In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2
In Vitro Diagnostic EUAs: Overview and Templates
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).
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) |
---|---|---|---|---|---|---|---|
04/01/2021 | 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 | |
04/15/2021 | LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 Ag Test 08/18/2020 |
Microfluidic Immunofluorescence Assay, Instrument Read | 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 | None |
04/15/2021 | 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 | 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 | 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 | 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 | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | None |
12/22/2020 | Quidel Corporation | QuickVue SARS Antigen Test 12/18/2020 |
Lateral Flow, Visual Read | H, M, W | HCP, Patients, IFU | None | None |
01/05/2021 | Quanterix Corporation | Simoa SARS-CoV-2 N Protein Antigen Test 01/05/2021 |
Paramagnetic Microbead-based Immunoassay | 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 | None |
02/04/2021 | Princeton BioMeditech Corp. | Status COVID-19/Flu 02/04/2021 |
Lateral Flow, Visual Read, Multi-analyte | H, M, W | HCP, Patients, IFU | None | 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 | 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 | None | None |
03/31/2021 | 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 | None |
04/01/2021 | 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 | HCP, Individuals, IFU, IFU (Home Test) | None | 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 | None |
03/26/2021 | DiaSorin, Inc. | LIAISON SARS-CoV-2 Ag 03/26/2021 |
CLIA | H, M | HCP, Patients, IFU | None | 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 | None |
05/11/2021 | 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 |
05/06/2021 | 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 |
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.