In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2

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:

In Vitro Diagnostic EUAs: Overview and Templates

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 Tests

Individual 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)
05/14/2024	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	Letter Granting EUA Revision(s) (May 14, 2024)	None
06/08/2023	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	None
06/05/2023	Acutis Diagnostics	SARS-CoV-2 Acutis Multiplex Assay 06/05/2023	real-time RT-PCR, Multiple Targets	H	HCP, Patient, EUA Summary	None	None
04/26/2023	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	None
03/26/2024	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	None
04/12/2024	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) Letter Granting EUA Revision(s) (April 12, 2024)	None
09/13/2022	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	None
07/28/2022	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)	None
04/26/2022	Audere	HealthPulse@home Fusion 04/26/2022	Home Collection Kit, Screening, Single Target	N/A	EUA Summary, IFU	None	None
12/17/2021	UCSD BCG EXCITE Lab	UCSD EXCITE COVID-19 Test 12/17/2021	Real-time RT-PCR, Home Collection, Screening, Multiple Targets	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
08/24/2022	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)	None
07/21/2022	Meridian Bioscience, Inc.	Revogene SARS-CoV-2 11/09/2021	Real time RT-PCR, Single Target	H, M	HCP, Patients, IFU	None	None
01/26/2024	Revvity, Inc.	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)	None
10/19/2022	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	None
12/14/2021	Quest Diagnostics Nichols Institute	Quest Diagnostics Collection Kit for COVID-19 10/08/2021	Home Collection Kit	N/A	EUA Summary, IFU	None	None
07/28/2022	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)	None
07/18/2023	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)	None
07/01/2024	SalivaDirect, Inc.	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)	None
07/01/2024	SalivaDirect, Inc.	SalivaDirect DTC Saliva Collection Kit 08/27/2021	Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening	N/A	Individual, EUA Summary, IFU	None	None
08/25/2021	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	None
08/25/2021	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	None
08/23/2021	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	None
01/11/2022	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	None
03/30/2023	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)	None
11/15/2022	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	None
03/07/2023	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	None
05/20/2021	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	None
04/26/2022	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	None
04/26/2022	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	None
01/05/2021	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	None
08/18/2020	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	None
07/22/2021	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)	None
06/28/2022	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	None
03/10/2023	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	None
04/17/2023	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)	None
06/21/2022	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)	None
03/23/2022	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)	None
08/31/2022	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)	None
02/08/2023	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)	None
05/31/2022	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)	None
01/31/2024	Revvity, Inc.	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)	None
10/04/2022	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	None
10/19/2022	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	None
08/27/2021	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)	None
07/29/2021	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	None
01/22/2021	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	None
03/15/2023	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	None
03/14/2023	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)	None
03/27/2023	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	None
04/28/2020	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	None
05/21/2021	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	None
01/11/2022	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	None
07/14/2022	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)	None
12/28/2020	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	None
03/09/2023	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	None
04/16/2020	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	None
02/15/2023	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	None
02/24/2023	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	None
08/08/2020	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	None
12/13/2022	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	None
03/01/2023	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	None
09/13/2022	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	None
03/25/2022	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)	None
11/01/2022	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	None
02/18/2022	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	None
08/18/2021	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 Kit
02/14/2022	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)	None
05/08/2020	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	None
12/09/2022	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)	None
06/28/2022	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)	None
08/30/2023	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)	None
10/12/2022	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	None
06/22/2021	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	None
03/02/2023	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)	None
02/23/2022	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	None
05/25/2021	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	None
04/01/2021	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 Setting
01/05/2022	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	None
12/28/2020	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	None
08/18/2021	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	None
02/01/2022	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)	None
05/17/2021	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 Test
03/03/2023	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	None
04/13/2022	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	None
01/19/2022	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	None
05/12/2023	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	None
08/27/2021	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	None
06/08/2021	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	None
01/13/2022	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	None
05/10/2021	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	None
06/17/2020	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	None
06/24/2021	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	None
09/21/2020	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	None
06/23/2020	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	None
08/26/2021	Gencurix, Inc.	GenePro SARS-CoV-2 Test 06/23/2020	Real-time RT-PCR, Multiple Targets	H	HCP, Patients, IFU	None	None
01/29/2021	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	None
01/06/2022	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	None
04/26/2022	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)	None
06/26/2020	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	None
09/24/2020	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	None
01/26/2022	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)	None
05/28/2021	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	None
05/19/2021	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	None
08/20/2024	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)	None
02/13/2023	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	None
02/05/2021	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-PCRv
12/28/2020	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	None
07/09/2020	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	None
12/28/2020	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	None
01/04/2022	KogeneBiotech Co., Ltd.	PowerChek 2019-nCoV Real-time PCR Kit 07/13/2020	Real-time RT-PCR, Multiple Targets	H	HCP, Patients, IFU	None	None
11/01/2022	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	None
07/13/2020	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	None
03/10/2023	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	None
03/10/2023	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	None
12/14/2021	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	None
09/21/2020	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	None
07/28/2021	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	None
01/20/2022	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	None
10/22/2020	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	None
07/24/2020	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	None
07/09/2021	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	None
09/21/2020	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	None
01/29/2021	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	None
07/30/2020	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	None
02/27/2023	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	None
07/31/2020	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	None
06/17/2021	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	None
09/21/2020	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	None
08/03/2020	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	None
07/14/2021	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	None
08/06/2020	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	None
06/24/2021	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	None
01/06/2022	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	None
12/28/2020	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	None
01/28/2021	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	None
