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  1. COVID-19 Emergency Use Authorizations for Medical Devices

In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2

March 24, 2023 - The FDA has finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for:

  • Developing a transition implementation plan,
  • Submitting a marketing submission, and
  • Taking other actions with respect to these devices.

The FDA encourages stakeholders to review the two final guidances, view the webinar, and reach out to the FDA if they have questions or concerns. In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.

Additional Resources:

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Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2

The table below includes information about authorized SARS-CoV-2 molecular diagnostic tests. These emergency use authorizations (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 the EUA.

For information on test EUAs that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD).

In addition to COVID-19 tests issued EUAs, there are molecular SARS-CoV-2 diagnostic tests that have been authorized through traditional premarket review pathways.

Tests with "single target" in the attribute column are:

  • designed to detect only one viral target on the SARS-CoV-2 genome;
  • more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants.

Tests with "multiple targets" in the attribute column are:

  • designed to detect two or more viral targets, or sections of the SARS-CoV-2 genome;
  • more likely to continue to perform well when new variants emerge.

EUAs for standalone specimen collection devices, including home collection kits which do not include an assay in the EUA, will not have a target designation in the attribute column.

Authorized Molecular Diagnostic Tests for SARS-CoV-2 are assigned the QJR product code.

Authorized Home Collection Kits are assigned the QLW product code. Authorized EUAs for Multi-analyte Respiratory Panel Tests are assigned the QLT product code.

Date EUA Issued or Last Updated Entity Diagnostic (Most Recent Letter of Authorization) and Date EUA Original Issue Attributes3 Authorized Setting(s)1 Authorization Documents2 Other Documents Other Brand Name(s)
05/14/2024 3EO Health, Inc. 3EO Health COVID-19 Test 09/19/2023 RT, LAMP, Over the Counter (OTC) Home Testing, Multiple Targets Home, H, M, W HCP, Individuals, IFU, IFU Home None
06/08/2023 Michigan State University laboratories, Department of Medicine Olin Student Health Center In-Dx SARS-CoV-2 RT-LAMP Assay 06/08/2023 RT-LAMP, Single Target H HCP, Patients, EUA Summary None None
06/05/2023 Acutis Diagnostics  SARS-CoV-2 Acutis Multiplex Assay 06/05/2023 real-time RT-PCR, Multiple Targets H HCP, Patient, EUA Summary None None
04/26/2023 University of Massachusetts ICTC SARS-CoV-2 RT-PCR Assay 4/26/2023 real-time RT-PCR, Multiple Targets H HCP, Patient, EUA Summary None None
03/26/2024 Nanobiosym Precision Testing Services The Nano Test for COVID-19 11/08/2022 Real-time RT-PCR, Home Collection, Saliva, Multiple Targets H HCP, Patients, EUA Summary, IFU None None
04/12/2024 Aptitude Medical Systems Inc. Metrix COVID-19 Test 10/18/2022 RT, LAMP, Over the Counter (OTC) Home Testing, Saliva, Screening, Multiple Targets Home, H, M, W HCP, IFUIFU (Home Test) None
09/13/2022 Predicine, Inc. Predicine SARS-CoV-2 RT-PCR Test 07/19/2022 Real-time RT-PCR, Home Collection, Multiple Targets, Screening, Pooling H HCP, Patients, EUA SummaryIFU (Home Collect) None None
07/28/2022 Laboratory Corporation of America (Labcorp) Labcorp Seasonal Respiratory Virus RT-PCR DTC Test 05/16/2022 Direct to Consumer (DTC), Real-time RT-PCR, Multi-analyte, Home Collection, Single Target H HCP, Individuals, EUA SummaryIFU (Home Collect) None
04/26/2022 Audere HealthPulse@home Fusion 04/26/2022 Home Collection Kit, Screening, Single Target N/A EUA Summary, IFU None None
12/17/2021 UCSD BCG EXCITE Lab UCSD EXCITE COVID-19 Test 12/17/2021 Real-time RT-PCR, Home Collection, Screening, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect)  None None
08/24/2022 Applied BioCode, Inc. BioCode CoV-2 Flu Plus Assay 
12/15/2021
RT-PCR, Multi-analyte, Single Target H HCP, Patients, IFU None
07/21/2022 Meridian Bioscience, Inc. Revogene SARS-CoV-2
11/09/2021
Real time RT-PCR, Single Target H, M HCP, Patients, IFU None None
01/26/2024 Revvity, Inc. Respiratory SARS-CoV-2 RT-PCR Panel 1
10/06/2021
Real-time RT-PCR, Multi-analyte, Multiple Targets H HCP, Patients, IFU None
10/19/2022 Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute SelfCheck cobas SARS-CoV-2 Assay
09/29/2021
Real-time RT-PCR, Home Collection, Screening, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None None
12/14/2021 Quest Diagnostics Nichols Institute Quest Diagnostics Collection Kit for COVID-19
10/08/2021
Home Collection Kit N/A EUA Summary, IFU None None
07/28/2022 Laboratory Corporation of America (Labcorp) Labcorp SARS-CoV-2 & Influenza A/B Assay
9/30/2021
Real-time RT-PCR, Multi-analyte, Home Collection, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None
07/18/2023 Cepheid Xpert Xpress CoV-2/Flu/RSV plus 09/10/2021 Real-time RT-PCR, Multi-analyte, Multiple Targets H, M, W HCP, Patients, IFU for Labs, IFU for Point-of-Care None
07/01/2024 SalivaDirect, Inc. SalivaDirect for use with DTC Kits 08/27/2021 Direct to Consumer (DTC), Real-time RT-PCR, Saliva, Home Collection, Screening, Pooling, Single Target H HCP, Individuals, EUA Summary None
07/01/2024 SalivaDirect, Inc. SalivaDirect DTC Saliva Collection Kit
08/27/2021
Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening N/A IndividualEUA Summary None None
08/25/2021 Empire City Laboratories ECL COVID TEST SYSTEM-1 08/25/2021 Real-time RT-PCR, Home Collection, Multiple Targets H HCP, Patients, IFU (Home Collect), EUA Summary None None
08/25/2021 Empire City Laboratories ECL COVID TEST SYSTEM 08/25/2021 Real-time RT-PCR, Home Collection, Multiple Targets H HCP, Patients, IFU (Home Collect), EUA Summary None None
08/23/2021 The Mount Sinai Hospital, Center for Clinical Laboratories Mount Sinai SARS-CoV-2 Assay 08/23/2021 Real-time RT-PCR, Home Collection, Saliva, Screening, Multiple Targets H HCP, Patients, IFU (Home Collect), EUA Summary None None
01/11/2022 SEASUN BIOMATERIALS U-TOP COVID-19 Detection Kit
