Overview of Current COVID-19 Diagnostic Devices with FDA Emergency Use Authorization

As of August 26, 2023, there are 425 in vitro diagnostic EUAs (275 molecular/collection, 63 antigen, 1 breath test, 83 serology, 3 COVID-19 management IVD), 3 commercial manufacturers that have notified the FDA that they have validated and intend to distribute diagnostic test kits, and no manufacturers that have notified FDA that they have validated and intend to distribute serology tests. 

Please bookmark this page as I will continually update this information as additional EUA's are issued and new commercial diagnostic and serology kits are validated. All information provided in this blog are obtained from FDA's In Vitro Diagnostic EUA and FAQs on Testing for SARS-CoV-2 pages. 

In vitro diagnostic (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. There are several types of SARS-CoV-2 and COVID-19 related IVDs:

Diagnostic Tests - Tests that detect parts of the SARS-CoV-2 virus and can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests and antigen tests.

Serology/Antibody and Other Adaptive Immune Response Tests - Tests that detect antibodies (for example, IgM, IgG) to the SARS-CoV-2 virus or that measure a different adaptive immune response (such as, T cell immune response) to the SARS-CoV-2 virus. These types of tests cannot be used to diagnose a current infection.

Tests for Management of COVID-19 Patients - Beyond tests that diagnose or detect SARS-CoV-2 virus or antibodies, there are also tests that are authorized for use in the management of patients with COVID-19, such as to detect biomarkers related to inflammation. Once patients are diagnosed with COVID-19 disease, these additional tests can be used to inform patient management decisions.

 Numerous COVID-19 in-vitro diagnostic devices have been submitted to FDA for Emergency Use Authorizations (EUA). The following table provides an up-to-date summary of all FDA EUA's. NOTE: the table should be viewed in landscape mode on smaller handheld devices.

There are also a number of SARS-CoV-2 diagnostic and serology tests that are in development or that have been distributed while manufacturers prepare an EUA submission for a test whose performance characteristics have already been validated. Laboratories are also offering serology tests. Current lists of diagnostic and serology tests that fit into these categories are provided after the EUA table.

For more information on serology test performance, including sensitivity (true positive rate) and specificity (true negative rate), visit FDA's EUA Authorized Serology Test Performance page.

Date of EUA Original Issue Entity Letter of Authorization Attributes3 Authorized Settings1 Authorization Documents2
07/20/2023 Alphadera Labs, LLC ALPHADx SARS-COV-2 RT-PCR Test Real-time RT-PCR, Multiple Target(s) H HCP
Patients
EUA Summary
07/17/2023 Immunostics Inc. Swab-N-Go Home Test COVID-19 Ag Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP
IFU
IFU (Home Test)
06/30/2023 Discover Labs Discover Labs COVID-19 Assay Real-time RT-PCR, Multiple Targets H HCP
Patients
EUA Summary
06/08/2023 Michigan State University laboratories, Department of Medicine Olin Student Health Center In-Dx SARS-CoV-2 RT-LAMP Assay RT-LAMP, Single Target H HCP
Patients
EUA Summary
06/05/2023 Acutis Diagnostics SARS-CoV-2 Acutis Multiplex Assay Real-time RT-PCR, Multiple Targets H HCP
Patients
EUA Summary
05/22/2023 BioTeke USA, LLC Bio-Self COVID-19 Antigen Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP
IFU
IFU (Home Test)
05/12/2023 Nano-Ditech Corporation Nano-Check COVID-19 Antigen At-Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP
IFU
IFU (Home Test)
05/03/2023 Access Medical Laboratories, Inc. Global Direct RT-PCR Test Real-time RT-PCR, Single Target H HCP
Patients
EUA Summary
04/26/2023 University of Massachusetts ICTC SARS-CoV-2 RT-PCR Assay Real-time RT-PCR, Multiple Targets H HCP
Patients
EUA Summary
04/24/2023 Princeton BioMeditech Corp. Status COVID-19 Antigen Rapid Test for Home Use Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP
IFU
IFU (Home Test)
