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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

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.

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