04/27/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
03/30/2023 SD Biosensor, Inc. STANDARD M nCoV Real-Time Detection Kit
04/23/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
11/15/2022 altona Diagnostics GmbH RealStar SARS-CoV02 RT-PCR Kits U.S.
04/22/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
03/07/2023 Centers for Disease Control and Prevention's (CDC) CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC)
02/04/2020
Real-time RT-PCR, Pooling, Multiple Targets H HCP, Patients, IFU None
05/20/2021 Wadsworth Center, New York State Department of Public Health New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel
02/29/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
04/26/2022 BGI Genomics Co. Ltd Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2
03/26/2020
Real-time RT-PCR, Single Target H HCP, Patients, IFU None
04/26/2022 Cepheid Xpert Xpress SARS-CoV-2 test
03/20/2020
Real-time RT-PCR, Multiple Targets H, M, W HCP, Patients, IFU for Labs,
IFU for Point-of-Care
None
01/05/2021 Primerdesign Ltd. Primerdesign Ltd COVID-19 genesig Real-Time PCR assay
03/20/2020
Real-time RT-PCR, Single Target H HCP, Patients, IFU None
08/18/2020 GenMark Diagnostics, Inc. ePlex SARS-CoV-2 Test
03/19/2020
RT-PCR and electrochemical detection, Multiple Targets H, M HCP, Patients, IFU None
07/22/2021 DiaSorin Molecular LLC Simplexa COVID-19 Direct assay
03/19/2020
Real-time RT-PCR, Multiple Targets H, M HCP, Patients, IFU None
06/28/2022 Abbott Molecular Inc. Abbott RealTime SARS-CoV-2 assay
03/18/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
03/10/2023 Quest Diagnostics Nichols Institute Quest SARS-CoV-2 rRT-PCR
03/17/2020
Real-time RT-PCR, Home Collection, Pooling, Multiple Targets, Screening (Anterior Nasal) H HCP, Patients, IFU None
04/17/2023 Quidel Corporation Lyra SARS-CoV-2 Assay
03/17/2020
Real-time RT-PCR, Single Target H HCP, Patients, IFU None
06/21/2022 Laboratory Corporation of America (Labcorp) COVID-19 RT-PCR Test
03/16/2020
Real-time RT-PCR, Home Collection, Pooling, Screening, Multiple Targets H HCP, Patients, EUA
Summary
, IFU (Home Collect)
None
03/23/2022 Hologic, Inc. Panther Fusion SARS-CoV-2 Assay
03/16/2020
Real-time RT-PCR, Pooling, Screening, Multiple Targets H HCP, Patients, IFU None
08/31/2022 Thermo Fisher Scientific, Inc. TaqPath COVID-19 Combo Kit
03/13/2020
Real-time RT-PCR, Home Collection, Multiple Targets H HCP, Patients, IFU None
02/08/2023 Roche Molecular Systems, Inc. (RMS) cobas SARS-CoV-2
03/12/2020
Real-time RT-PCR, Pooling, Screening, Multiple Targets H, M, H-Pooling HCP, Patients, IFU None
05/31/2022 BioFire Defense, LLC BioFire COVID-19 Test
03/23/2020
RT, Nested multiplex PCR, Pooling, Saliva, Multiple Targets H, M HCP, Patients, IFU None
01/31/2024 Revvity, Inc. New Coronavirus Nucleic Acid Detection Kit
03/24/2020
Real-time RT-PCR, Pooling, Saliva, Multiple Targets H HCP, Patients, IFU None
10/04/2022 Avellino Lab USA, Inc. AvellinoCoV2 test
03/25/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
10/19/2022 Luminex Molecular Diagnostics, Inc. NxTAG CoV Extended Panel Assay
03/27/2020
RT-PCR, Multiple Targets H HCP, Patients, IFU None
08/27/2021 Abbott Diagnostics Scarborough, Inc. ID NOW COVID-19
03/27/2020
RT, Isothermal amplification, Single Target H, M, W HCP, Patients, IFU None
07/29/2021 QIAGEN GmbH QIAstat-Dx Respiratory SARS-CoV-2 Panel
03/30/2020
Real-time RT-PCR, Multi-analyte, Multiple Targets H, M HCP, Patients, IFU None None
01/22/2021 NeuMoDx Molecular, Inc. NeuMoDx SARS-CoV-2 Assay
03/30/2020
RT-PCR, Collection Kit, Saliva, Multiple Targets H, M HCP, Patients, IFU, IFU (Collect) None
03/15/2023 Ipsum Diagnostics, LLC COV-19 IDx assay
04/01/2020
Real-time RT-PCR, Single Target H HCP, Patients, EUA Summary None
03/14/2023 Co-Diagnostics, Inc. Logix Smart Coronavirus Disease 2019 (COVID-19) Kit
04/03/2020
RT-PCR, CoPrimer technology, Single Target H HCP, Patients, IFU None
03/27/2023 Luminex Corporation ARIES SARS-CoV-2 Assay
04/03/2020
RT-PCR, Multiple Targets H, M HCP, Patients, IFU None
04/28/2020 Gnomegen LLC Gnomegen COVID-19 RT-Digital PCR Detection Kit
04/06/2020
Real-time RT-digital PCR, Multiple Targets H HCP, Patients, IFU None
05/21/2021 InBios International, Inc Smart Detect SARS-CoV-2 rRT-PCR Kit
04/07/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
01/11/2022 DiaCarta, Inc QuantiVirus SARS-CoV-2 Test kit
04/08/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
07/14/2022 Becton, Dickinson and Company (BD) BD SARS-CoV-2 Reagents for BD MAX System
04/08/2020
Real-time RT-PCR, Screening, Multiple Targets H, M HCP, Patients, IFU None
12/28/2020 Atila BioSystems, Inc. iAMP COVID-19 Detection Kit
04/10/2020
RT, Isothermal amplification, Multiple Targets H HCP, Patients, IFU None
03/09/2023 Maccura Biotechnology (USA) LLC SARS-CoV-2 Fluorescent PCR Kit
04/15/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
04/16/2020 GenoSensor, LLC GS"¢ COVID-19 RT-PCR KIT
04/16/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
02/15/2023 Fosun Pharma USA Inc. Fosun COVID-19 RT-PCR Detection Kit
04/17/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
02/24/2023 OSANG Healthcare GeneFinder COVID-19 Plus RealAmp Kit
04/18/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
08/08/2020 Trax Management Services Inc. PhoenixDx 2019-CoV
04/20/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
12/13/2022 Seegene, Inc. Allplex 2019-nCoV Assay
04/21/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
03/01/2023 LabGenomics Co., Ltd. LabGun COVID-19 RT-PCR Kit
04/29/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
09/13/2022 Rheonix, Inc. Rheonix COVID-19 MDx Assay
04/29/2020
RT-PCR, Home Collection, Saliva, Single Target H, M HCP, Patients, IFU, IFU (Home Collect) None
03/25/2022 Sansure BioTech Inc. Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
05/04/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
11/01/2022 OPTI Medical Systems, Inc. OPTI SARS-CoV-2 RT PCR Test
05/06/2020
Real-time RT-PCR, Screening, Pooling, Multiple Targets H HCP, Patients, IFU None
02/18/2022 Sherlock BioSciences, Inc. Sherlock CRISPR SARS-CoV-2 Kit
05/06/2020
RT-LAMP, CRISPR, Multiple Targets H HCP, Patients, IFU None
08/18/2021 Infinity BiologiX LLC Infinity BiologiX TaqPath SARS-CoV-2 Assay
04/10/2020
Real-time RT-PCR, Home Collection, Saliva, Pooling, Multiple Targets H