04/19/2023 MedArbor, LLC dba MedArbor Diagnostics MedArbor Diagnostics SARS-CoV-2 Assay Real-time RT-PCR, Single Target H HCP
Patients
EUA Summary
04/14/2023 Azure Biotech, Inc. Azure FaStep® COVID-19 Antigen Pen Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP
IFU
IFU (Home Test)
03/24/2023 Biosynchronicity Corporation C-Sync COVID-19 Antigen Test Lateral Flow, Visual Read, Serial Screening, Multiple Targets H, M, W HCP
Patients
IFU
02/24/2023 Lucira Health, Inc. Lucira COVID-19 & Flu Home Test RT, LAMP, Over the Counter (OTC) Home Testing, Multi-analyte, Multiple Targets Home, H, M, W HCP
IFU
IFU (Home Test)
02/22/2023 Mologic, Inc. ASSURE-100 Rapid COVID-19 Test Lateral Flow, Visual Read, Single Target H, M, W HCP
Patients
IFU
02/17/2023 GenBody Inc. GenBody COVID-19 Ag Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home H, M, W HCP
IFU
IFU (Home Test)
02/08/2023 ADL Diagnostics, Inc., dba Anavasi Diagnostics The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector RT-LAMP, Multiple Targets H, M, W HCP
Patients
IFU
02/08/2023 The HFI Laboratory at Boston University (dba the BU Clinical Testing Laboratory) BU SARS-CoV-2 Test Real-time RT-PCR, Multiple Targets H HCP
Patients
EUA Summary
02/03/2023 Becton, Dickinson and Company (BD) BD Respiratory Viral Panel for BD MAX System Real-time RT-PCR, Multi-analyte, Multiple Targets H HCP
Patients
IFU
02/03/2023 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete Assay RT, Non-isothermal Nucleic Acid Amplification qSTAR, Multi-analyte, Single Target H HCP
Patients
IFU
12/23/2022 Visby Medical, Inc. Visby Medical Respiratory Health Test RT-PCR, Multi-analyte, Multiple Targets H, M, W HCP
Patients
IFU
12/22/2022 Oceanit Foundry, LLC ASSURE-100 Rapid COVID-19 Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP
IFU
IFU (Home Test)
12/22/2022 Advin Biotech, Inc. Advin COVID-19 Antigen Test @Home Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP
IFU
IFU (Home Test)
12/20/2022 CTK Biotech, Inc. ImmuView COVID-19 Antigen Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP
IFU
IFU (Home Test)
12/19/2022 OnsiteGene, Inc. Hi-Sense COVID-19 Molecular Testing Kit 1.0 Real-time RT-PCR, Multiple Targets H HCP
Patients
IFU
12/06/2022 ACON Laboratories, Inc. Flowflex COVID-19 Antigen Rapid Test Lateral Flow, Visual Read, Serial Screening, Single Target H, M, W HCP
Patients
IFU
12/06/2022 Diazyme Laboratories, Inc. Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit Total Neutralizing Antibodies, CLIA H, M HCP
Recipients
IFU
11/22/2022 Lucira Health, Inc. Lucira COVID-19 & Flu Test RT-LAMP, Multiple Targets, Multi-analyte H, M, W HCP
Patients
IFU
11/21/2022 CorDX, Inc. CorDx COVID-19 Ag Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP
IFU
IFU (Home Test)
11/21/2022 Azure Biotech, Inc. Fastep COVID-19 Antigen Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP
IFU
IFU (Home Test)
11/18/2022 Premier Medical Laboratory Services Diversified Medical Healthcare SARS-CoV-2 Assay Real-time RT-PCR, Home Collection, Screening, Multiple Targets H HCP
Patients
EUA Summary
IFU (Home Collect)
11/17/2022 Beijing Hotgen Biotech Co., Ltd. Hotgen COVID-19 Antigen Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP
IFU
IFU (Home Test)
11/17/2022 ANP Technologies, Inc. NIDS COVID-19 Antigen Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP
IFU
EUA Summary
IFU (Home Test)
11/08/2022 Nanobiosym Precision Testing Services The Nano Test for COVID-19 Real-time RT-PCR, Home Collection, Saliva, Multiple Targets H HCP
Patients
EUA Summary
IFU
10/18/2022 Aptitude Medical Systems Inc. Metrix COVID-19 Test RT, LAMP, Over the Counter (OTC) Home Testing, Saliva, Screening, Multiple Targets Home, H, M, W HCP
IFU
IFU (Home Test)
07/19/2022 Predicine, Inc. Predicine SARS-CoV-2 RT-PCR Test Real-time RT-PCR, Home Collection, Multiple Targets, Screening, Pooling H HCP
Patients
EUA Summary
IFU (Home Collect)
07/08/2022 Watmind USA Speedy Swab Rapid COVID-19 Antigen Self-Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Single Target Home, H, M, W HCP
IFU
IFU (Home Test)
07/08/2022 Genabio Diagnostics Inc. Genabio COVID-19 Rapid Self-Test Kit Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP
IFU
IFU (Home Test)
