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List of FDA Antigen Diagnostic Tests for EUA for Covid-19

Click below to learn more about FDA authorized at home Covid tests from the source of this information:

FDA.Gov

FDA, Emergency Use Authorization, Antigen Diagnostic Tests:

CareStart COVID-19 Antigen Home Test 08/02/2021

Access Bio, Inc.

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

Becton, Dickinson and Company (BD)

SCoV-2 Ag Detect Rapid Self-Test 11/22/2021

InBios International Inc.

GenBody COVID-19 Ag 07/13/2021

GenBody Inc.

VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack 01/11/2021

Ortho Clinical Diagnostics, Inc.

INDICAID COVID-19 Rapid Antigen Test 7/28/2021

PHASE Scientific International, Ltd.

QuickVue SARS Antigen Test 12/18/2020

Quidel Corporation

BinaxNOW COVID-19 Antigen Self Test 03/31/20

Abbott Diagnostics Scarborough, Inc.

iHealth COVID-19 Antigen Rapid Test 11/05/2021

iHealth Labs, Inc.

InteliSwab COVID-19 Rapid Test 06/04/2021

OraSure Technologies, Inc.

LumiraDx SARS-CoV-2 Ag Test 08/18/2020

LumiraDx UK Ltd.

Status COVID-19/Flu A&B 02/04/2021

Princeton BioMeditech Corp.

Celltrion DiaTrust COVID-19 Ag Home Test 10/21/2021

Celltrion USA, Inc.

QuickVue At-Home OTC COVID-19 Test 03/31/2021

Quidel Corporation

Flowflex COVID-19 Antigen Home Test 10/04/2021

ACON Laboratories, Inc

SPERA COVID-19 Ag Test 10/12/2021

Xtrava Health

NIDS COVID-19 Antigen Rapid Test Kit 09/24/2021

ANP Technologies, Inc

Simoa SARS-CoV-2 N Protein Antigen Test 01/05/2021

Quanterix Corporation

SCoV-2 Ag Detect Rapid Test 05/06/2021


InBios International, Inc.

Celltrion DiaTrust COVID-19 Ag Rapid Test 04/16/2021

Celltrion USA, Inc.

QIAreach SARS-CoV-2 Antigen 08/05/20

QIAGEN GmbH

CareStart COVID-19 Antigen test 10/08/2020

Access Bio, Inc.

LIAISON SARS-CoV-2 Ag 03/26/2021

DiaSorin, Inc.

ellume.lab COVID Antigen Test 07/08/2021

Ellume Limited

InteliSwab COVID-19 Rapid Test Rx 06/04/2021

OraSure Technologies, Inc.

InteliSwab COVID-19 Rapid Test Pro 06/04/2021

OraSure Technologies, Inc.

Sienna-Clarity COVID-19 Antigen Rapid Test Cassette 05/20/2021

Salofa Oy

BinaxNOW COVID-19 Ag Card 08/26/2020

Abbott Diagnostics Scarborough, Inc.

BD Veritor System for Rapid Detection of SARS-CoV-2 07/02/2020

Becton, Dickinson and Company (BD)

Omnia SARS-CoV-2 Antigen Test 04/13/2021

Qorvo Biotechnologies, LLC.

BinaxNOW COVID-19 Ag Card Home Test 12/16/2020

Abbott Diagnostics Scarborough, Inc.

BinaxNOW COVID-19 Ag Card 2 Home Test 03/31/2021

Abbott Diagnostics Scarborough, Inc.

BinaxNOW COVID-19 Ag 2 Card 03/31/2021

Abbott Diagnostics Scarborough, Inc.

BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B 03/24/2021

Becton, Dickinson and Company (BD)

QuickVue At-Home COVID-19 Test 03/01/2021

Quidel Corporation

Ellume COVID-19 Home Test 12/15/2020

Ellume Limited

Clip COVID Rapid Antigen Test 12/07/2020

Luminostics, Inc.

Sampinute COVID-19 Antigen MIA 10/23/2020

Celltrion USA, Inc.

Sofia 2 Flu + SARS Antigen FIA 10/02/2020

Quidel Corporation

Dates listed above indicate when the emergency use authorization was originally issued**

Source: FDA.Gov

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