HCP, Patients, IFU (Home Collect), EUA Summary

  • Vault Health COVID-19 Test
  • USGC Saliva Test Kit, hims/hers Saliva Test Kit
  • BioIQ COVID-19 Saliva Test
  • Concentric by Ginkgo
  • 1health.io Zero Contact
  • Base10 Saliva Test Kit
  • Purlab. Saliva Test Kit
  • Reliant Saliva Test Kit
  • E7 Health Saliva Test Kit
  • miinehealth Saliva Test Kit
  • Maverick Saliva Test Kit
  • SDTL Saliva Test Kit
  • AZOVA At-Home COVID-19 Test Collection Kit
  • Wellness 4 Humanity SDNA-1000 Saliva Collection Kit
02/14/2022 Zymo Research Corporation Quick SARS-CoV-2rRT-PCR Kit
05/07/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
05/08/2020 Gnomegen LLC Gnomegen COVID-19-RT-qPCR Detection Kit
05/08/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
12/09/2022 1drop Inc. 1copy COVID-19 qPCR Multi Kit
05/11/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
06/28/2022 Abbott Molecular Inc. Alinity m SARS-CoV-2 assay
05/11/2020
Real-time RT-PCR, Pooling, Screening, Multiple Targets H, M HCP, Patients, IFU None
08/30/2023 Hologic, Inc. Aptima SARS-CoV-2 assay
05/14/2020
TMA, chemiluminescent, Pooling, Screening, Multiple Targets H HCP, Patients, IFU None
10/12/2022 GeneMatrix, Inc. NeoPlex COVID-19 Detection Kit
05/14/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
06/22/2021 Fulgent Therapeutics Fulgent COVID-19 by RT-PCR Test
05/15/2020
Real-time RT-PCR, Home Collection, Screening, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None
03/02/2023 Everlywell, Inc. Everlywell COVID-19 Test Home Collection Kit
05/15/2020
Home Collection Kit N/A IFU, EUA Summary None
02/23/2022 Assurance Scientific Laboratories Assurance SARS-CoV-2 Panel
05/15/2020
Real-time RT-PCR, Home Collection, Multiple Targets H HCP, Patients, EUA Summary None
05/25/2021 Quidel Corporation Lyra Direct SARS-CoV-2 Assay
05/18/2020
Real-time RT-PCR, Single Target H HCP, Patients, IFU None
04/01/2021 P23 Labs, LLC. P23 Labs TaqPath SARS-CoV-2 Assay
05/21/2020
Real-time RT-PCR, Home Collection, Saliva, Multiple Targets H HCP, Patients, IFU1 (Home Collect), IFU2 (Home Collect)  EUA Summary
  • AZOVA P23 At-Home COVID-19 Test Collection Kit
  • binx health (powered by P23) At-home Saliva COVID-19 Test Collection Kit for the Group Setting
01/05/2022 Seasun Biomaterials, Inc. AQ-TOP COVID-19 Rapid Detection Kit
05/21/2020
RT-LAMP, Single Target H HCP, Patients, IFU None
12/28/2020 SolGent Co., Ltd DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit
05/21/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
08/18/2021 INVITES BIOCORE CO., LTD. BioCore 2019-nCoV Real Time PCR Kit
05/21/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
02/01/2022 LetsGetChecked, Inc. LetsGetChecked Coronavirus (COVID-19) Test
05/28/2020
Direct to Consumer (DTC), TMA, chemiluminescent, Home Collection, Screening, Pooling, Multiple Targets H HCP, Individuals, EUA Summary, IFU (Home Collect) None
05/17/2021 Phosphorus Diagnostics LLC Phosphorus COVID-19 RT-qPCR Test
06/04/2020
Real-time RT-PCR, Home Collection, Saliva, Screening, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect), IFU (Clinic)
  • Wheeler Labs COVID-19 RT-qPCR Test
03/03/2023 Genetron Health (Beijing) Co., Ltd. Genetron SARS-CoV-2 RNA Test
06/05/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
04/13/2022 Euroimmun US, Inc. EURORealTime SARS-Cov-2
06/08/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
01/19/2022 Illumina, Inc. Illumina COVIDSeq Test
06/09/2020
Sequencing, Multiple Targets H HCP, Patients, IFU None
05/12/2023 DTPM, Inc. DTPM COVID-19 RT-PCR Test
06/10/2020
Real-time RT-PCR, Single Target H HCP, Patients, IFU None
08/27/2021 TBG Biotechnology Corp. ExProbe SARS-CoV-2 Testing Kit
06/10/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
03/01/2022 Cue Health Inc. Cue COVID-19 Test
06/10/2020
RT, Isothermal amplification, Single Target H, M, W HCP, Patients, IFU None
06/08/2021 Applied BioCode, Inc. BioCode SARS-CoV-2 Assay
06/15/2020
RT-PCR, Pooling, Multiple Targets H HCP, Patients, IFU None
01/13/2022 Kaiser Permanente Mid-Atlantic States KPMAS COVID-19 Test
06/13/2020
Real-time RT-PCR, Home Collection, Screening, Multiple Targets H HCP, Patients, EUA SummaryIFU (Home Collect) None
05/10/2021 Jiangsu Bioperfectus Technologies Co., Ltd. COVID-19 Coronavirus Real Time PCR Kit
06/18/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
06/17/2020 The Ohio State University Wexner Medical Center OSUWMC COVID-19 RT-PCR test
06/17/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
06/24/2021 3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd. TRUPCR SARS-CoV-2 Kit
06/18/2020
Real-time RT-PCR, Saliva, Multiple Targets H HCP, Patients, IFU None
09/21/2020 HealthQuest Esoterics HealthQuest Esoterics TaqPath SARS-CoV-2 Assay
06/23/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
06/23/2020 University of Alabama at Birmingham Fungal Reference Lab FRL SARS CoV-2 Test
06/23/2020
Real-time RT-PCR, Single Target H HCP, Patients, EUA Summary None
08/26/2021 Gencurix, Inc. GenePro SARS-CoV-2 Test
06/23/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None None
01/29/2021 Diagnostic Solutions Laboratory, LLC DSL COVID-19 Assay
06/25/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
01/06/2022 PreciGenome LLC FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR)
06/25/2020
RT-digital droplet PCR, Multiple Targets H HCP, Patients, IFU None
04/26/2022 PlexBio Co., Ltd. IntelliPlex SARS-CoV-2 Detection Kit
06/25/2020
RT-PCR, Multiple Targets H HCP, Patients, IFU None
06/26/2020 Inform Diagnostics, Inc. Inform Diagnostics SARS-CoV-2 RT-PCR Assay
06/26/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
09/24/2020 Acupath Laboratories, Inc. Acupath COVID-19 Real-Time (RT-PCR) Assay
06/29/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
01/26/2022 Psomagen, Inc. Psoma COVID-19 RT Test
06/30/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
05/28/2021 BioTNS Co. Ltd. COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit
06/30/2020
RT-PCR, Multiple Targets H HCP, Patients, IFU None
05/19/2021 The Kroger Co. Kroger Health COVID-19 Test Home Collection Kit
06/30/2020
Home Collection Kit, Direct to Consumer (DTC), Screening N/A Individuals, IFU, EUA Summary None
08/05/2021 Centers for Disease Control and Prevention (CDC) Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay
07/02/2020
Real-time RT-PCR, Multi-analyte, Single Target H HCP, Patients, IFU None
02/13/2023 Enzo Life Sciences, Inc. AMPIPROBE SARS-CoV-2 Test System
07/07/2020
Real-time RT-PCR, Pooling, Multiple Targets H HCP, Patients, IFU

None

02/05/2021 Access Bio, Inc. CareStart COVID-19 MDx RT-PCR
07/07/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU
  • KarmaCare COVID-19 MDx RT-PCR
  • AQGene COVID-19 MDx RT-PCRv
12/28/2020 Gene By Gene Gene By Gene SARS-CoV-2 Detection Test
07/07/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
07/09/2020 UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin SARS-CoV-2 RNA DETECTR Assay
07/09/2020
RT-LAMP, Single Target H HCP, Patients, EUA Summary None
12/28/2020 BioSewoom, Inc. Real-Q 2019-nCoV Detection Kit
07/09/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
01/04/2022 KogeneBiotech Co., Ltd. PowerChek 2019-nCoV Real-time PCR Kit
07/13/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None None
11/01/2022 Trax Management Services Inc. PhoenixDx SARS-CoV-2 Multiplex
07/13/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
07/13/2020 Compass Laboratory Services, LLC Compass Laboratory Services SARS-CoV2 Assay
07/13/2020
Real-time RT-PCR, Home Collection, Single Target H HCP, Patients, EUA Summary None
03/10/2023 Quest Diagnostics Nichols Institute Quest Diagnostics PF SARS-CoV-2 Assay
07/15/2020
Real-time RT-PCR, Home Collection, Multiple Targets, Screening H HCP, Patients, EUA Summary None
03/10/2023 Quest Diagnostics Nichols Institute Quest Diagnostics RC SARS-CoV-2 Assay
07/15/2020
Real-time RT-PCR, Home Collection, Pooling, Multiple Targets, Screening H HCP, Patients, EUA Summary None
12/14/2021 Quest Diagnostics Nichols Institute Quest Diagnostics HA SARS-CoV-2 Assay
07/15/2020
TMA, chemiluminescent, Home Collection, Multiple Targets H HCP, Patients, EUA Summary None
09/21/2020 Boston Heart Diagnostics Boston Heart COVID-19 RT-PCR Test
07/16/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
07/28/2021 Access Genetics, LLC OraRisk COVID-19 RT-PCR
07/17/2020
Real-time RT-PCR, Home Collection, Single Target H HCP, Patients, EUA Summary None None
01/20/2022 DiaCarta, Inc. QuantiVirus SARS-CoV-2 Multiplex Test Kit
07/21/2020
Real-time RT-PCR, Single Target H HCP, Patients, IFU None
10/22/2020 Helix OpCo LLC Helix COVID-19 Test
07/23/2020
Real-time RT-PCR, Home Collection, Screening, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None
07/24/2020 Jiangsu CoWin Biotech Co., Ltd. Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)
07/24/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
07/09/2021 Color Health, Inc. Color SARS-CoV-2 RT-LAMP Diagnostic Assay
05/18/2020
RT, LAMP, Home Collection, Screening, Multiple Targets H HCP, Patients, EUA Summary None
09/21/2020 Eli Lilly and Company Lilly SARS-CoV-2 Assay
07/27/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
01/29/2021 Sandia National Laboratories SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay
07/27/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
07/30/2020 Clinical Reference Laboratory, Inc. CRL Rapid Response
07/30/2020
Real-time RT-PCR, Home Collection, Saliva, Single Target H

HCP, Patients, EUA Summary, IFU (Home Collect)