06/14/2022 Roche Molecular Systems, Inc. cobas SARS-CoV-2 Duo for use on the cobas 6800/8800 Systems Real-time RT-PCR, Quantitative, Multiple Targets H, M HCP
Patients
IFU
06/01/2022 DxLab Inc. DxLab COVID-19 Test RT-LAMP, Serial Screening, Multiple Targets H, M, W HCP
Patients
IFU
05/31/2022 LG Chem, Ltd. AdvanSure SARS-CoV-2 IgG(RBD) ELISA IgG, ELISA H HCP
Recipients
IFU
05/19/2022 LG Chem, Ltd. AdvanSure SARS-CoV-2 IgG(S1) ELISA IgG, ELISA H HCP
Recipients
IFU
05/17/2022 Laboratory Corporation of America (Labcorp) Labcorp Seasonal Respiratory Virus RT-PCR Test Real-time RT-PCR, Multi-analyte, Home Collection, Single Target H HCP
Patients
EUA Summary
IFU (Home Collect)
05/17/2022 Nexus Medical Labs, LLC Nexus High Throughput SARS-CoV-2 Assay Real-time RT-PCR, Home Collection, Multiple Targets H HCP
Patients
EUA Summary
IFU (Home Collect)
05/16/2022 Laboratory Corporation of America (Labcorp) Labcorp Seasonal Respiratory Virus RT-PCR DTC Test Direct to Consumer (DTC), Real-time RT-PCR, Multi-analyte, Home Collection, Single Target H HCP
Individuals
EUA Summary
IFU (Home Collect)
05/10/2022 Cepheid Xpert Xpress CoV-2 plus Real-time RT-PCR, Multiple Targets H, M, W HCP
Patients
IFU for Labs
IFU for Point-of-Care
05/06/2022 Abbott Diagnostics Scarborough, Inc. ID NOW COVID-19 2.0 RT, Isothermal amplification, Single Target H, M, W HCP
Patients
IFU
04/26/2022 LGC, Biosearch Technologies Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test End-Point RT-PCR, Screening, Multiple Targets H HCP
Patients
IFU
04/26/2022 Audere HealthPulse@home Fusion Home Collection Kit, Screening, Single Target N/A EUA Summary
IFU
04/21/2022 OPTI Medical Systems, Inc. OPTI SARS-CoV-2/ Influenza A/B RT-PCR Test (Version 1 and Version 2) Real-time RT-PCR, Multi-analyte, Multiple Targets H HCP
Patients
IFU
04/14/2022 InspectIR Systems LLC InspectIR COVID-19 Breathalyzer Rapid gas chromatography-mass spectrometry (GC-MS), Five Volatile Organic Compounds (VOCs), Screening Near Patient/Point-of-Care HCP
Patients
IFU
04/14/2022 MicroGEM U.S., Inc. MicroGEM Sal6830 SARS-CoV-2 Saliva Test Real-time RT-PCR, Saliva, Multiple Targets H, M, W HCP
Patients
IFU
04/11/2022 Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute SelfCheck cobas SARS-CoV-2 + Flu Assay Real-time RT-PCR, Home Collection, Multi-analyte, Multiple Targets H HCP
Patients
EUA Summary
IFU (Home Collect)
04/07/2022 UCSD BCG EXCITE Lab UCSD EXCITE COVID-19 EL Test Real-time RT-PCR, Home Collection, Screening, Multiple Targets H HCP
Patients
EUA Summary
IFU (Home Collect)
04/06/2022 DC Department of Health Test Yourself DC At-Home COVID-19 Collection Kit Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening, Multiple Targets H HCP
Individuals
EUA Summary
IFU (Home Collect)
04/06/2022 Xiamen Boson Biotech Co., Ltd. Rapid SARS-CoV-2 Antigen Test Card Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Single Target Home, H, M, W HCP
IFU
IFU (Home Test)
04/06/2022 OSANG LLC OHC COVID-19 Antigen Self Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Single Target Home, H, M, W HCP
IFU
IFU (Home Test)
03/16/2022 PHASE Scientific International, Ltd. INDICAID COVID-19 Rapid Antigen At-Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP
IFU
IFU (Home Test)
03/11/2022 Siemens Healthcare Diagnostics, Inc. Atellica IM SARS-CoV-2 Antigen (CoV2Ag) CLIA, Single Target H, M HCP
Patients
IFU
03/11/2022 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) CLIA, Single Target H, M HCP
Patients
IFU
02/28/2022 Oceanit Foundry LLC ASSURE-100 Rapid COVID-19 Test Lateral Flow, Visual Read, Single Target H, M, W HCP
Patients
IFU
02/08/2022 Uh-Oh Labs Inc. UOL COVID-19 Test RT-LAMP, Single Target H, M, W HCP
Patients
IFU
02/07/2022 Fluidigm Corporation Advanta Dx COVID-19 EASE Assay Real-time RT-PCR, Multiple Targets H HCP
Patients
IFU
01/21/2022 Mammoth Biosciences, Inc. DETECTR BOOST SARS-CoV-2 Reagent Kit RT-LAMP, CRISPR, Single Target H HCP
Patients
IFU
01/19/2022 Maxim Biomedical, Inc. MaximBio ClearDetect COVID-19 Antigen Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP
IFU
IFU (Home Test)
01/14/2022 iHealth Labs, Inc. iHealth COVID-19 Antigen Rapid Test Pro Lateral Flow, Visual Read, Serial Screening, Single Target H, M, W HCP
