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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 - Antigen Diagnostic Tests for SARS-CoV-2COVID-19 Emergency Use Authorizations for Medical Devices In Vitro Diagnostics EUAs - Antigen 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
	Molecular 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 Antigen Diagnostic Tests for SARS-CoV-2
	Revision Concerning Viral Mutations
	Antigen EUA Revisions for Serial (Repeat) TestingIndividual EUAs for Antigen Diagnostic Tests for SARS-CoV-2

The table below includes information about authorized SARS-CoV-2 antigen diagnostic tests that have been authorized individually. 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).

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 antigen 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 antigen target, currently either a section of the spike protein or a section of the nucleocapsid protein;
	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 more than one section of the proteins that make up SARS-CoV-2;
	more likely to continue to perform as labeled as new variants emerge.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 each EUA.

Authorized EUA devices in the table below for SARS-CoV-2 antigen diagnostic tests are assigned the QKP product code. Antigen multi-analyte respiratory panel tests authorized in the table below are assigned the QMN product code.

Date EUA Issued or Last Updated
			Entity
			Diagnostic (Most Recent Letter of Authorization) and Date EUA Originally Issued
			Attributes
			Authorized Setting(s)1
			Authorization Documents2
			Other Documents
			Other Brand Name(s)02/22/2023
			Mologic, Inc.
			COVI-Go SARS-CoV-2 Ag Self-Test
			02/22/2023
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			None
			None06/16/2023
			PHASE Scientific International, Ltd.
			INDICAID COVID-19 Rapid Antigen At-Home Test 03/16/2022
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (May 12, 2022)
				Letter Granting EUA Revision(s) (August 12, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (December 22, 2022)
				Letter Granting EUA Revision(s) (June 16, 2023)
			None12/11/2023
			SD Biosensor, Inc.
			Pilot COVID-19 At-Home Test
			12/24/2021
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target, Telehealth Proctor Supervised (optional)
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (March 7, 2022)
				Letter Granting EUA Revision(s) (April 28, 2022)
				Letter Granting EUA Revision(s) (June 24, 2022)
				Letter Granting EUA Revision(s) (October 14, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (December 11, 2023)
			None08/24/2023
			iHealth Labs, Inc.
			iHealth COVID-19 Antigen Rapid Test
			11/05/2021
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target, Telehealth Proctor Supervised (optional)
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (March 29, 2022)
				Letter Granting EUA Revision(s) (April 4, 2022)
				Letter Granting EUA Revision(s) (July 8, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (January 11, 2023)
			GoToKnow COVID-19 Antigen Rapid Test03/02/2023
			Celltrion USA, Inc.
			Celltrion DiaTrust COVID-19 Ag Home Test
			10/21/2021
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Multiple Targets
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (November 4, 2022)
				Letter Granting EUA Revision(s) (January 20, 2023)
				Letter Granting EUA Revision(s) (March 02, 2023)
			None03/15/2023
			ACON Laboratories, Inc
			Flowflex COVID-19 Antigen Home Test
			10/04/2021
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (October 15, 2021)
				Letter Granting EUA Revision(s) (April 20, 2022)
				Letter Granting EUA Revision(s) (September 2, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (November 18, 2022)
				Letter Granting EUA Revision(s) (March 15, 2023)
			On/Go One COVID-19 Antigen Home Test11/15/2023
			SEKISUI Diagnostics, LLC.
			OSOM COVID-19 Antigen Rapid Test 09/24/2021
			Lateral Flow, Visual Read, Serial Screening, Single Target
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (August 24, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (November 15, 2023)
			None02/27/2023
			Quidel Corporation
			Sofia SARS Antigen FIA
			05/08/2020
			Lateral Flow, Fluorescence, Instrument Read, Serial Screening, Single Target
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (June 9, 2020)
				Letter Granting EUA Amendment(s) (July 17, 2020)
				Viral Mutation Revision Letter - September 23, 2021
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (February 27, 2023)
			None03/21/2023
			Becton, Dickinson and Company (BD)
			BD Veritor System for Rapid Detection of SARS-CoV-2
			07/02/2020
			Chromatographic Digital Immunoassay, Instrument Read, Serial Screening, Single Target
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Amendment(s) (July 23, 2020)
				Letter Granting EUA Revision(s) (December 10, 2021)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (March 21, 2023)
			None08/15/2023
			LumiraDx UK Ltd.
			LumiraDx SARS-CoV-2 Ag Test
			08/18/2020
			Microfluidic Immunofluorescence Assay, Instrument Read, Serial Screening, Single Target
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (January 26, 2021)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (February 17, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (March 29, 2023)