None
02/27/2023 Xiamen Zeesan Biotech Co., Ltd. SARS-CoV-2 Test Kit (Real-time PCR)
07/31/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
07/31/2020 University of California San Diego Health UCSD RC SARS-CoV-2 Assay
07/31/2020
Real-time RT-PCR, Pooling, Multiple Targets H HCP, Patients, EUA Summary None
06/17/2021 WREN Laboratories LLC WREN Laboratories COVID-19 PCR Test
08/03/2020
Real-time RT-PCR, Home Collection, Saliva, Screening, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None
09/21/2020 Ethos Laboratories Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay
08/03/2020
RT-PCR and MALDI-TOF Mass Spec., Home Collection, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None
08/03/2020 Poplar Healthcare Poplar SARS-CoV-2 TMA Pooling assay
08/03/2020
TMA, chemiluminescent, Pooling, Multiple Targets H HCP, Patients, EUA Summary None
07/14/2021 ISPM Labs, LLC dba Capstone Healthcare Genus SARS-CoV-2 Assay
08/03/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None None
08/06/2020 Helix OpCo LLC (dba Helix) Helix COVID-19 NGS Test
08/06/2020
Sequencing, Single Target H HCP, Patients, EUA Summary None
06/24/2021 Vela Operations Singapore Pte Ltd ViroKey SARS-CoV-2 RT-PCR Test
08/05/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
01/06/2022 George Washington University Public Health Laboratory GWU SARS-CoV-2 RT-PCR Test
08/07/2020
Real-time RT-PCR, Multiple Targets, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect) None
12/28/2020 Solaris Diagnostics Solaris Multiplex SARS-CoV-2 Assay
08/10/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
01/28/2021 Alpha Genomix Laboratories Alpha Genomix TaqPath SARS-CoV-2 Combo Assay
08/10/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
03/24/2023 Biomeme, Inc. Biomeme SARS-CoV-2 Real-Time RT-PCR Test
08/11/2020
Real-time RT-PCR, Pooled Serial Screening - Swab, Pooled Serial Screening - Media, Multiple Targets H HCP, Patient, IFU None
07/18/2023 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 RNA STAR
08/11/2020
RT, non-isothermal nucleic acid amplification qSTAR, Single Target H HCP, Patient, IFU None
05/28/2021 Pro-Lab Diagnostics Pro-AmpRT SARS-CoV-2 Test
08/13/2020
RT, Isothermal amplification, Single Target H HCP, Patient, EUA Summary None
07/01/2024 SalivaDirect, Inc. SalivaDirect
08/15/2020
Real-time RT-PCR, Saliva, Home Collection, Screening, Pooling, Single Target H HCP, Patients, EUA Summary None
08/17/2020 ZhuHai Sinochips Bioscience Co., Ltd. COVID-19 Nucleic Acid RT-PCR Test Kit
08/17/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
12/09/2020 DxTerity Diagnostics, Inc. DxTerity SARS-CoV-2 RT-PCR Test
08/21/2020
Real-time RT-PCR, Saliva, Multiple Targets H HCP, Patients, EUA Summary None
06/14/2023 Texas Department of State Health Services, Laboratory Services Section Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay
08/21/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
02/08/2021 QDx Pathology Services QDX SARS-CoV-2 Assay
08/25/2020
Real-time RT-PCR, Home Collection, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None
10/02/2020 Cuur Diagnostics Cuur Diagnostics SARS-CoV-2 Molecular Assay
08/26/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
09/21/2020 Patients Choice Laboratories, LLC PCL SARS-CoV-2 Real-Time RT-PCR Assay
08/28/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
02/17/2023 DxTerity Diagnostics, Inc. DxTerity SARS-CoV-2 RT PCR CE Test
08/28/2020
RT-PCR, Home Collection, Saliva, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None
12/28/2020 T2 Biosystems, Inc. T2SARS-CoV-2 Panel
08/31/2020
RT, amplification, T2 Magnetic resonance, Single Target H, M HCP, Patients, IFU None
05/27/2022 MiraDx MiraDx SARS-CoV-2 RT-PCR assay
08/31/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
01/28/2021 BayCare Laboratories, LLC BayCare SARS-CoV-2 RT PCR Assay
08/31/2020
Real-time RT-PCR, Pooling, Multiple Targets H HCP, Patients, EUA Summary None
06/17/2021 MobileDetect Bio Inc. MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit
09/01/2020
RT-LAMP, Multiple Targets H, M HCP, Patients, IFU None
12/28/2020 OPTOLANE Technologies, Inc. Kaira 2019-nCoV Detection Kit
09/01/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
07/21/2022 Color Health, Inc. Color COVID-19 Self-Swab Collection Kit
08/31/2020
Home Collection Kit, Screening, Multiple Targets N/A EUA Summary, IFU None
03/31/2023 Bioeksen R&D Technologies Inc. Bio-Speedy Direct RT-qPCR SARS-CoV-2
09/02/2020
Real-time RT-PCR, Single Target H HCP, Patients, IFU
  • BioeXsen SARS-CoV-2 RT PCR
02/10/2023 Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B
09/03/2020
Real-time RT-PCR, Multi-analyte, Multiple Targets H, M HCP, Patients, IFU None
10/31/2020 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. Wantai SARS-CoV-2 RT-PCR Kit
09/09/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
08/27/2021 GK Pharmaceuticals Contract Manufacturing Operations GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT
09/18/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
07/15/2021 KimForest Enterprise Co., Ltd. KimForest SARS-CoV-2 Detection Kit v1
09/21/2020
Real-time RT-PCR, Single Target H HCP, Patients, IFU None
05/06/2021 Quadrant Biosciences Inc. Clarifi COVID-19 Test Kit
09/22/2020
Real-time RT-PCR, Saliva, Pooling, Multiple Targets H HCP, Patients, IFU None
06/12/2023 Vela Operations Singapore Pte. Ltd. ViroKey SARS-CoV-2 RT-PCR Test v2.0
09/22/2020
Real-time RT-PCR, Multiple Targets, Pooled Serial Screening – Media H HCP, Patients, IFU None
03/24/2022 Clear Labs, Inc. Clear Dx SARS-CoV-2 Test
09/23/2020
RT-PCR and Sequencing, Multiple Targets H HCP, Patients, IFU None
02/16/2023 Genetrack Biolabs, Inc. Genetrack SARS-CoV-2 Molecular Assay
09/25/2020
Real-time RT-PCR, Home Collection, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None
11/19/2021 Aeon Global Health Aeon Global Health SARS-CoV-2 Assay
09/30/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
01/28/2022 National Jewish Health SARS-CoV-2 MassArray Test
09/29/2020
RT-PCR and MALDI-TOF Mass Spec. , Multiple Targets H HCP, Patients, EUA Summary None
04/02/2021 Alimetrix, Inc. Alimetrix SARS-CoV-2 RT-PCR Assay
09/30/2020
RT-PCR, Microarray Hybridization, Home Collection, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None
03/18/2022 Tempus Labs, Inc. iC SARS-CoV2 Test
10/01/2020
Real-time RT-PCR, Home Collection, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None
12/28/2020 UMass Memorial Medical Center UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel
10/01/2020
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
06/05/2023 BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ)
10/02/2020
RT, Nested multiplex PCR, Multi-analyte, Multiple Targets H, M, W HCP, Patients, IFU None
01/11/2022 SEASUN BIOMATERIALS, Inc. AQ-TOP COVID-19 Rapid Detection Kit PLUS
10/05/2020
RT-LAMP, Multiple Targets H HCP, Patients, IFU None
10/08/2020 University of California, Los Angeles (UCLA) UCLA SwabSeq COVID-19 Diagnostic Platform
10/06/2020
RT-PCR and Sequencing, Single Target H HCP, Patients, EUA Summary None
04/04/2024 GenMark Diagnostics, Inc. ePlex Respiratory Pathogen Panel 2
10/07/2020
RT-PCR and electrochemical detection, Multi-analyte, Multiple Targets H, M HCP, Patients, IFU None
08/04/2021 Spectrum Solutions LLC SDNA-1000 Saliva Collection Device
10/08/2020
Saliva Collection Device N/A EUA Summary, IFU None None
07/10/2023 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 RNA STAR Complete
10/14/2020
RT, qSTAR amplification, Home Collection, Screening, Pooling, Single Target H HCP, Patients, IFU None
06/10/2021 Clinical Enterprise, Inc. EmpowerDX COVID-19 Home Collection Kit DTC
10/15/2020
Home Collection Kit, Direct to Consumer (DTC), Screening N/A EUA Summary, IndividualsIFU None None
01/12/2022 Viracor Eurofins Clinical Diagnostics Viracor SARS-CoV-2 assay
04/06/2020
Real-Time RT-PCR, Pooling, Screening, Pooled Serial Screening - Swab, Multiple Targets H HCP, Patients, EUA Summary None
08/13/2021 binx health, Inc. binx health At-Home Nasal Swab COVID-19 Sample Collection Kit
10/20/2020
Home Collection Kit N/A EUA Summary, IFU None
05/04/2021 Agena Bioscience, Inc. MassARRAY SARS-CoV-2 Panel
10/26/2020
RT-PCR, chip array and MALDI-TOF Mass Spec, Multiple Targets H HCP, Patients, IFU None
10/28/2020 DNA Genotek Inc. ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100 saliva collection devices
10/28/2020
Saliva Collection Device N/A EUA Summary, IFU None None
10/28/2020 DNA Genotek Inc. OMNIgene·ORAL OM-505 and OME-505 (OMNIgene·ORAL) saliva collection devices