Patients
IFU
01/07/2022 Premier Medical Laboratory Services PMLS SARS-CoV-2 Assay Real-time RT-PCR, Home Collection, Screening H HCP
Patients
EUA Summary
IFU (Home Collect)
12/29/2021 Siemens Healthineers CLINITEST Rapid COVID-19 Antigen Self-Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening Home, H, M, W HCP
IFU
IFU (Home Collect)
12/24/2021 SD Biosensor, Inc. COVID-19 At-Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening Home, H, M, W HCP
IFU
IFU (Home Collect)
12/17/2021 UCSD BCG EXCITE Lab UCSD EXCITE COVID-19 Test Real-time RT-PCR, Home Collection, Screening H HCP
Patients
EUA Summary
IFU (Home Collect)
12/15/2021 Applied BioCode, Inc. BioCode CoV-2 Flu Plus Assay RT-PCR, Multi-analyte H HCP
Patients
IFU
12/06/2021 Nano-Ditech Corp. Nano-Check COVID-19 Antigen Test Lateral Flow, Visual Read, Serial Screening H, M, W HCP
Patients
IFU
11/30/2021 Audere HealthPulse@home Home Collection Kit, Screening N/A EUA Summary
IFU
11/22/2021 InBios International Inc. SCoV-2 Ag Detect Rapid Self-Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening Home, H, M, W HCP
IFU
IFU (Home Test)
11/09/2021 Meridian Bioscience, Inc. Revogene SARS-CoV-2 Real time RT-PCR H, M HCP
Patients
IFU
11/06/2021 GenScript USA Inc. cPass SARS-CoV-2 Neutralization Antibody Detection Kit Total Neutralizing Antibodies, Blocking ELISA, Semi-quantitative H HCP
Recipients
IFU
11/05/2021 iHealth Labs, Inc. iHealth COVID-19 Antigen Rapid Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening Home, H, M, W HCP
IFU
IFU (Home Test)
11/05/2021 Talis Biomedical Corporation Talis One COVID-19 Test System RT, Isothermal amplification H, M, W HCP
Patients
IFU
10/28/2021 Detect, Inc. Detect Covid-19 Test RT, LAMP, Lateral Flow Strips, Over the Counter (OTC) Home Testing, Serial Screening Home, H, M, W HCP
Individuals
IFU
10/22/2021 InBios International, Inc. SCoV-2 Detect Neutralizing Ab ELISA Total Neutralizing Antibodies, ELISA H HCP
Recipients
IFU
10/21/2021 Celltrion USA, Inc. Celltrion DiaTrust COVID-19 Ag Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening Home, H, M, W HCP
IFU
IFU (Home Test)
10/14/2021 LMSI, LLC (dba Lighthouse Lab Services) CovidNow SARS-CoV-2 Assay Real-time RT-PCR, Home Collection, Screening H HCP
Patients
IFU
IFU (Home Collect)
10/12/2021 Xtrava Health SPERA COVID-19 Ag Test Lateral Flow, Visual Read H, M, W HCP
Patients
IFU
10/08/2021 Quest Diagnostics Infectious Disease, Inc. Quest Diagnostics Collection Kit for COVID-19 Home Collection Kit N/A EUA Summary
IFU
10/06/2021 PerkinElmer, Inc. PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 Real-time RT-PCR, Multi-analyte H HCP
Patients
IFU
10/04/2021 EUROIMMUN US, Inc. EUROIMMUN Anti-SARS-CoV-2 S1 Curve ELISA (IgG) IgG, ELISA, Semi-quantitative H, M HCP
Recipients
IFU
10/04/2021 ACON Laboratories, Inc. Flowflex COVID-19 Antigen Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing Home, H, M, W HCP
IFU
IFU (Home Test)
09/30/2021 Laboratory Corporation of America (Labcorp) Labcorp SARS-CoV-2 & Influenza A/B Assay Real-time RT-PCR, Multi-analyte, Home Collection H HCP
Patients
EUA Summary
IFU (Home Collect)
09/29/2021 Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute SelfCheck cobas SARS-CoV-2 Assay Real-time RT-PCR, Home Collection, Screening H HCP
Patients
EUA Summary
IFU (Home Collect)
09/24/2021 ANP Technologies, Inc. NIDS COVID-19 Antigen Rapid Test Kit Lateral Flow, Visual Read, Serial Screening H, M, W HCP
Patients
IFU
09/22/2021 Life Sciences Testing Center Life Sciences Testing Center COVID-19 Test Real-time RT-PCR, Home Collection H HCP
Patients
EUA Summary
IFU (Home Collect)
09/10/2021 Cepheid Xpert Xpress CoV-2/Flu/RSV plus Real-time RT-PCR, Multi-analyte H, M, W HCP
Patients
IFU for Labs
IFU for Point-of-Care
08/27/2021 Yale School of Public Health, Department of Epidemiology of Microbial Diseases SalivaDirect for use with DTC Kits Direct to Consumer (DTC), Real-time RT-PCR, Saliva, Home Collection, Screening H HCP
Individuals
EUA Summary
08/27/2021 Yale School of Public Health, Department of Epidemiology of Microbial Diseases SalivaDirect DTC Saliva Collection Kit Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening N/A Individual