			None01/13/2023
			Abbott Diagnostics Scarborough, Inc.
			BinaxNOW COVID-19 Ag Card
			08/26/2020
			Lateral Flow, Visual Read, Single Target, Serial Screening
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (April 6, 2021)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (January 7, 2022)
				Letter Granting EUA Revision(s) (February 4, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (November 21, 2022)
			None08/08/2023
			Quidel Corporation
			Sofia 2 Flu + SARS Antigen FIA
			10/02/2020
			Lateral Flow, Fluorescence, Instrument Read, Multi-Analyte, Single Target
			H, M, W
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (March 31, 2023)
			None01/17/2023
			Access Bio, Inc.
			CareStart COVID-19 Antigen test
			10/08/2020
			Lateral Flow, Visual Read, Serial Screening, Single Target
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (March 15, 2021)
				Letter Granting EUA Revisions(s) (July 16, 2021)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (December 2, 2021)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (January 17, 2023)
			None03/27/2023
			Celltrion USA, Inc.
			Sampinute COVID-19 Antigen MIA
			10/23/2020
			Magnetic Force-assisted Electrochemical Sandwich Immunoassay (MESIA), Single Target
			H, M
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (March 27, 2023)
			None02/16/2023
			Ellume Limited
			Ellume COVID-19 Home Test
			12/15/2020
			Lateral Flow, Fluorescence, Instrument Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test), FAQ
			Viral Mutation Revision Letter - September 23, 2021
				Repeat Testing Revision Letter - November 1, 2022
			None04/10/2023
			Abbott Diagnostics Scarborough, Inc.
			BinaxNOW COVID-19 Ag Card Home Test
			12/16/2020
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Telehealth Proctor Supervised, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (January 7, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (April 10, 2023)
			None04/04/2023
			Quidel Corporation
			QuickVue SARS Antigen Test
			12/18/2020
			Lateral Flow, Visual Read, Serial Screening, Single Target
			H, M, W
			HCP, Patients, IFU
			Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (April 04, 2023)
			None03/01/2023
			Ortho Clinical Diagnostics, Inc.
			VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack
			01/11/2021
			Chemiluminescence Immunoassay, Instrument Read, Single Target
			H, M
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (November 16, 2021)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (March 1, 2023)
			None05/12/2023
			Princeton BioMeditech Corp.
			Status COVID-19/Flu A&B
			02/04/2021
			Lateral Flow, Visual Read, Multi-analyte, Single Target
			H, M, W
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (March 21, 2023)
				Letter Granting EUA Revision(s) (May 12, 2023)
			None03/30/2023
			Quidel Corporation
			QuickVue At-Home COVID-19 Test
			03/01/2021
			Lateral Flow, Visual Read, Prescription Home Testing, Single Target
			Home, H, M, W
			HCP, Patients, IFU, IFU (Home Test)
			Viral Mutation Revision Letter - September 23, 2021
				Repeat Testing Revision Letter - November 1, 2022
			None05/12/2023
			Becton, Dickinson and Company (BD)
			BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B
			03/24/2021
			Chromatographic Digital Immunoassay, Instrument Read, Multi-analyte, Single Target
			H, M, W
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (May 12, 2023)
			None02/17/2023
			Quidel Corporation
			QuickVue At-Home OTC COVID-19 Test
			03/31/2021
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (July 21, 2022)
				Letter Granting EUA Revision(s) (September 23, 2022)
				Repeat Testing Revision Letter - November 1, 2022
			CVS Health At Home COVID-19 Test Kit
				Walgreens At-Home COVID-19 Test Kit11/21/2023
			Abbott Diagnostics Scarborough, Inc.
			BinaxNOW COVID-19 Antigen Self Test
			03/31/2021
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (January 7, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (December 21, 2022)
			None04/21/2023
			DiaSorin, Inc.
			LIAISON SARS-CoV-2 Ag
			03/26/2021
			CLIA, Single Target
			H, M
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (July 12 2021)
				Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (February 16, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (April 21, 2023)
			None05/03/2023
			Qorvo Biotechnologies, LLC.
			Omnia SARS-CoV-2 Antigen Test
			04/13/2021
			Bulk Acoustic Wave (BAW) Biosensor, Instrument Read, Serial Screening, Single Target
			H, M, W
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (October 25, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (March 1, 2023)
				Letter Granting EUA Revision(s) (May 5, 2023)
			None03/02/2023
			Celltrion USA, Inc.
			Celltrion DiaTrust COVID-19 Ag Rapid Test
			04/16/2021
			Lateral Flow, Visual Read, Serial Screening, Multiple Targets
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (August 11, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (November 4, 2022)
				Letter Granting EUA Revision(s) (January 20, 2023)
				Letter Granting EUA Revision(s) (March 02, 2023)
			Humasis COVID-19 Ag Test12/23/2022
			InBios International, Inc.
			SCoV-2 Ag Detect Rapid Test
			05/06/2021
			Lateral Flow, Visual Read, Serial Screening, Single Target
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (March 3, 2022)