10/14/2020
Saliva Collection Device N/A EUA Summary, IFU None None
06/14/2023 Pfizer Inc. Lucira COVID-19 All-In-One Test Kit
11/17/2020
Prescription Home Testing, Multiple Targets Home, H, M, W HCP, IFU, IFU (Home Test) None
01/22/2021 Express Gene LLC, DBA: Express Gene Molecular Diagnostics Laboratory Express Gene 2019-nCoV RT-PCR Diagnostic Panel
05/22/2020
Real-time RT-PCR, Collection Kit, Saliva, Multiple Targets H HCP, Patients, EUA Summary, IFU None
03/03/2022 Diversified Medical Healthcare RapidRona Self-Collection Kit
11/23/2020
Home Collection Kit, Screening N/A EUA Summary, IFU (Collection) None
10/15/2021 Gravity Diagnostics, LLC Gravity Diagnostics SARS-CoV-2 RT-PCR Assay
11/23/2020
Real-time RT-PCR, Home Collection, Saliva, Screening, Multiple Targets H HCP, Patients, EUA Summary None None
11/24/2020 Stanford Health Care Clinical Virology Laboratory SARS-CoV-2 RT-PCR Assay
04/08/2020
Real-time RT-PCR, Home Collection, Single Target H HCP, Patients, EUA Summary, IFU (Home Collection) None
12/14/2021 Quest Diagnostics Nichols Institute Quest Diagnostics RC COVID-19+Flu RT-PCR
12/04/2020
Real-time RT-PCR, Multi-analyte, Home Collection, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collection) None
11/01/2022 Laboratory Corporation of America (LabCorp) Pixel by LabCorp COVID-19 Test Home Collection Kit
12/09/2020
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening, Multiple Targets H HCP, Individuals, EUA Summary, IFU (Home Collect) None
08/12/2022 RCA Laboratory Services LLC dba GENETWORx GENETWORx Covid-19 Nasal Swab Test
12/15/2020
Real-time RT-PCR, Home Collection, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None
12/11/2020 ResearchDx, Inc., DBA Pacific Diagnostics PacificDx Covid-19
12/11/2020
TMA, chemiluminescent, Home Collection, Multiple Targets H HCP, Patients, EUA Summary None
02/14/2023 Hologic, Inc. Aptima SARS-CoV-2/Flu assay
12/16/2020
Real-time TMA, chemiluminescent, Multi-analyte, Multiple Targets H HCP, Patients, IFU None
05/05/2022 Quidel Corporation Solana SARS-CoV-2 Assay
12/23/2020
Isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA), Single Target H, M HCP, Patients, IFU None
10/11/2022 Cepheid Xpert Xpress SARS-CoV-2 DoD
12/23/2020
Real-time RT-PCR, Pooling, Multiple Targets H, M, W HCP, Patients, EUA Summary None
06/08/2022 SML GENETREE Co., Ltd. Ezplex SARS-CoV-2 G Kit
01/13/2021
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
07/16/2021 Ambry Genetics Laboratory Ambry COVID-19 RT-PCR Test
01/22/2021
Real-time RT-PCR, Home Collection, Saliva, Multiple Targets H HCP, Patients, IFU (Home Collect), EUA Summary None
01/19/2021 Hospital of the University of Pennsylvania BD MAX COVID-19 ASSAY (Authorized by HHS/OASH)
01/19/2021
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
09/06/2022 INNO Diagnostics Reference Laboratory, Ponce Medical School PMSF-INNO SARS-CoV-2 RT-PCR Test (Authorized by HHS/OASH)
01/19/2021
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
06/24/2021 Clinomics USA Inc. Clinomics TrioDx RT-PCR COVID-19 Test
02/04/2021
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None
03/20/2023 Thermo Fisher Scientific TaqPath COVID-19, FluA, FluB Combo Kit
02/10/2021
Real-time RT-PCR, Multi-analyte, Multiple Targets H HCP, Patients, IFU None
07/07/2022 Grifols Diagnostic Solutions Inc. Procleix SARS-CoV-2 Assay
02/10/2021
TMA, Single Target H HCP, Patients, IFU None
08/07/2022 Gravity Diagnostics, LLC Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits
02/13/2021
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Multiple Targets H HCP, Individuals, EUA Summary None
02/23/2022 Assurance Scientific Laboratories Assurance SARS-CoV-2 Panel DTC
02/13/2021
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Single Target H HCP, Individuals, EUA Summary, IFU (Home Collect) None
  • binx/Assurance Covid-19 Collection Kit
03/02/2023 Everlywell, Inc. Everlywell COVID-19 Test Home Collection Kit DTC
02/13/2021
Home Collection Kit, Direct to Consumer (DTC), Screening N/A Individuals, EUA Summary, IFU (Home Collect) None None
01/14/2022 University of Illinois Office of the Vice President for Economic Development and Innovation covidSHIELD
02/24/2021
Real-time RT-PCR, Saliva, Serial Screening, Home Collection, Pooling, Multiple Targets H HCP, Patients, EUA Summary IFU (Home Collect) None None
01/19/2022 Viracor Eurofins Clinical Diagnostics Viracor SARS-CoV-2 assay DTC
02/26/2021
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Multiple Targets H HCP, Individuals, EUA Summary None
04/29/2022 Cue Health Inc. Cue COVID-19 Test for Home and Over The Counter (OTC) Use
03/05/2021
RT, Isothermal amplification, Over the Counter (OTC) Home Testing, Single Target Home, H, M, W HCP, Individuals, IFU, IFU (Home Test), FAQ None
06/28/2022 Abbott Molecular Inc. Alinity m Resp-4-Plex
03/04/2021
Real-time RT-PCR, Multi-analyte, Multiple Targets H, M HCP, Patients, IFU None
01/04/2023 Luminex Molecular Diagnostics, Inc. NxTAG Respiratory Pathogen Panel + SARS-CoV-2
03/03/2021
RT-PCR, Multi-analyte, Multiple Targets H HCP, Patients, IFU None
08/07/2022 Gravity Diagnostics, LLC Gravity Diagnostics COVID-19 Test Home Collection Kit
03/09/2021
Home Collection Kit, Direct to Consumer (DTC), Screening N/A EUA Summary, Individuals, IFU None None
01/26/2022 Color Health, Inc. Color COVID-19 Self-Swab Collection Kit DTC
03/19/2021
Home Collection Kit, Direct to Consumer (DTC), Screening N/A EUA Summary, Individuals, IFU None
09/03/2021 Color Health, Inc. Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC
03/19/2021
Direct to Consumer (DTC), RT, LAMP, Home Collection, Screening, Multiple Targets H EUA Summary, Individuals, HCP None None
01/26/2022 STS Lab Holdco (a subsidiary of Amazon.com Services LLC) Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2
03/25/2021
Real-time RT-PCR, Home Collection, Pooling, Screening, Single Target H HCP, Patients, EUA Summary, IFU (Home Collect) None
08/31/2022 University of Louisville Infectious Diseases Laboratory SARS-CoV-2 real time RT-PCR test (Authorized by HHS/OASH)
01/19/2021
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None
06/29/2023 Pfizer Inc. Lucira CHECK-IT COVID-19 Test Kit
04/09/2021
RT, LAMP, Over the Counter (OTC) Home Testing, Screening, Multiple Targets Home, H, M, W HCP, IFU, IFU (Home Test) None
11/04/2022 Thermo Fisher Scientific Inc. Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit
04/09/2021
Real-time RT-PCR, Saliva, Multiple Targets H HCP, Patients, IFU None
06/24/2021 Clinical Enterprise, Inc. Clinical Enterprise SARS-CoV-2 RT-PCR Assay
04/13/2021
Real-time RT-PCR, Screening, Pooled Serial Screening - Swab, Multiple Targets H HCP, Patients, EUA Summary None
04/13/2021 Clinical Enterprise, Inc. Clinical Enterprise SARS-CoV-2 RT-PCR Assay DTC
04/13/2021
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Multiple Targets H HCP, Individuals, EUA Summary None
07/01/2024 SalivaDirect, Inc. SalivaDirect At-Home Collection Kit
04/09/2021
Home Collection Kit, Saliva, Screening N/A EUA Summary None
06/15/2022 Color Health, Inc. Color COVID-19 Self-Swab Collection Kit with Saline
04/14/2021
Home Collection Kit, Screening N/A EUA Summary, IFU None
06/02/2021 Synergy Diagnostic Laboratory, Inc., DBA SynergyDx SynergyDx SARS-CoV-2 RNA Test DTC
04/16/2021
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Multiple Targets H HCP, Individuals, EUA Summary, IFU (Home Collect)  None
06/02/2021 Synergy Diagnostic Laboratory, Inc., DBA SynergyDx SynergyDx SARS-CoV-2 RNA Test
04/16/2021
Real-time RT-PCR, Home Collection, Screening, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None
07/22/2021 PathogenDx, Inc. DetectX-Rv
04/20/2021
RT-PCR, DNA Microarray Hybridization, Multiple Targets H HCP, Patients, IFU None None
05/17/2021 Phosphorus Diagnostics LLC Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC
05/17/2021
Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening, Multiple Targets N/A Individual, EUA Summary, IFU None None
05/17/2021 Phosphorus Diagnostics LLC Phosphorous COVID19 RT-qPCR Test DTC
05/17/2021
Real-time RT-PCR, Direct to Consumer (DTC), Screening, Salvia, Home Collection, Multiple Targets H HCP, Individuals, EUA Summary None
07/08/2021 Harvard University Clinical Laboratory (HUCL) Quaeris SARS-CoV-2 Assay
05/21/2021
Real-time RT-PCR, Home Collection, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None None
06/17/2021 WREN Laboratories LLC WREN Laboratories COVID-19 PCR Test DTC
06/17/2021
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Saliva Screening, Multiple Targets H HCP, Individuals, EUA Summary None