03/24/2023	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	None
05/28/2021	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	None
07/01/2024	SalivaDirect, Inc.	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)	None
08/17/2020	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	None
12/09/2020	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	None
06/14/2023	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)	None
02/08/2021	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	None
10/02/2020	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	None
09/21/2020	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	None
02/17/2023	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	None
12/28/2020	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	None
05/27/2022	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	None
01/28/2021	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	None
06/17/2021	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	None
12/28/2020	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	None
07/21/2022	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)	None
03/31/2023	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 PCR
02/10/2023	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)	None
10/31/2020	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	None
08/27/2021	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	None
07/15/2021	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	None
05/06/2021	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	None
06/12/2023	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)	None
03/24/2022	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	None
02/16/2023	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	None
11/19/2021	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	None
01/28/2022	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)	None
04/02/2021	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	None
03/18/2022	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	None
12/28/2020	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	None
06/05/2023	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)	None
01/11/2022	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	None
10/08/2020	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	None
04/04/2024	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	Viral Mutation Revision Letter - September 23, 2021	None
08/04/2021	Spectrum Solutions LLC	SDNA-1000 Saliva Collection Device 10/08/2020	Saliva Collection Device	N/A	EUA Summary, IFU	None	None
07/10/2023	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)	None
06/10/2021	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	None
01/12/2022	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	None
08/13/2021	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)	None
05/04/2021	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	None
10/31/2024	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	None
10/28/2020	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	None
06/14/2023	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)	None
01/22/2021	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	None
03/03/2022	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	None
10/15/2021	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	None
11/24/2020	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	None
12/14/2021	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	None
11/01/2022	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)	None
08/12/2022	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)	None
12/11/2020	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	None
02/14/2023	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)	None
05/05/2022	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)	None
10/11/2022	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	None
06/08/2022	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	None
07/16/2021	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	None
01/19/2021	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	None
09/06/2022	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	None
06/24/2021	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	None
03/20/2023	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)	None
08/07/2022	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	None
02/23/2022	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 Kit
03/02/2023	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	None
01/14/2022	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	None
01/19/2022	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	None
06/28/2022	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)	None
10/03/2024	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) Letter Granting EUA Revision(s) (October 3, 2024)	None
08/07/2022	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	None
01/26/2022	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)	None
09/03/2021	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	None
01/26/2022	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)	None
08/31/2022	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	None
06/29/2023	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)	None
11/04/2022	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)	None
06/24/2021	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	None
04/13/2021	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	None
07/01/2024	SalivaDirect, Inc.	SalivaDirect At-Home Collection Kit 04/09/2021	Home Collection Kit, Saliva, Screening	N/A	EUA Summary	Letter Granting EUA Revision(s) (May 6, 2021)	None
06/15/2022	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)	None
06/02/2021	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	None
06/02/2021	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	None
07/22/2021	PathogenDx, Inc.	DetectX-Rv 04/20/2021	RT-PCR, DNA Microarray Hybridization, Multiple Targets	H	HCP, Patients, IFU	None	None
05/17/2021	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	None
05/17/2021	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	None
07/08/2021	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	None
06/17/2021	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	None
06/17/2021	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	None
11/01/2022	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)	None
07/01/2021	Everlywell, Inc.	Everlywell COVID-19 & Flu Test Home Collection Kit 07/01/2021	Home Collection Kit, Multi-analyte	N/A	IFU, EUA Summary	None	None
03/31/2023	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)	None
03/20/2023	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)	None
11/29/2021	Kwokman Diagnostics, LLC	Kwokman Diagnostics COVID-19 Home Collection Kit 08/13/2021	Home Collection Kit	N/A	IFU, EUA Summary	None	None
09/22/2021	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	None
10/14/2021	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	None
07/19/2022	Audere	HealthPulse@home 11/30/2021	Home Collection Kit, Screening, Single Target	N/A	EUA Summary, IFU	None	None
04/21/2022	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	None
01/25/2024	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)	None
07/28/2022	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)	None
07/14/2022	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	None
07/07/2022	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)	None
03/21/2022	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	None
03/21/2022	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	None
10/06/2022	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)	None
04/06/2022	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	None
05/25/2022	UCSD BCG EXCITE Lab	UCSD EXCITE COVID-19 EL Test 04/07/2022	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)	None
08/17/2022	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)	None
08/24/2022	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)	None
04/21/2022	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	None
05/24/2023	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)	None
11/07/2022	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	None
07/28/2022	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)	None
07/21/2022	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)	None
08/09/2023	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)	None
06/14/2022	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	None
11/18/2022	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	None
09/17/2024	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)	None
12/19/2022	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	None
08/16/2023	Visby Medical, Inc.	Visby Medical Respiratory Health Test 12/23/2022	RT-PCR, Multi-analyte, Multiple Targets	H, M, W	HCP, Patients, IFU	None	None
04/16/2024	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) Letter Granting EUA Revision(s) (March 6, 2023) Letter Granting EUA Revision(s) (April 16, 2024)	None
02/08/2023	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	None
12/14/2023	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)	None
03/10/2023	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	None
04/19/2023	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	None
05/03/2023	Access Medical Laboratories, Inc.	Global Direct RT-PCR Test 05/03/2023	real-time RT-PCR, Single Target	H	HCP, Patients, EUA Summary	None	None
06/30/2023	Discover Labs	Discover Labs COVID-19 Assay 06/30/2023	Real-time RT-PCR, Multiple Targets	H	HCP, Patients, EUA Summary	None	None
07/20/2023	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	None
10/13/2023	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	None
11/16/2023	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	None
12/08/2023	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	None
12/08/2023	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
03/19/2024	Tetracore, Inc.	EZ-SARS-CoV-2 Real-Time RT-PCR 03/19/2024	Real-time RT-PCR, Multiple Targets	H	HCP, Patients, IFU	None	None
04/01/2024	LMSI, LLC d/b/a Lighthouse Lab Services	SalivaNow SARS-CoV-2 Assay 04/01/2024	Real-time RT-PCR, Saliva, Single Target	H	HCP, Patients, IFU	None	None
08/09/2024	Roche Molecular Systems, Inc.	cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test 06/07/2024	RT-PCR, Multiple Targets, Multi-analyte	H, M, W	HCP, Patients, IFU	Letter Granting EUA Revision(s) (August 09, 2024)	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, 2021

