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  7. In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2
  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

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

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Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2

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

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)
06/24/2022 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) None
07/13/2022 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 Home, H, M, W HCP, IFU, IFU (Home Test) None
07/08/2022 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 Home, H, M, W HCP, IFU, IFU (Home Test) GoToKnow COVID-19 Antigen Rapid Test
06/23/2022 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) None None
07/13/2022 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) On/Go One COVID-19 Antigen Home Test
09/24/2021 ANP Technologies, Inc NIDS COVID-19 Antigen Rapid Test Kit 09/24/2021 Lateral Flow, Visual Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU None None
03/25/2022 Becton, Dickinson and Company (BD)

BD Veritor At-Home COVID-19 Test
8/24/2021

Lateral Flow, Digital Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, Individuals, IFU, IFU (Home Test) None None
06/11/2021 Quidel Corporation Sofia SARS Antigen FIA
05/08/2020
Lateral Flow, Fluorescence, Instrument Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU  None
12/10/2021 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 None
07/21/2022 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  None
02/04/2022 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card
08/26/2020
Lateral Flow, Visual Read, Single Target H, M, W HCP, Patients, IFU  None
10/02/2020 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  None
12/02/2021 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 

None

10/23/2020 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 None
03/04/2022 Luminostics, Inc. Clip COVID Rapid Antigen Test
12/07/2020
Lateral flow immunoluminescent assay, instrument read, Single Target H, M, W HCP, Patients, IFU None
07/13/2022 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 None
05/06/2022 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, IndividualsIFU, IFU (Home Test) None
11/09/2021 Quidel Corporation QuickVue SARS Antigen Test
12/18/2020
Lateral Flow, Visual Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU None None
11/16/2021 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 None
10/27/2021 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 None
03/01/2021 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)  None
03/24/2021 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 None
07/21/2022 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, Individuals, IFUIFU (Home Test)  CVS Health At Home COVID-19 Test Kit
05/05/2022 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, Individuals, IFU, IFU (Home Test) None
02/04/2022 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag 2 Card
03/31/2021
Lateral Flow, Visual Read, Non-prescription Testing, Serial Screening, Single Target H, M, W HCP, Patients, IFU None
02/16/2022 DiaSorin, Inc. LIAISON SARS-CoV-2 Ag
03/26/2021
CLIA, Single Target H, M HCP, Patients, IFU  None
07/29/2022 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 None
05/16/2022 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 None None
05/26/2022 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 None
06/09/2022 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 
  • 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 Cassette
08/03/2022 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)  None
08/03/2022 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, Individuals, IFU, IFU (Home Test)  None
08/03/2022 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  None
07/08/2021 Ellume Limited ellume.lab COVID Antigen Test
07/08/2021
Lateral Flow, Fluorescence, Instrument Read, Single Target H, M, W HCP, Patients, IFU None None
06/13/2022 GenBody Inc. GenBody COVID-19 Ag
07/13/2021
Lateral Flow, Visual Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU None
05/12/2022 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 None
06/07/2022 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 HCPIFU, IFU (Home Test) On/Go COVID-19 Antigen Self-Test
05/27/2022 QIAGEN GmbH QIAreach SARS-CoV-2 Antigen
08/05/2021
Digital Lateral Flow, Fluorescence, Instrument Read, Single Target H, M HCP, Patients, IFU None None
10/12/2021 Xtrava Health SPERA COVID-19 Ag Test
10/12/2021
Lateral Flow, Visual Read, Single Target H, M, W HCP, Patients, IFU None None
06/29/2022 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) None
02/01/2022 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 None
8/5/2022 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) None
01/14/2022 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 None None
07/22/2022 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) None
05/04/2022 Oceanit Foundry LLC ASSURE-100 Rapid COVID-19 Test
02/28/2022
Lateral Flow, Visual Read, Single Target H, M, W HCP, Patients, IFU None
05/24/2022 Siemens Healthcare Diagnostics, Inc. Atellica IM SARS-CoV-2 Antigen (CoV2Ag)
03/11/2022
CLIA, Single Target H, M HCP, Patients, IFU None None
05/24/2022 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag)
03/11/2022
CLIA, Single Target H, M HCP, Patients, IFU None None
07/13/2022 OSANG LLC OHC COVID-19 Antigen Self Test 04/06/2022 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None None
06/01/2022 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, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None None
07/08/2022 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, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None None
07/08/2022 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) 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 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

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