IFU-1
IFU-2
EUA Summary
08/25/2021 Empire City Laboratories ECL COVID TEST SYSTEM-1 Real-time RT-PCR, Home Collection H HCP
Patients
EUA Summary
IFU (Home Collect)
08/25/2021 Empire City Laboratories ECL COVID TEST SYSTEM Real-time RT-PCR, Home Collection H HCP
Patients
EUA Summary
IFU (Home Collect)
08/25/2021 QIAGEN GmbH QIAreach SARS-CoV-2 Antigen Digital Lateral Flow, Fluore-scence, Instrument Read H, M HCP
Patients
IFU
08/24/2021 InBios International, Inc. SCoV-2 Detect IgG Rapid Test IgG, Lateral Flow, Fingerstick Whole Blood H, M, W HCP
Recipients
IFU
08/24/2021 Becton, Dickinson and Company (BD) BD Veritor At-Home COVID-19 Test Lateral Flow, Digital Read, Over the Counter (OTC) Home Testing, Serial Screening H, M, W HCP
Individuals
IFU
IFU (Home Test)
08/23/2021 The Mount Sinai Hospital, Center for Clinical Laboratories Mount Sinai SARS-CoV-2 Assay Real-time RT-PCR, Home Collection, Saliva, Screening H HCP
Patients
EUA Summary
IFU (Home Collect)
08/13/2021 Kwokman Diagnostics, LLC Kwokman Diagnostics COVID-19 Home Collection Kit Home Collection Kit N/A IFU
EUA Summary
08/11/2021 STS Lab Holdco (a subsidiary of Amazon.com Services LLC) Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test Real-time RT-PCR, Home Collection, Pooling, Screening H HCP
Patients
EUA Summary
IFU (Home Collect)
08/11/2021 STS Lab Holdco (a subsidiary of Amazon.com Services LLC) Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening H HCP
Individuals
EUA Summary
IFU (Home Collect)
FAQ
08/09/2021 Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute SelfCheck COVID-19 TaqPath Multiplex PCR Real-time RT-PCR, Home Collection H HCP
Patients
EUA Summary
IFU (Home Collect)
08/02/2021 Access Bio, Inc. CareStart COVID-19 Antigen Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening Home, H, M, W HCP
Individuals
IFU
IFU (Home Test)
08/02/2021 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 Ab Test Total Antibody, Fluorescence Immunoassay, Fingerstick Whole Blood H, M, W HCP
Recipients
IFU
08/02/2021 Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.) TaqPath COVID-19 MS2 Combo Kit 2.0 Real-time RT-PCR H HCP
Patients
IFU
07/30/2021 Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.) TaqPath COVID-19 Fast PCR Combo Kit 2.0 Real-time RT-PCR, Saliva H HCP
Patients
IFU
07/28/2021 PHASE Scientific International, Ltd. INDICAID COVID-19 Rapid Antigen Test Lateral Flow, Visual Read H, M, W HCP
Patients
IFU
07/22/2021 Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators Total Antibody, CLIA H, M HCP
Recipients
IFU
07/22/2021 Becton, Dickinson and Company BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) Blood Collection Tube Home, H, MHCP and Authorized Laboratories
07/13/2021 GenBody Inc. GenBody COVID-19 Ag Lateral Flow, Visual Read H, M, W HCP
Patients
IFU
07/09/2021 Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator IgG, CLIA, Quantitative H, M HCP
Recipients
IFU
07/08/2021 Ellume Limited ellume.lab COVID Antigen Test Lateral Flow, Fluorescence, Instrument Read H, M, W HCP
Patients
IFU
07/01/2021 Bio-Rad Laboratories BioPlex 2200 SARS-CoV-2 IgG IgG, Bead-based Fluorescent Immunoassay, Semi-quantitative H, M HCP
Recipients
IFU
07/01/2021 Exact Sciences Laboratories COVID-Flu Multiplex Assay Real-time RT-PCR, Multi-analyte, Home Collection H HCP
Patients
 EUA Summary
IFU (Home Collect)
07/08/2021 Thermo Fisher Scientific Inc. TaqPath COVID-19 RNase P Combo Kit 2.0 Real-time RT-PCR, Serial Screening H HCP
Patients
IFU
07/01/2021 Everlywell, Inc. Everlywell COVID-19 & Flu Test Home Collection Kit Home Collection Kit, Multi-analyte N/A IFU
EUA Summary
06/29/2021 BioGX, Inc. BioGX Xfree COVID-19 Direct RT-PCR Real-time RT-PCR H HCP
Patients
IFU
06/17/2021 Siemens Healthcare Diagnostics Inc. ADVIA Centaur SARS-CoV-2 IgG (sCOVG) IgG, CLIA, Semi-quantitative H, M HCP
Recipients
IFU
06/17/2021 WREN Laboratories LLC WREN Laboratories COVID-19 Saliva Test Collection Kit DTC Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening N/A Individuals
EUA Summary
IFU
06/17/2021 WREN Laboratories LLC WREN Laboratories COVID-19 PCR Test DTC Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Saliva Screening H HCP