				Letter Granting EUA Revision(s) (May 26, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (December 23, 2022)
			None03/29/2023
			Salofa Oy
			Sienna-Clarity COVID-19 Antigen Rapid Test Cassette
			05/20/2021
			Lateral Flow, Visual Read, Single Target
			H, M, W
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (December 17, 2021)
				Letter Granting EUA Revision(s) (June 09, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (March 29, 2023)
			Sienna COVID-19 Antigen Rapid Test Cassette
				Clarity COVID-19 Antigen Rapid Test Cassette
				OVIOS COVID-19 Antigen Rapid Test Cassette
				Spring Health COVID-19 Antigen Rapid Test
				Salocor COVID-19 Antigen Rapid Test Cassette09/26/2023
			OraSure Technologies, Inc.
			InteliSwab COVID-19 Rapid Test Rx
			06/04/2021
			Lateral Flow, Visual Read, Prescription Home Testing, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (August 3, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (March 23, 2023)
				Letter Granting EUA Revision(s) (September 26, 2023)
			None09/26/2023
			OraSure Technologies, Inc.
			InteliSwab COVID-19 Rapid Test
			06/04/2021
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening , Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (August 3, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (March 23, 2023)
				Letter Granting EUA Revision(s) (September 26, 2023)
			None09/26/2023
			OraSure Technologies, Inc.
			InteliSwab COVID-19 Rapid Test Pro
			06/04/2021
			Lateral Flow, Visual Read, Serial Screening , Single Target
			H, M, W
			HCP, Patients, IFU
			Viral Mutation Revision Letter - September 23, 2021
				Letter Granting EUA Revision(s) (August 3, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (January 17, 2023)
				Letter Granting EUA Revision(s) (March 23, 2023)
				Letter Granting EUA Revision(s) (April 4, 2023)
				Letter Granting EUA Revision(s) (August 22, 2023)
				Letter Granting EUA Revision(s) (September 26, 2023)
			None02/01/2023
			Ellume Limited
			ellume.lab COVID Antigen Test
			07/08/2021
			Lateral Flow, Fluorescence, Instrument Read, Single Target
			H, M, W
			HCP, Patients, IFU
			Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (February 01, 2023)
			None02/21/2023
			GenBody Inc.
			GenBody COVID-19 Ag
			07/13/2021
			Lateral Flow, Visual Read, Serial Screening, Single Target
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (June 13, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (February 21, 2023)
			None06/16/2023
			PHASE Scientific International, Ltd.
			INDICAID COVID-19 Rapid Antigen Test
			07/28/2021
			Lateral Flow, Visual Read, Serial Screening, Single Target
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (January 14, 2022)
				Letter Granting EUA Revision(s) (February 22, 2022)
				Letter Granting EUA Revision(s) (May 12, 2022)
				Letter Granting EUA Revision(s) (August 12, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (December 28, 2022)
				Letter Granting EUA Revision(s) (June 16, 2023)
			None03/14/2023
			Access Bio, Inc.
			*CareStart* COVID-19 Antigen Home Test
			08/02/2021
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (August 23, 2021)
				Letter Granting EUA Revision(s) (January 22, 2022)
				Letter Granting EUA Revision(s) (May 12, 2022)
				Letter Granting EUA Revisions(s) (June 7, 2022)
				Letter Granting EUA Revision(s) (August 29, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (February 01, 2023)
			On/Go COVID-19 Antigen Self-Test05/18/2023
			QIAGEN GmbH
			QIAreach SARS-CoV-2 Antigen
			08/05/2021
			Digital Lateral Flow, Fluorescence, Instrument Read, Single Target
			H, M
			HCP, Patients, IFU
			Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (May 18, 2023)
			None01/06/2023
			InBios International Inc.
			SCoV-2 Ag Detect Rapid Self-Test
			11/22/2021
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (March 3, 2022)
				Letter Granting EUA Revision(s) (May 26, 2022)
				Letter Granting EUA Revision(s) (September 28, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (December 23, 2022)
			None12/15/2022
			Nano-Ditech Corp.
			Nano-Check COVID-19 Antigen Test
			12/06/2021
			Lateral Flow, Visual Read, Serial Screening, Single Target
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (Feburary 1, 2022)
				Repeat Testing Revision Letter - November 1, 2022
			None02/17/2023
			Siemens Healthineers
			CLINITEST Rapid COVID-19 Antigen Self-Test
			12/29/2021
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (June 23, 2022)
				Letter Granting EUA Revision(s) (October 12, 2022)
				Repeat Testing Revision Letter - November 1, 2022
			None04/28/2023
			iHealth Labs, Inc.
			iHealth COVID-19 Antigen Rapid Test Pro
			01/14/2022
			Lateral Flow, Visual Read, Serial Screening, Single Target
			H, M, W
			HCP, Patients, IFU
			Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (December 27, 2022)
			None10/26/2023
			Maxim Biomedical, Inc.
			MaximBio ClearDetect COVID-19 Antigen Home Test
			01/19/2022
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (March 30, 2022)
				Letter Granting EUA Revision(s) (July 22, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (December 16, 2022)
				Letter Granting EUA Revision(s) (January 09, 2023)
				Letter Granting EUA Revision(s) (March 21, 2023)
				Letter Granting EUA Revision(s) (July 05, 2023)
				Letter Granting EUA Revision(s) (October 26, 2023)
