Authorized Tests for COVID-19 and Multiplex Diagnostics

The list below includes lab, point-of-care, and over-the-counter/at-home tests and test products with emergency use authorization (EUA) or traditional marketing authorization from the U.S. Food and Drug Administration (FDA). The organization name and link to the authorization letter from the FDA are provided.

Authorized tests are organized by the type of test (molecular or antigen), use setting.

• An antigen test, frequently used for rapid testing, detects viral proteins found in SARS-CoV-2. Results are usually available in 30 minutes or less. Most over-the-counter COVID-19 tests are antigen tests.
• A molecular test detects the genetic material of SARS-CoV-2. This test is usually conducted at the point-of-care or a sample is collected and sent to a lab for processing. Delivery of results can range from 30 minutes to several days depending on sample processing.
• A multiplex test may be an antigen or molecular test that detects more than one virus such SARS-CoV-2 and influenza.

Tests with FDA Traditional Marketing Authorization

Healgen Rapid Check COVID-19/Flu A&B Antigen Test - Over the counter (OTC)*

*Authorization supported through the RADx® Independent Test Assessment Program (ITAP)

Over-the-counter Tests - Antigen - Multiplex

CorDX, Inc. *

iHealth Labs, Inc. *

OSANG, LLC *

SEKISUI Diagnostics, LLC *

Watmind, USA *

Wondfo USA Co., Ltd. *

*EUA supported through the RADx® Independent Test Assessment Program (ITAP)

Point-of-care Tests - Antigen - Multiplex

CorDx, Inc. *

Healgen *

iHealth Labs, Inc .*

OSANG, LLC.*

SEKISUI Diagnostics, Inc .*

Watmind USA *

Wondfo USA Co. Ltd. *

*EUA supported through the RADx® Independent Test Assessment Program (ITAP)

Point-of-care tests - Molecular - Multiplex

Lucira by Pfizer *

Visby Medical, Inc. *

*EUA supported through the RADx® Independent Test Assessment Program (ITAP)

Over-the-counter Tests - Molecular - Multiplex Over-the-Counter Tests - Antigen

ANP Technologies, Inc. *

Azure Biotech, Inc. *

Azure Biotech, Inc. Antigen Pen Home Test *

CorDx, Inc.

Ellume USA, LLC

GenBody Inc. *

Maxim Biomedical *

Mologic, Inc. *

OSANG, LLC *

Princeton BioMeditech *

Quidel: QuickVue At-Home (screening)

Quidel: QuickVue At-Home

SD Biosensor distributed by Roche *

Siemens *

Watmind USA *

Xiamen Boson Biotech Co., Ltd .*

*EUA supported through the RADx® Independent Test Assessment Program (ITAP)

Refer to this FDA information about how to use and store at-home COVID-19 tests properly.

Refer to this FDA information about extended expiration dates for at-home COVID-19 tests.

Point-of-Care Tests - Antigen

ANP Technologies

Becton, Dickinson and Company, SARS + Flu

GenBody

Princeton Biomeditech

Qorvo Biotechnologies , LLC

Quidel: Sofia 2 Flu + SARS

Quidel: QuickVue SARS

Quidel: Sofia SARS

Xtrava Inc. dba Xtrava Health

Point-of-Care Tests - Molecular

ADL Diagnostics, Inc., dba Anavasi Diagnostics

MicroGem US, Inc.

Minute Molecular Diagnostics, Inc.

Uh-Oh Labs, Inc.

*EUA supported through the RADx® Independent Test Assessment Program (ITAP)

Lab Tests - Antigen

Ellume

Lab Tests - Molecular

Helix OpCo

Helix OpCo (sequencing)

Illumina, Inc.

Meridian Biosciences

Pathogen Dx

University of California, Los Angeles /Octant

Test Products

Ceres

Ceres

Test with Prior EUA - includes OTC, POC, and Lab-based

Becton, Dickinson and Company

Becton, Dickinson and Company

Broad Institute

Detect

Fluidigm Corp., Inc .

Luminostics

Mammoth Biosciences

MatmaCorp Inc.

PathGroup

Quanterix

Sonic Healthcare

Talis Biomedical

Thermo Fisher (formerly Mesa Biotech)

Visby Medical

Visby Medical (pooling)