Individuals
EUA Summary
06/17/2021 Roche Molecular Systems cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) Real-time RT-PCR, Screening H, M, W HCP
Patients
IFU
06/04/2021 Diabetomics, Inc. CovAb SARS-CoV-2 Ab Test Total Antibody, Lateral Flow, Oral Fluid H, M, W HCP
Recipients
IFU
06/04/2021 OraSure Technologies, Inc. InteliSwab COVID-19 Rapid Test Rx Lateral Flow, Visual Read, Prescription Home Testing Home, H, M, W HCP
IFU
IFU (Home Test)
06/04/2021 OraSure Technologies, Inc. InteliSwab COVID-19 Rapid Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening Home, H, M, W HCP
Individuals
IFU
IFU (Home Test)
06/04/2021 OraSure Technologies, Inc. InteliSwab COVID-19 Rapid Test Pro Lateral Flow, Visual Read, Serial Screening H, M, W HCP
Patients
IFU
05/29/2021 Siemens Healthcare Diagnostics Inc. Atellica IM SARS-CoV-2 Total (COV2T) Total Antibody, CLIA H, M HCP
Recipients
IFU
05/28/2021 STS Lab Holdco (a subsidiary of Amazon.com Services LLC) Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening H HCP
Individuals
EUA Summary
IFU
FAQ
05/25/2021 Thermo Fisher Scientific Inc. TaqPath COVID-19 Pooling Kit Real-time RT-PCR, Pooling H HCP
Patients
IFU
05/21/2021 Harvard University Clinical Laboratory (HUCL) Quaeris SARS-CoV-2 Assay Real-time RT-PCR, Home Collection H HCP
Patients
EUA Summary
IFU (Home Collect)
05/20/2021 Salofa Oy Sienna-Clarity COVID-19 Antigen Rapid Test Cassette Lateral Flow, Visual Read H, M, W HCP
Patients
IFU
05/19/2021 DiaSorin, Inc. LIAISON SARS-CoV-2 TrimericS IgG IgG, CLIA, Semi-quantitative H, M HCP
Recipients
IFU
05/17/2021 Phosphorus Diagnostics LLC Phosphorous COVID19 RT-qPCR Test DTC Real-time RT-PCR, Direct to Consumer (DTC), Screening, Salvia H HCP
Individuals
EUA Summary
05/17/2021 Phosphorus Diagnostics LLC Pinpoint by Phosphorus COVID-19 Test Home Collection Kit Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening N/A Individual
EUA Summary
IFU
05/15/2021 Fulgent Therapeutics Fulgent COVID-19 by RT-PCR Test Real-time RT-PCR, Home Collection, Screening H HCP
Patients
EUA Summary
IFU (Home Collect)
05/11/2021 ZEUA Scientific, Inc. ZEUA ELISA SARS-CoV-2 Total Antibody Test System Total Antibody, ELISA H, M HCP
Recipients
IFU
05/11/2021 QIAGEN, GmbH QIAreach Anti-SARS-CoV-2 Total Test Total Antibody, Digital Lateral Flow H, M HCP
Recipients
IFU
05/06/2021 InBios International, Inc. SCoV-2 Ag Detect Rapid Test Lateral Flow, Visual Read, Serial Screening H, M, W HCP
Patients
IFU
04/20/2021 PathogenDx, Inc. DetectX-Rv RT-PCR, DNA Microarray Hybridization H HCP
Patients
IFU
04/19/2021 Inova Diagnostics, Inc. QUANTA Flash SARS-CoV-2 IgG IgG, CLIA, Semi-quantitative H, M HCP
Recipients
IFU
04/19/2021 Southern California Permanente Medical Group Kaiser Permanente High Throughput SARS-CoV-2 Assay Real-Time RT-PCR, Saliva, Home Collection H HCP
Patients
EUA Summary
IFU (Home Collect)
04/16/2021 Synergy Diagnostic Laboratory, Inc., DBA SynergyDx SynergyDx SARS-CoV-2 RNA Test DTC Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening H HCP
Individuals
EUA Summary
IFU (Home Collect)
04/16/2021 Celltrion USA, Inc. Celltrion DiaTrust COVID-19 Ag Rapid Test Lateral Flow, Visual Read, Serial Screening H, M, W HCP
Patients
IFU
04/16/2021 Synergy Diagnostic Laboratory, Inc., DBA SynergyDx SynergyDx SARS-CoV-2 RNA Test Real-time RT-PCR, Home Collection, Screening H HCP
Patients
EUA Summary
IFU (Home Collect)
04/15/2021 LGC, Biosearch Technologies Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test Real-Time and End-Point RT-PCR H HCP
Patients
IFU
04/14/2021 Color Health, Inc. Color SARS-CoV-2 RT-LAMP Diagnostic Assay RT, LAMP, Home Collection, Screening H HCP
Patients
EUA Summary
04/13/2021 Qorvo Biotechnologies, LLC. Omnia SARS-CoV-2 Antigen Test Bulk Acoustic Wave (BAW) Biosensor, Instrument Read H, M HCP
Patients
IFU
04/13/2021 Clinical Enterprise, Inc. Clinical Enterprise SARS-CoV-2 RT-PCR Assay Real-time RT-PCR, Screening H HCP
Patients
EUA Summary
04/13/2021 Clinical Enterprise, Inc. Clinical Enterprise SARS-CoV-2 RT-PCR Assay DTC Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening H HCP
Individuals
EUA Summary
