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In Vitro Diagnostic EUAs: Overview and Templates

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

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).

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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.

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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) 01/05/2022 SD Biosensor, Inc. 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 None 12/22/2021 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) None None 10/21/2021 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 10/19/2021 ACON Laboratories, Inc Flowflex COVID-19 Antigen Home Test 10/04/2021 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test)

Letter Granting EUA Revision(s) (October 15, 2021)

None 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 11/23/2021 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

Letter Granting EUA Amendment(s) (June 9, 2020)
Letter Granting EUA Amendment(s) (July 17, 2020)
Viral Mutation Revision Letter – September 23, 2021

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

Letter Granting EUA Amendment(s) (July 23, 2020)
Letter Granting EUA Revision(s) (December 10, 2021)

None 10/29/2021 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 Ag Test 08/18/2020 Microfluidic Immunofluorescence Assay, Instrument Read, Screening, Single Target H, M, W HCP, Patients, IFU

Letter Granting EUA Revision(s) (January 26, 2021)
Viral Mutation Revision Letter – September 23, 2021

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

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)

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

Viral Mutation Revision Letter – September 23, 2021

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

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)

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

Viral Mutation Revision Letter – September 23, 2021

None 12/07/2020 Luminostics, Inc. Clip COVID Rapid Antigen Test 12/07/2020 Lateral flow immunoluminescent assay, instrument read, Single Target H, M, W HCP, Patients, IFU

Viral Mutation Revision Letter – September 23, 2021

None 02/11/2021 Ellume Limited Ellume COVID-19 Home Test 12/15/2020 Lateral Flow, Fluorescence, Instrument Read, Over the Counter (OTC) Home Testing, Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test), FAQ

Viral Mutation Revision Letter – September 23, 2021

None 02/04/2022 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, Single Target Home, H, M, W HCP, Individuals, IFU, IFU (Home Test)

Viral Mutation Revision Letter – September 23, 2021
Letter Granting EUA Revision(s) (January 7, 2022)

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 12/21/2021 Quanterix Corporation Simoa SARS-CoV-2 N Protein Antigen Test 01/05/2021

Paramagnetic Microbead-based Immunoassay, Serial Screening, Saliva, Single Target

H, M 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

Viral Mutation Revision Letter – September 23, 2021
Letter Granting EUA Revision(s) (November 16, 2021)

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

Viral Mutation Revision Letter – September 23, 2021

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)

Viral Mutation Revision Letter – September 23, 2021

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

Viral Mutation Revision Letter – September 23, 2021

None 10/21/2021 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, IFU, IFU (Home Test)

Viral Mutation Revision Letter – September 23, 2021

None 01/07/2022 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)

Letter Granting EUA Revision(s) (January 7, 2022)

None 01/07/2022 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card 2 Home Test 03/31/2021 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Telehealth Proctor Supervised, Serial Screening, Single Target Home, H, M, W

HCP, Individuals, IFU, IFU (Home Test)

Viral Mutation Revision Letter – September 23, 2021
Letter Granting EUA Revision(s) (January 7, 2022)

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

Viral Mutation Revision Letter – September 23, 2021
Letter Granting EUA Revision(s) (January 7, 2022)

None 07/12/2021 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

None 04/13/2021 Qorvo Biotechnologies, LLC. Omnia SARS-CoV-2 Antigen Test 04/13/2021 Bulk Acoustic Wave (BAW) Biosensor, Instrument Read, Single Target H, M HCP, Patients, IFU

Viral Mutation Revision Letter – September 23, 2021

None 09/01/2021 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 09/03/2021 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 None 12/17/2021 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)

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

01/27/2022 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)

Viral Mutation Revision Letter – September 23, 2021

None 01/27/2022 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)

Viral Mutation Revision Letter – September 23, 2021

None 01/27/2022 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

Viral Mutation Revision Letter – September 23, 2021

None 07/08/2021 Ellume Limited daypg.com COVID Antigen Test 07/08/2021 Lateral Flow, Fluorescence, Instrument Read, Single Target H, M, W HCP, Patients, IFU None None 11/17/2021 GenBody Inc. GenBody COVID-19 Ag 07/13/2021 Lateral Flow, Visual Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU None None 01/14/2022 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

Letter Granting EUA Revision(s) (January 14, 2022)

None 01/22/2022 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 HCP, IFU, IFU (Home Test)

Letter Granting EUA Revision(s) (August 23, 2021)
Letter Granting EUA Revision(s) (January 22, 2022)

On/Go COVID-19 Antigen Self-Test 08/05/2021 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 01/25/2022 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 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

Letter Granting EUA Revision(s) (Feburary 1, 2022)

None 02/09/2022 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 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 01/19/2022 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 None

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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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