06/17/2021 WREN Laboratories LLC WREN Laboratories COVID-19 Saliva Test Collection Kit DTC
06/17/2021
Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening, Multiple Targets N/A Individuals, EUA Summary, IFU None None
08/02/2023 Roche Molecular Systems cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2)
06/17/2021
Real-time RT-PCR, Screening, Multiple Targets H, M, W HCP, Patients, IFU None
11/01/2022 BioGX, Inc. BioGX Xfree COVID-19 Direct RT-PCR
06/29/2021
Real-time RT-PCR, Single Target H HCP, Patients, IFU None
07/01/2021 Everlywell, Inc. Everlywell COVID-19 & Flu Test Home Collection Kit
07/01/2021
Home Collection Kit, Multi-analyte N/A IFU, EUA Summary None None
03/31/2023 Thermo Fisher Scientific Inc. TaqPath COVID-19 RNase P Combo Kit 2.0
07/08/2021
Real-time RT-PCR, Screening, Home Collection, Multiple Targets H HCP, Patients, IFU None
03/20/2023 Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.) TaqPath COVID-19 Fast PCR Combo Kit 2.0
07/30/2021
Real-time RT-PCR, Saliva, Multiple Targets H HCP, Patients, IFU None
11/29/2021 Kwokman Diagnostics, LLC Kwokman Diagnostics COVID-19 Home Collection Kit
08/13/2021
Home Collection Kit N/A IFU, EUA Summary None None
09/22/2021 Life Sciences Testing Center Life Sciences Testing Center COVID-19 Test
09/22/2021
Real-time RT-PCR, Home Collection, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None None
10/14/2021 LMSI, LLC (dba Lighthouse Lab Services) CovidNow SARS-CoV-2 Assay
10/14/2021
Real-time RT-PCR, Home Collection, Screening, Single Target H HCP, Patients, IFU, IFU (Home Collect) None None
07/19/2022 Audere HealthPulse@home
11/30/2021
Home Collection Kit, Screening, Single Target N/A EUA Summary, IFU None None
04/21/2022 Premier Medical Laboratory Services PMLS SARS-CoV-2 Assay
01/07/2022
Real-time RT-PCR, Home Collection, Screening, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None None
01/25/2024 Uh-Oh Labs Inc. UOL COVID-19 Test
02/08/2022
RT-LAMP, Single Target H, M, W HCP, Patients, IFU None
07/28/2022 Minute Molecular Diagnostics, Inc. DASH SARS-CoV-2/S Test 
03/15/2022
Real-time RT-PCR, Multiple Targets H, M, W HCP, Patients, IFU None
07/14/2022 Helix OpCo LLC (dba Helix) Helix SARS-CoV-2 Test
03/17/2022
Real-time RT-PCR, Home Collection, Multiple Targets, Screening H HCP, Patients, EUA Summary, IFU (Home Collect) None None
07/07/2022 Quest Diagnostics Nichols Institute Quest COVID-19 PCR Test Home Collection Kit
03/21/2022
Direct to Consumer (DTC), Home Collection Kit, Screening N/A EUA Summary, IFU, Individuals None
03/21/2022 Quest Diagnostics Nichols Institute Quest RC COVID-19 PCR DTC
03/21/2022
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Multiple Targets, Screening H HCP, Individuals, EUA Summary None None
03/21/2022 Quest Diagnostics Nichols Institute Quest PF COVID-19 PCR DTC
03/21/2022
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Multiple Targets, Screening H HCP, Individuals, EUA Summary None None
10/06/2022 Quest Diagnostics Nichols Institute Quest COVID-19 PCR DTC
03/21/2022
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Multiple Targets, Screening H HCP, Individuals, EUA Summary None
04/06/2022 DC Department of Health Test Yourself DC At-Home COVID-19 Collection Kit 04/06/2022 Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening, Multiple Targets H HCP, Individuals, EUA Summary, IFU (Home Collect) None None
05/25/2022 UCSD BCG EXCITE Lab UCSD EXCITE COVID-19 EL Test 04/07/2022 Real-time RT-PCR, Home Collection, Screening, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None
08/17/2022 Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute SelfCheck cobas SARS-CoV-2 + Flu Assay 04/11/2022 Real-time RT-PCR, Home Collection, Multi-analyte, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None
08/24/2022 MicroGEM U.S., Inc. MicroGEM Sal6830 SARS-CoV-2 Saliva Test
04/14/2022
Real-time RT-PCR, Saliva, Multiple Targets H, M, W HCP, Patients, IFU None
04/21/2022 OPTI Medical Systems, Inc. OPTI SARS-CoV-2/ Influenza A/B RT-PCR Test (Version 1 and Version 2) 
04/21/2022
Real-time RT-PCR, Multi-analyte, Multiple Targets H HCP, Patients, IFU None None
05/24/2023 Abbott Diagnostics Scarborough, Inc. ID NOW COVID-19 2.0
05/06/2022
RT, Isothermal amplification, Single Target H, M, W HCP, Patients, IFU None
11/07/2022 Cepheid Xpert Xpress CoV-2 plus
05/10/2022
Real-time RT-PCR, Screening, Multiple Targets H, M, W HCP, PatientsIFU for LabsIFU for Point-of-Care None None
07/28/2022 Laboratory Corporation of America (Labcorp) Labcorp Seasonal Respiratory Virus RT-PCR Test
05/17/2022
Real-time RT-PCR, Multi-analyte, Home Collection, Single Target H HCP, Patients, EUA Summary, IFU (Home Collect) None
07/21/2022 Nexus Medical Labs, LLC Nexus High Throughput SARS-CoV-2 Assay
05/17/2022
Real-time RT-PCR, Home Collection, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None
08/09/2023 DxLab Inc. DxLab COVID-19 Test
06/01/2022
RT-LAMP, Serial Screening, Multiple Targets H, M, W HCP, Patients, IFU None
06/14/2022 Roche Molecular Systems, Inc. cobas SARS-CoV-2 Duo for use on the cobas 6800/8800 Systems
06/14/2022
Real-time RT-PCR, Quantitative, Multiple Targets H, M HCP, Patients, IFU None None
11/18/2022 Premier Medical Laboratory Services Diversified Medical Healthcare SARS-CoV-2 Assay
11/18/2022
Real-time RT-PCR, Home Collection, Screening, Multiple Targets H HCP, Patients, EUA Summary, IFU (Home Collect) None None
09/06/2023 Pfizer Inc. Lucira by Pfizer COVID-19 & Flu Test 11/22/2022 RT-LAMP, Multiple Targets, Multi-analyte H, M, W HCP, Patients, IFU None
12/19/2022 OnsiteGene, Inc. Hi-Sense COVID-19 Molecular Testing Kit 1.0 
12/19/2022
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None None
08/16/2023 Visby Medical, Inc. Visby Medical Respiratory Health Test
12/23/2022
RT-PCR, Multi-analyte, Multiple Targets H, M, W HCP, Patients, IFU None None
06/30/2023 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete Assay 
02/03/2023
RT, Non-isothermal Nucleic Acid Amplification qSTAR, Multi-analyte, Single Target H HCP, Patients, IFU None
04/16/2024 ADL Diagnostics, Inc., dba Anavasi Diagnostics The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector
02/08/2023
RT-LAMP, Multiple Targets H, M, W HCP, Patients, IFU None
02/08/2023 The HFI Laboratory at Boston University (dba the BU Clinical Testing Laboratory) BU SARS-CoV-2 Test
02/08/2023
real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None None
12/14/2023 Pfizer Inc. Lucira by Pfizer COVID-19 & Flu Home Test
02/24/2023
RT, LAMP, Over the Counter (OTC) Home Testing, Multi-analyte, Multiple Targets Home, H, M, W HCP, IFU, IFU (Home Test) None
03/10/2023 Quest Diagnostics Nichols Institute Quest COVID-19 Nucleic Acid Test Collection Kit
03/10/2023
Home Collection Kit, Screening N/A EUA Summary, IFU None None
04/19/2023 MedArbor, LLC dba MedArbor Diagnostics MedArbor Diagnostics SARS-CoV-2 Assay
04/19/2023
real-time RT-PCR, Single Target H HCP, Patients, EUA Summary None None
05/03/2023 Access Medical Laboratories, Inc. Global Direct RT-PCR Test
05/03/2023
real-time RT-PCR, Single Target H HCP, Patients, EUA Summary None None
06/30/2023 Discover Labs Discover Labs COVID-19 Assay
06/30/2023
Real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None None
07/20/2023 Alphadera Labs, LLC ALPHADx SARS-COV-2 RT-PCR Test
07/20/2023
Real-time RT-PCR, Multiple Target(s) H HCP, Patients, EUA Summary None None
10/13/2023 MAWD Laboratories MAWD Laboratories SARS-CoV-2 Dual Target by RT-PCR
10/13/2023
real-time RT-PCR, Multiple Targets H HCP, Patients, EUA Summary None None
11/16/2023 Roche Molecular Systems cobas SARS-CoV-2 & Influenza A/B v2
11/16/2023
Real-time RT-PCR, Multiple Targets, Multi-analyte H, M HCP, Patients, IFU None None
12/08/2023 RCA Laboratory Services LLC dba GENETWORx Gx HTIQ SARS-CoV-2 Test
12/08/2023
Real-time RT-PCR, Single Target, Screening H HCP, Patients, EUA Summary None None
12/08/2023 RCA Laboratory Services LLC dba GENETWORx Gx HTKB SARS-CoV-2 Test
12/08/2023
Real-time RT-PCR, Single Target, Screening H HCP, Patients, EUA Summary None None
03/19/2024 Tetracore, Inc. EZ-SARS-CoV-2 Real-Time RT-PCR
03/19/2024
Real-time RT-PCR, Multiple Targets H HCP, Patients, IFU None None
04/01/2024 LMSI, LLC d/b/a Lighthouse Lab Services SalivaNow SARS-CoV-2 Assay
04/01/2024
Real-time RT-PCR, Saliva, Single Target H HCP, Patients, IFU None None
06/07/2024 Roche Molecular Systems, Inc. cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test 06/07/2024 RT-PCR, Multiple Targets, Multi-analyte 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.