04/12/2021 PerkinElmer Genomics PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit Real-time RT-PCR, Home Collection H HCP
Patients
EUA Summary
04/09/2021 Lucira Health, Inc. Lucira CHECK-IT COVID-19 Test Kit RT, LAMP, Over the Counter (OTC) Home Testing, Screening Home, H, M, W HCP
IFU
IFU (Home Test)
04/09/2021 Thermo Fisher Scientific Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit Real-time RT-PCR H HCP
Patients
IFU
04/09/2021 Yale School of Public Health, Department of Epidemiology of Microbial Diseases SalivaDirect At-Home Collection Kit Home Collection Kit, Saliva, Screening H EUA Summary
IFU
04/05/2021 Symbiotica, Inc. COVID-19 Self-Collected Antibody Test System ELISA, Home Collection, Fingerstick Dried Blood Spot Home, H HCP
Recipients
EUA Summary
IFU (Home Collect)
03/31/2021 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Antigen Self Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening Home, H, M, W HCP
Individuals
IFU
IFU (Home Test)
03/31/2021 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag 2 Card Lateral Flow, Visual Read, Non-prescription Testing, Serial Screening H, M, W HCP
Patients
IFU
03/31/2021 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card 2 Home Test 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)
03/31/2021 Quidel Corporation QuickVue At-Home OTC COVID-19 Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening Home, H, M, W HCP
Individuals
IFU
IFU (Home Test)
03/26/2021 DiaSorin, Inc. LIAISON SARS-CoV-2 Ag CLIA H, M HCP
Patients
IFU
03/25/2021 NeuMoDx Molecular, Inc. NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay Real-time RT-PCR, Multi-analyte H, M HCP
Patients
IFU
03/25/2021 STS Lab Holdco (a subsidiary of Amazon.com Services LLC) Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 Real-time RT-PCR, Home Collection, Screening H HCP
Patients
EUA Summary
03/24/2021 Becton, Dickinson and Company (BD) BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B Chromatographic Digital Immunoassay, Instrument Read, Multi-analyte H, M, W HCP
Patients
IFU
03/23/2021 Twist Bioscience Corporation SARS-CoV-2 NGS Assay Sequencing H HCP
Patients
IFU
03/23/2021 Siemens Healthcare Diagnostics Inc. Atellica IM SARS-CoV-2 IgG (sCOVG) IgG, CLIA, Semi-quantitative H, M HCP
Recipients
IFU
03/22/2021 Beckman Coulter, Inc. Access SARS-CoV-2 IgG II IgG, CLIA, Semi-quantitative H, M HCP
Recipients
IFU
03/19/2021 Color Health, Inc. Color COVID-19 Self-Swab Collection Kit DTC Home Collection Kit, Direct to Consumer (DTC), Screening N/A EUA Summary
Individuals
IFU
03/19/2021 Color Health, Inc. Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC Direct to Consumer (DTC), RT, LAMP, Home Collection, Screening H EUA Summary
Individuals
HCP
03/09/2021 GetMyDNA GetMyDNA COVID-19 Test Home Collection Kit Home Collection Kit, Direct to Consumer (DTC), Screening N/A EUA Summary
Individuals
IFU
03/05/2021 Cue Health Inc. Cue COVID-19 Test for Home and Over The Counter (OTC) Use RT, Isothermal amplification Over the Counter (OTC) Home Testing, Screening Home, H, M, W HCP
Individuals
IFU
IFU (Home Test)
FAQ
03/05/2021 Adaptive Biotechnologies Corporation T-Detect COVID Test T-cell receptor beta (TCR β), Sequencing H HCP
Recipients
EUA Summary
03/05/2021 Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3) Real-time RT-PCR, Home Collection H HCP
Patients
EUA Summary
IFU (Home Collect)
03/04/2021 Abbott Molecular Inc. Alinity m Resp-4-Plex Real-time RT-PCR, Multi-analyte H, M HCP
Patients
IFU
03/03/2021 Luminex Molecular Diagnostics, Inc. NxTAG Respiratory Pathogen Panel + SARS-CoV-2 RT-PCR, Multi-analyte H HCP
Patients
IFU
03/01/2021 Abbott Laboratories Inc. AdviseDx SARS-CoV-2 IgG II IgG, CMIA, Semi-quantitative H, M HCP
Recipients
IFU-ARCHITECT
IFU-Alinityi
03/01/2021 Quidel Corporation QuickVue At-Home COVID-19 Test Lateral Flow, Visual Read, Prescription Home Testing Home, H, W, W HCP
Patients
IFU
IFU (Home Test)
02/26/2021 Viracor Eurofins Clinical Diagnostics Viracor SARS-CoV-2 Assay DTC Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening H HCP
Patients
EUA Summary
02/24/2021 University of Illinois Office of the Vice President for Economic Development and Innovation covidSHIELD Real-time RT-PCR, Saliva H HCP
