In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2
In Vitro Diagnostic EUAs: Overview and Templates
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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).
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) |
---|---|---|---|---|---|---|---|
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 | 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 | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
09/24/2021 | ANP Technologies, Inc | NIDS COVID-19 Antigen Rapid Test Kit 09/24/2021 | Lateral Flow, Visual Read, Serial Screening | H, M, W | HCP, Patients, IFU | None | None |
08/24/2021 | Becton, Dickinson and Company (BD) |
BD Veritor At-Home COVID-19 Test |
Lateral Flow, Digital Read, Over the Counter (OTC) Home Testing, Serial Screening | 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 | H, M, W | HCP, Patients, IFU | None | |
04/14/2021 | 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 | H, M, W | HCP, Patients, IFU | None | |
10/29/2021 | LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 Ag Test 08/18/2020 |
Microfluidic Immunofluorescence Assay, Instrument Read, Screening | H, M, W | HCP, Patients, IFU | None | |
04/20/2021 | Abbott Diagnostics Scarborough, Inc. | BinaxNOW COVID-19 Ag Card 08/26/2020 |
Lateral Flow, Visual Read | 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 | H, M, W | HCP, Patients, IFU | None | |
07/16/2021 | Access Bio, Inc. | CareStart COVID-19 Antigen test 10/08/2020 |
Lateral Flow, Visual Read, Serial Screening | 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) | H, M | HCP, Patients, IFU | None | |
12/07/2020 | Luminostics, Inc. | Clip COVID Rapid Antigen Test 12/07/2020 |
Lateral flow immunoluminescent assay, instrument read | H, M, W | HCP, Patients, IFU | 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 | Home, H, M, W | HCP, IFU, IFU (Home Test), FAQ | None | |
04/12/2021 | Abbott Diagnostics Scarborough, Inc. | BinaxNOW COVID-19 Ag Card Home Test 12/16/2020 |
Lateral Flow, Visual Read, Prescription Home Testing, Telehealth Proctor Supervised | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
07/26/2021 | Quidel Corporation | QuickVue SARS Antigen Test 12/18/2020 |
Lateral Flow, Visual Read, Serial Screening | H, M, W | HCP, Patients, IFU | None | None |
09/10/2021 | Quanterix Corporation | Simoa SARS-CoV-2 N Protein Antigen Test 01/05/2021 |
Paramagnetic Microbead-based Immunoassay, Serial Screening, Saliva |
H, M | HCP, Patients, IFU | None | None |
03/16/2021 | Ortho Clinical Diagnostics, Inc. | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack 01/11/2021 |
Chemiluminescence Immunoassay, Instrument Read | 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 | 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 | 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 | H, M, W | HCP, Patients, IFU 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 | Home, H, M, W | HCP, Individuals, IFU, IFU (Home Test) | None | |
08/10/2021 | 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 | Home, H, M, W | HCP, Individuals, IFU, IFU (Home Test) | None | None |
03/31/2021 | 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 | Home, H, M, W | None | ||
03/31/2021 | Abbott Diagnostics Scarborough, Inc. | BinaxNOW COVID-19 Ag 2 Card 03/31/2021 |
Lateral Flow, Visual Read, Non-prescription Testing, Serial Screening | H, M, W | HCP, Patients, IFU | None | |
07/12/2021 | DiaSorin, Inc. | LIAISON SARS-CoV-2 Ag 03/26/2021 |
CLIA | H, M | HCP, Patients, IFU | None | |
04/13/2021 | Qorvo Biotechnologies, LLC. | Omnia SARS-CoV-2 Antigen Test 04/13/2021 |
Bulk Acoustic Wave (BAW) Biosensor, Instrument Read | H, M | HCP, Patients, IFU | None | |
09/01/2021 | Celltrion USA, Inc. | Celltrion DiaTrust COVID-19 Ag Rapid Test 04/16/2021 |
Lateral Flow, Visual Read, Serial Screening | 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 | H, M, W | HCP, Patients, IFU | None | None |
05/20/2021 | Salofa Oy | Sienna-Clarity COVID-19 Antigen Rapid Test Cassette 05/20/2021 |
Lateral Flow, Visual Read | H, M, W | HCP, Patients, IFU | None | |
06/04/2021 | OraSure Technologies, Inc. | InteliSwab COVID-19 Rapid Test Rx 06/04/2021 |
Lateral Flow, Visual Read, Prescription Home Testing | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
11/01/2021 | OraSure Technologies, Inc. | InteliSwab COVID-19 Rapid Test 06/04/2021 |
Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening | Home, H, M, W | HCP, Individuals, IFU, IFU (Home Test) | None | |
06/04/2021 | OraSure Technologies, Inc. | InteliSwab COVID-19 Rapid Test Pro 06/04/2021 |
Lateral Flow, Visual Read, Serial Screening | 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 | H, M, W | HCP, Patients, IFU | None | None |
09/24/2021 | GenBody Inc. | GenBody COVID-19 Ag 07/13/2021 |
Lateral Flow, Visual Read | H, M, W | HCP, Patients, IFU | None | None |
07/28/2021 | PHASE Scientific International, Ltd. | INDICAID COVID-19 Rapid Antigen Test 07/28/2021 |
Lateral Flow, Visual Read | H, M, W | HCP, Patients, IFU | None | None |
08/23/2021 | Access Bio, Inc. | CareStart COVID-19 Antigen Home Test 08/02/2021 |
Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening | Home, H, M, W | HCP, Individuals, IFU, IFU (Home Test) | Letter Granting EUA Revision(s) (August 23, 2021) |
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 | H, M | HCP, Patients, IFU | None | None |
10/12/2021 | Xtrava Health | SPERA COVID-19 Ag Test 10/12/2021 |
Lateral Flow, Visual Read | 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 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.