			None02/24/2023
			Oceanit Foundry LLC
			ASSURE-100 Rapid COVID-19 Test
			02/28/2022
			Lateral Flow, Visual Read, Single Target
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (May 4, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (December 2, 2022)
				Letter Graning EUA Revision(s) (February 24, 2023)
			None05/03/2023
			Siemens Healthcare Diagnostics, Inc.
			Atellica IM SARS-CoV-2 Antigen (CoV2Ag)
			03/11/2022
			CLIA, Single Target
			H, M
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (October 25, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (May 3, 2023)
			None05/03/2023
			Siemens Healthcare Diagnostics, Inc.
			ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag)
			03/11/2022
			CLIA, Single Target
			H, M
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (October 25, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (May 3, 2023)
			None09/26/2023
			OSANG LLC
			OHC COVID-19 Antigen Self Test 04/06/2022
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (August 19, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (February 21, 2023)
				Letter Granting EUA Revision(s) (March 15, 2023)
				Letter Granting EUA Revision(s) (September 26, 2023)
			QuickFinder COVID-19 Antigen Self Test01/23/2024
			Xiamen Boson Biotech Co., Ltd.
			Rapid SARS-CoV-2 Antigen Test Card 04/06/2022
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (September 2, 2022)
				Letter Granting EUA Revision(s) (October 18, 2022)
				Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (December 22, 2022)
				Letter Granting EUA Revision(s) (May 5, 2023)
				Letter Granting EUA Revision(s) (December 21, 2023)
				Letter Granting EUA Revision(s) (January 23, 2024)
			None02/21/2023
			Watmind USA
			Speedy Swab Rapid COVID-19 Antigen Self-Test
			07/08/2022
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Repeat Testing Revision Letter - November 1, 2022
				Letter Granting EUA Revision(s) (January 17, 2023)
				Letter Granting EUA Revision(s) (February 21, 2023)
			None04/11/2023
			Genabio Diagnostics Inc.
			Genabio COVID-19 Rapid Self-Test Kit
			07/08/2022
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (August 23, 2022)
				Repeat Testing Revision Letter - November 1, 2022
			None06/09/2023
			SEKISUI Diagnostics, LLC.
			OSOM COVID-19 Antigen Home Test
			11/17/2022
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			None
			None04/13/2023
			Beijing Hotgen Biotech Co., Ltd.
			Hotgen COVID-19 Antigen Home Test
			11/17/2022
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (April 13, 2023)
			None03/16/2023
			CorDX, Inc.
			CorDx COVID-19 Ag Test
			11/21/2022
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (March 16, 2023)
			None11/21/2022
			Azure Biotech Inc.
			Fastep COVID-19 Antigen Home Test
			11/21/2022
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			None
			None12/06/2022
			ACON Laboratories, Inc.
			Flowflex COVID-19 Antigen Rapid Test 12/06/2022
			Lateral Flow, Visual Read, Serial Screening, Single Target
			H, M, W
			HCP, Patients, IFU
			None
			None12/20/2022
			CTK Biotech, Inc.
			ImmuView COVID-19 Antigen Home Test
			12/20/2022
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			None
			None12/22/2022
			Oceanit Foundry LLC
			ASSURE-100 Rapid COVID-19 Home Test 12/22/2022
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			None
			None01/03/2024
			Advin Biotech Inc.
			Advin COVID-19 Antigen Test @Home 12/22/2022
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (September 19, 2023)
				Letter Granting EUA Revision(s) (January 03, 2024)
			None02/17/2023
			GenBody Inc.
			GenBody COVID-19 Ag Home Test
			02/17/2023
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			None
			None09/20/2023
			Biosynchronicity Corporation
			C-Sync COVID-19 Antigen Test 03/24/2023
			Lateral Flow, Visual Read, Serial Screening, Multiple Targets
			H, M, W
			HCP, Patient, IFU
			Letter Granting EUA Revision(s) (July 24, 2023)
				Letter Granting EUA Revision(s) (September 20, 2023)
			None04/14/2023
			Azure Biotech, Inc.
			Azure FaStep® COVID-19 Antigen Pen Home Test 
			04/14/2023
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			None
			None06/28/2023
			Princeton BioMeditech Corp.
			Status COVID-19 Antigen Rapid Test for Home Use
			04/24/2023
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (June 28, 2023)
			None05/12/2023
			Nano-Ditech Corporation
			Nano-Check COVID-19 Antigen At-Home Test
			05/12/2023
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			None
			None09/20/2023
			BioTeke USA, LLC
			Bio-Self COVID-19 Antigen Home Test
			05/22/2023
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			Letter Granting EUA Revision(s) (September 20, 2023)
			None07/17/2023
			Immunostics Inc.
			Swab-N-Go Home Test COVID-19 Ag 07/17/2023
			Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
			Home, H, M, W
			HCP, IFU, IFU (Home Test)
			None
			None09/08/2023
			Princeton BioMeditech Corp.
			ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test 09/08/2023
			Lateral Flow, Visual Read, Multi-analyte, Single Target
			H, M, W
			HCP, Patient, IFU
			None
			None09/29/2023
			SD Biosensor, Inc.
			STANDARD Q COVID-19 Ag Test 2.0
			09/29/2023
			Lateral Flow, Visual Read, Serial Screening, Single Target
			H, M, W
			HCP, Patients, IFU
			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.

