Summary
			Viral Mutation Revision Letter - September 23, 202109/21/2020
			Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory
			CDI Enhanced COVID-19 Test
			04/15/2020
			EUA Summary
			Viral Mutation Revision Letter - September 23, 202109/21/2020
			CirrusDx Laboratories
			CirrusDx SARS-CoV-2 Assay
			04/15/2020
			EUA Summary
			Viral Mutation Revision Letter - September 23, 202103/07/2023
			Southwest Regional PCR Laboratory LLC. dba MicroGen DX
			COVID-19 Key
			04/23/2020
			EUA Summary
			Viral Mutation Revision Letter - September 23, 202104/24/2020
			Ultimate Dx Laboratory
			UDX SARS-CoV-2 Molecular Assay *
			04/24/2020
			EUA Summary
			Viral Mutation Revision Letter - September 23, 202101/28/2021
			AIT Laboratories
			SARS-CoV-2 Assay
			04/24/2020
			EUA Summary
			Viral Mutation Revision Letter - September 23, 202103/22/2023
			UTMG Pathology Laboratory
			UTHSC/UCH SARS-CoV-2-RT-PCR Assay
			05/03/2020
			EUA Summary
			Letter Granting EUA Amendment(s) (July 22, 2020)

			Viral Mutation Revision Letter - September 23, 2021

			Letter Granting EUA Revision(s) - March 22, 202312/28/2020
			Biocollections Worldwide, Inc.
			Biocollections Worldwide SARS-Co-V-2 Assay
			05/07/2020
			EUA Summary
			Viral Mutation Revision Letter - September 23, 202109/14/2020
			Columbia University Laboratory of Personalized Genomic Medicine
			TRIPLEX CII-SARS-CoV-2 rRT-PCR TEST
			05/12/2020
			EUA Summary
			Letter Granting EUA Revision(s) (September 14, 2020)

			Viral Mutation Revision Letter - September 23, 202105/13/2020
			One Health Laboratories, LLC
			SARS-CoV-2 Real-Time RT-PCR-Test
			05/13/2020
			EUA Summary
			Viral Mutation Revision Letter - September 23, 202101/29/2021
			CSI Laboratories
			CSI SARS-CoV-2 RT PCR Test
			06/01/2020
			EUA Summary
			Viral Mutation Revision Letter - September 23, 202105/22/2020
			Avera Institute for Human Genetics
			Avera Institute for Human Genetics SARS-CoV-2 Assay
			05/22/2020
			EUA Summary
			Viral Mutation Revision Letter - September 23, 202106/10/2020
			Warrior Diagnostics, Inc.
			Warrior Diagnostics SARS-CoV-2 Assay
			06/10/2020
			EUA Summary
			Viral Mutation Revision Letter - September 23, 202105/03/2022
			Cormeum Laboratory Services
			Cormeum SARS-CoV-2 Assay
			06/12/2020
			EUA Summary
			Viral Mutation Revision Letter - September 23, 2021

			Letter Granting EUA Revision(s) (May 3, 2022)

1 The tests listed in this table are all molecular-based tests for COVID-19 and the authorized setting is for use in the identified laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

                                                                                  Content current as of:
      01/29/2024
              
              
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