Pooling 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.

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.

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, Patients
01/05/2023	Scope Molecular Laboratory	Scope Molecular Laboratory SARS nCoV-2019 Multiplexed Assay	None	Test Summary, HCP, Patients
10/06/2023	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 EUA

Appendix 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 Documents
06/04/2020	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, 2021
08/24/2022	Nationwide Children's Hospital	SARS-CoV-2 Assay 04/27/2020	EUA Summary	Viral Mutation Revision Letter - September 23, 2021
09/22/2020	Diatherix Eurofins Laboratory	SARS-CoV-2 PCR Test 04/22/2020	EUA Summary	Viral Mutation Revision Letter - September 23, 2021
04/10/2020	Orig3n, Inc.	Orig3n 2019 Novel Coronavirus (COVID-19) Test 04/10/2020	EUA Summary	Viral Mutation Revision Letter - September 23, 2021
04/10/2020	Specialty Diagnostic (SDI) Laboratories	SDI SARS-CoV-2 Assay * 04/10/2020	EUA Summary	Viral Mutation Revision Letter - September 23, 2021
04/02/2020	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, 2021
03/07/2023	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, 2021
09/21/2020	Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory	CDI Enhanced COVID-19 Test 04/15/2020	EUA Summary	Viral Mutation Revision Letter - September 23, 2021
09/21/2020	CirrusDx Laboratories	CirrusDx SARS-CoV-2 Assay 04/15/2020	EUA Summary	Viral Mutation Revision Letter - September 23, 2021
03/07/2023	Southwest Regional PCR Laboratory LLC. dba MicroGen DX	COVID-19 Key 04/23/2020	EUA Summary	Viral Mutation Revision Letter - September 23, 2021
04/24/2020	Ultimate Dx Laboratory	UDX SARS-CoV-2 Molecular Assay * 04/24/2020	EUA Summary	Viral Mutation Revision Letter - September 23, 2021
01/28/2021	AIT Laboratories	SARS-CoV-2 Assay 04/24/2020	EUA Summary	Viral Mutation Revision Letter - September 23, 2021
03/22/2023	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, 2023
12/28/2020	Biocollections Worldwide, Inc.	Biocollections Worldwide SARS-Co-V-2 Assay 05/07/2020	EUA Summary	Viral Mutation Revision Letter - September 23, 2021
09/14/2020	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, 2021
05/13/2020	One Health Laboratories, LLC	SARS-CoV-2 Real-Time RT-PCR-Test 05/13/2020	EUA Summary	Viral Mutation Revision Letter - September 23, 2021
01/29/2021	CSI Laboratories	CSI SARS-CoV-2 RT PCR Test 06/01/2020	EUA Summary	Viral Mutation Revision Letter - September 23, 2021
05/22/2020	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, 2021
06/10/2020	Warrior Diagnostics, Inc.	Warrior Diagnostics SARS-CoV-2 Assay 06/10/2020	EUA Summary	Viral Mutation Revision Letter - September 23, 2021
05/03/2022	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.

U.S. Food and Drug Administration