3 Abbreviations:

  • RT-PCR = reverse transcriptase polymerase chain reaction;
  • RT = reverse transcriptase;
  • LAMP = loop-mediated isothermal amplification;
  • MALDI-TOF = Matrix Assisted Laser Desorption/Ionization - Time of Flight;
  • TMA = Transcription Mediated Amplification;
  • qSTAR = Selective Temperature Amplification Reaction;
  • CRISPR = clustered regularly interspaced short palindromic repeats;

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. 


Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2

On April 20, 2021, the FDA issued an amendment allowing certain authorized molecular diagnostic SARS-CoV-2 tests to be distributed and used to pool anterior nasal respiratory specimens from asymptomatic individuals as part of a serial testing program after developers submit a complete notification, including meeting required validation data, as set forth in the letter. Use of tests for these indications is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, except that tests authorized for use in specific named or designated high complexity laboratories can only be used in such laboratories.

This means that tests with EUAs that are amended by this authorization may be used with pooled anterior nasal specimens from individuals without known or suspected COVID-19 when such individuals are tested as part of a testing program that includes testing at regular intervals, at least once per week. The indications in each appendix (A-H) differ in the number of specimens that can be pooled (up to 3, up to 5, or up to 10) and the type of pooling that can be done (media pooling or swab pooling).

Prior to a test being distributed or used for any new indication, the developer must submit a notification to the FDA with the information required by the amendment, including self-certifying that the applicable validation has been completed. Tests will be added to Exhibit 1 once FDA confirms that the required documentation has been submitted. Please note that being added to Exhibit 1 does not necessarily mean that the FDA has reviewed the underlying validation data submitted or confirmed that the test is appropriately validated.

Exhibit 1 of the Pooling and Serial Testing Amendment

The table below includes information for the authorized RT-PCR molecular diagnostic tests for SARS-CoV-2 amended by this Pooling and Serial Testing Amendment. For authorization documents for each test, see Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2 above.

Date Added to Exhibit 1 EUA Holder Test Name Indication(s)*
06/24/2021 Clinical Enterprise, Inc. Clinical Enterprise SARS-SoV-2-RT-PCR Assay Swab: Up to 10 (Appendix C)
06/22/2021 Biomeme, Inc. Biomeme SARS-CoV-2 Real-Time RT-PCR Test Swab: Up to 10 (Appendix C)
Media: Up to 10 (Appendix H)
06/23/2021 Viracor Eurofins Clinical Diagnostics Viracor SARS-CoV-2 assay Swab: Up to 10 (Appendix C)
01/28/2022 Vela Operations Singapore Pte. Ltd ViroKey SARS-CoV-2 RT-PCR Test v2.0 Media: Up to 3 (Appendix D)

* The indications in each appendix (A-H) differ in the number of specimens that can be pooled (up to 3, up to 5, or up to 10) and the type of pooling that can be done (media or swab pooling). 

Tests authorized for Swab Pooling are authorized for:

  • Qualitative detection of RNA from SARS-CoV-2 in pooled samples containing up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swabs placed in a single vial containing transport media after being collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from any individual, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week as part of a serial testing program.

    This indication is authorized for use in laboratories certified under CLIA to perform high complexity tests except tests authorized for use in specific named or designated laboratories can only be used in such laboratories.

Tests authorized for Media Pooling are authorized for:

  • Qualitative detection of RNA from SARS-CoV-2 in pooled samples containing aliquots of transport media from up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swab specimens that were collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from any individual and placed in individual vials containing transport media, including individuals without symptoms or other reasons to suspect COVID-19, when tested as part of a serial testing program including testing at least once per week.

    This indication is authorized for use in laboratories certified under CLIA to perform high complexity tests except tests authorized for use in specific named or designated laboratories can only be used in such laboratories.


Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing

On November 15, 2021, the FDA issued an umbrella EUA for certain RT-PCR molecular-based tests, developed by laboratories, for detection of nucleic acid from SARS-CoV-2 from anterior nasal respiratory specimens for use as part of a serial testing program, that meet certain criteria for eligibility specified in the EUA. Under this EUA, authorized tests can be used with individual or pooled anterior nasal specimens for testing individuals, including individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least once per week. This means that tests authorized by this EUA may be used with individual or pooled anterior nasal respiratory specimens from individuals with or without known or suspected exposure to COVID-19 when such individuals are tested at least once per week, such as testing at regular intervals as part of a testing program implemented by schools, workplaces, or community groups. The indications in each appendix (A-K) differ in the number of specimens that can be pooled (1, up to 3, up to 5, or up to 10), the type of pooling that can be done (media pooling or swab pooling), and whether the test can be used with home collected specimens.

Use of tests authorized by this EUA is limited to use in the single laboratory that developed the authorized test and that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets requirements to perform high complexity tests. 

Tests will be added to Exhibit 1 of this EUA following submission of a complete notification to the FDA with the information required by the EUA, including self-certifying that the applicable validation has been completed, and confirmation by the FDA that the required documentation has been submitted. Being added to Exhibit 1 does not necessarily mean that the FDA has reviewed the underlying validation data submitted or confirmed that the test is appropriately validated.