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 revision also required the EUA holder to 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

Antigen EUA Revisions for Serial (Repeat) Testing

On November 1, 2022, the FDA revised the authorized uses and required updates to product labeling regarding repeat, or serial, testing, for all currently authorized SARS-CoV-2 antigen tests.  The revised Letter of Authorization establishes one additional Condition of Authorization and also eliminates one Condition of Authorization that is no longer needed.

This action is in response to available data about the performance of COVID-19 antigen tests showing that repeat testing after a negative COVID-19 antigen test result increases the chance of an accurate result in people with and without symptoms and could help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. The FDA communicated recommendations consistent with this revision in the August 11, 2022, Safety Communication: At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative.

The November 1, 2022 revision requires test developers in the scope of the revision to take certain actions, including submitting a supplemental EUA request to the FDA with updated labeling to reflect the revised authorized uses, as follows:

Where a test was previously authorized for testing of symptomatic individuals (for example, within the first [number specific to each test] days of symptom onset), the test is now authorized for use at least twice over three days with at least 48 hours between tests.
	Where a test was previously authorized for testing of asymptomatic individuals (for example, individuals without symptoms or other epidemiological reasons to suspect COVID-19), the test is now authorized for use at least three times over five days with at least 48 hours between tests.Repeat Testing Revision Letter - November 1, 2022

                                                                                  Content current as of:
      01/25/2024
              
              
Regulated Product(s)
		 Medical DevicesHealth Topic(s)
			  CoronavirusCOVID-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
 
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