Exhibit 1 of the Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing

This exhibit includes information for the RT-PCR molecular diagnostic tests for SARS-CoV-2 authorized by this umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing. All tests authorized by this umbrella EUA are required to have at least two viral targets on the SARS-CoV-2 genome. Tests with multiple targets are more likely to continue to perform well when new variants emerge.

Date Added
to Exhibit 1
EUA Holder Test Name Additional Indication(s)* Authorization Documents**
08/01/2022 Helix Diagnostics Helix Diagnostics SARS nCoV-2019 Multiplexed Assay None Test Summary, HCP, Patients
01/05/2023 Scope Molecular Laboratory Scope Molecular Laboratory SARS nCoV-2019 Multiplexed Assay None Test Summary, HCP, Patients
10/06/2023 Rize Laboratory Rize Laboratory SARS nCoV-2019 Multiplexed Assay Appendix E Test Summary, HCP, Patients

* All tests authorized under this Umbrella EUA are authorized for (as described in appendix A):

  • Qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swab samples collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from individuals, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week.
     
    Each test is authorized for use in the single laboratory that developed the authorized test and that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets requirements to perform high complexity tests.

Additional indications included in appendices (B-K) differ in the number of specimens that can be pooled (up to 3, up to 5, or up to 10), the type of pooling that can be done (media or swab pooling), and the inclusion of use with home collected specimens. 

Tests authorized for Swab Pooling (appendices B-D) are authorized for:

  • Qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swabs or pooled samples containing up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swabs placed in a single vial after being collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from individuals, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week.
     
    This test is authorized for use in the single laboratory that developed the test and that is certified under CLIA and meets requirements to perform high complexity tests.

Tests authorized for Media Pooling (appendices E-I) are authorized for:

  • Qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swabs or pooled samples containing aliquots of media from up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swab specimens that were collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from individuals, including individuals without symptoms or other reasons to suspect COVID-19 and placed in individual vials when tested at least once per week.
     
    This test is authorized for use in the single laboratory that developed the test and that is certified under CLIA and meets requirements to perform high complexity tests.

Tests authorized for Home Specimen Collection (appendices J-K) are authorized for the applicable above indications with the following addition regarding specimen collection:

  • {or self-collected at home using the following authorized home collection kit(s): [specific named home collection kit(s) with which the test was validated] when used consistent with the home collection kit's authorization for individuals tested at least once per week}

** Authorization Documents include the Test Summary, Fact Sheet for Healthcare Providers (HCP) and Fact Sheet for Patients.


EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests

On March 31, 2020, the FDA issued an umbrella EUA for molecular laboratory developed tests (LDTs) for detection of SARS-CoV-2 that meet certain criteria for eligibility described in the EUA. Under this EUA, authorized tests are authorized for use in the single laboratory that developed the authorized test and that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.  Tests authorized under this umbrella EUA were added to Appendix A in the table below. 

On November 15, 2021, the FDA reissued this EUA such that only tests that are listed in Appendix A are authorized for use as described in the EUA, and no additional tests will be authorized by this EUA.  The reissued EUA also includes updated Conditions of Authorization and Fact Sheets to reflect the most up-to-date information.

Appendix A: Authorized Molecular-Based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2

The table below includes information for the high complexity molecular-based laboratory developed SARS-CoV-2 assays authorized by this EUA during the COVID-19 public health emergency.  

To see additional authorization documents, such as letters granting EUA amendments or revisions, for a specific test, select the plus (+) button beside the "Date Last Updated" for each test.

All tests in this table are multiple target tests unless noted with an asterisk (*). Multiple target tests are designed to detect two or more viral targets, or sections of the SARS-CoV-2 genome. Tests with an asterisk are single target tests. Single target tests are designed to detect only one viral target on the SARS-CoV-2 genome. Tests with multiple targets are more likely to continue to perform well when new variants emerge. Tests with single targets are more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants.

All authorized devices in the table below are assigned the QJR product code.

Date Last Updated Laboratory Letter Granting Inclusion under EUA and Original Issue Date EUA Summary Other Documents
06/04/2020 Altru Diagnostics, Inc. Altru Dx SARS-CoV-2 RT-PCR assay
04/30/2020
EUA Summary

Letter Granting EUA Amendment(s) (June 4, 2020)

Viral Mutation Revision Letter - September 23, 2021

08/24/2022 Nationwide Children's Hospital SARS-CoV-2 Assay
04/27/2020
EUA Summary Viral Mutation Revision Letter - September 23, 2021
09/22/2020 Diatherix Eurofins Laboratory SARS-CoV-2 PCR Test
04/22/2020
EUA Summary Viral Mutation Revision Letter - September 23, 2021
04/10/2020 Orig3n, Inc. Orig3n 2019 Novel Coronavirus (COVID-19) Test
04/10/2020
EUA Summary Viral Mutation Revision Letter - September 23, 2021
04/10/2020 Specialty Diagnostic (SDI) Laboratories SDI SARS-CoV-2 Assay *
04/10/2020
EUA Summary Viral Mutation Revision Letter - September 23, 2021
04/02/2020 Infectious Disease Diagnostics Laboratory - Children's Hospital of Philadelphia SARS-CoV-2 RT-PCR test *
04/02/2020
EUA Summary Viral Mutation Revision Letter - September 23, 2021
03/07/2023 Yale New Haven Hospital,
Clinical Virology Laboratory
SARS-CoV-2 PCR test
03/31/2020
EUA Summary

Letter Granting EUA Amendment(s) (June 4, 2020)

Viral Mutation Revision Letter - September 23, 2021

Letter Granting EUA Revision(s) (March 07, 2023)

 

03/28/2023 Integrity Laboratories SARS-CoV-2 Assay
04/13/2020
EUA Summary Viral Mutation Revision Letter - September 23, 2021
09/21/2020 Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory CDI Enhanced COVID-19 Test
04/15/2020
EUA Summary Viral Mutation Revision Letter - September 23, 2021
09/21/2020 CirrusDx Laboratories CirrusDx SARS-CoV-2 Assay
04/15/2020
EUA Summary Viral Mutation Revision Letter - September 23, 2021
03/07/2023 Southwest Regional PCR Laboratory LLC. dba MicroGen DX COVID-19 Key
04/23/2020
EUA Summary Viral Mutation Revision Letter - September 23, 2021
04/24/2020 Ultimate Dx Laboratory UDX SARS-CoV-2 Molecular Assay *
04/24/2020
EUA Summary Viral Mutation Revision Letter - September 23, 2021
01/28/2021 AIT Laboratories SARS-CoV-2 Assay
04/24/2020
EUA Summary Viral Mutation Revision Letter - September 23, 2021
03/22/2023 UTMG Pathology Laboratory UTHSC/UCH SARS-CoV-2-RT-PCR Assay
05/03/2020
EUA Summary

Letter Granting EUA Amendment(s) (July 22, 2020)

Viral Mutation Revision Letter - September 23, 2021

Letter Granting EUA Revision(s) - March 22, 2023

12/28/2020 Biocollections Worldwide, Inc. Biocollections Worldwide SARS-Co-V-2 Assay
05/07/2020
EUA Summary Viral Mutation Revision Letter - September 23, 2021
09/14/2020 Columbia University Laboratory of Personalized Genomic Medicine TRIPLEX CII-SARS-CoV-2 rRT-PCR TEST
05/12/2020
EUA Summary

Letter Granting EUA Revision(s) (September 14, 2020)

Viral Mutation Revision Letter - September 23, 2021

05/13/2020 One Health Laboratories, LLC SARS-CoV-2 Real-Time RT-PCR-Test
05/13/2020
EUA Summary Viral Mutation Revision Letter - September 23, 2021
01/29/2021 CSI Laboratories CSI SARS-CoV-2 RT PCR Test
06/01/2020
EUA Summary Viral Mutation Revision Letter - September 23, 2021
05/22/2020 Avera Institute for Human Genetics Avera Institute for Human Genetics SARS-CoV-2 Assay
05/22/2020
EUA Summary Viral Mutation Revision Letter - September 23, 2021
06/10/2020 Warrior Diagnostics, Inc. Warrior Diagnostics SARS-CoV-2 Assay
06/10/2020
EUA Summary Viral Mutation Revision Letter - September 23, 2021
05/03/2022 Cormeum Laboratory Services Cormeum SARS-CoV-2 Assay
06/12/2020
EUA Summary

Viral Mutation Revision Letter - September 23, 2021

Letter Granting EUA Revision(s) (May 3, 2022)

1 The tests listed in this table are all molecular-based tests for COVID-19 and the authorized setting is for use in the identified laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

 
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