Patients
EUA Summary
02/13/2021 Gravity Diagnostics, LLC Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC Kits Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening H HCP
Individuals
EUA Summary
02/13/2021 Assurance Scientific Laboratories Assurance SARS-CoV-2 Panel DTC Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening H HCP
Individuals
EUA Summary
IFU (Home Collect)
02/13/2021 Everlywell, Inc. Everlywell COVID-19 Test Home Collection Kit DTC Home Collection Kit, Direct to Consumer (DTC), Screening N/A Individuals
EUA Summary
IFU (Home Collect)
02/11/2021 Bio-Rad Laboratories, Inc. Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit Real-time RT-PCR, Multi-analyte H HCP
Patients
IFU
02/10/2021 Immunodiagnostic Systems Ltd. IDS SARS-CoV-2 IgG IgG, CLIA H, M HCP
Recipients
IFU
02/10/2021 Becton, Dickinson and Company (BD) BD SARS-CoV-2/Flu for BD MAX System Real-time RT-PCR, Multi-analyte H, M HCP
Patients
IFU
02/10/2021 Thermo Fisher Scientific TaqPath COVID-19, FluA, FluB Combo Kit Real-time RT-PCR, Multi-analyte H HCP
Patients
IFU
02/10/2021 Grifols Diagnostic Solutions Inc. Procleix SARS-CoV-2 Assay TMA H HCP
Patients
IFU
02/08/2021 Visby Medical, Inc. Visby Medical COVID-19 Point of Care Test RT-PCR H, M, W HCP
Patients
IFU
IFU (Collect)
02/04/2021 Princeton BioMeditech Corp. Status COVID-19/Flu Lateral Flow, Visual Read, Multi-analyte H, M, W HCP
Patients
IFU
02/04/2021 Clinomics USA Inc. Clinomics TrioDx RT-PCR COVID-19 Test Real-time RT-PCR H HCP
Patients
IFU
01/22/2021 Ambry Genetics Laboratory Ambry COVID-19 RT-PCR Test Real-time RT-PCR, Home Collection, Saliva H HCP
Patients
IFU (Home Collect)
EUA Summary
01/19/2021 Hospital of the University of Pennsylvania BD MAX COVID-19 ASSAY (Authorized by HHS/OASH) Real-time RT-PCR H HCP
Patients
EUA Summary
01/19/2021 INNO Diagnostics Reference Laboratory, Ponce Medical School PMSF-INNO SARS-CoV-2 RT-PCR Test (Authorized by HHS/OASH) Real-time RT-PCR H HCP
Patients
EUA Summary
01/15/2021 United Biomedical, Inc. UBI SARS-CoV-2 ELISA IgG, ELISA H HCP
Recipients
IFU
01/15/2021 Bio-Rad Laboratories, Inc. Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit Real-time RT-PCR H HCP
Patients
IFU
01/14/2021 SML GENETREE Co., Ltd. Ezplex SARS-CoV-2 G Kit Real-time RT-PCR, Pooling H HCP
Patients
IFU
01/11/2021 Phadia AB EliA SARS-CoV-2-Sp1 IgG Test IgG, Fluoro-enzyme Immuno-assay, Semi-quantitative H, M HCP
Recipients
IFU
01/11/2021 ADVAITE, Inc. RapCov Rapid COVID-19 Test IgG, Lateral Flow, Fingerstick Whole Blood H, M, W HCP
Recipients
IFU
01/11/2021 Ortho Clinical Diagnostics, Inc. VITROS Immuno-diagnostic Products SARS-CoV-2 Antigen Reagent Pack Chemilumin-escence Immuno-assay, Instrument Read H, M HCP
Patients
IFU
01/08/2021 Siemens Healthcare Diagnostics Inc. Dimension EXL SARS‑CoV‑2 IgG (CV2G) IgG, CLIA, Semi-quantitative H, M, W HCP
Recipients
IFU
01/08/2021 Siemens Healthcare Diagnostics Inc. Dimension Vista SARS‑CoV‑2 IgG (COV2G) IgG, CLIA, Semi-quantitative H, M, W HCP
Recipients
IFU
01/05/2021 Quanterix Corporation Simoa SARS-CoV-2 N Protein Antigen Test Para-magnetic Microbead-based Immuno-assay H, M HCP
Patients
IFU
12/31/2020 Nirmidas Biotech, Inc. MidaSpot COVID-19 Antibody Combo Detection Kit IgM and IgG, lateral flow H, M, W HCP
Recipients
IFU
12/23/2020 Cepheid Xpert Xpress SARS-CoV-2 DoD Real-time RT-PCR, Pooling H, M, W HCP
Patients
EUA Summary
12/23/2020 Quanterix Corporation Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test IgG, Para-magnetic Microbead-based Sandwich ELISA, Semi-quantitative H, M HCP
Recipients
IFU
12/23/2020 Quidel Corporation Solana SARS-CoV-2 Assay Isothermal Reverse Tran-scriptase – Helicase-Dependent Amplification (RT-HDA) H, M HCP
Patients
IFU
12/18/2020 Quidel Corporation QuickVue SARS Antigen Test Lateral Flow, Visual Read H, M, W HCP
Patients
IFU
12/18/2020 Siemens Healthcare Diagnostics Inc. ADVIA Centaur IL6 Assay One-step Direct Chemilumin-escent Immuno-assay H, M HCP
Patients
IFU
12/17/2020 Materials and Machines Corporation of America (DBA MatmaCorp, Inc.) MatMaCorp COVID-19 2SF Test RT-PCR and isothermal nucleic acid amplification H HCP
Patients
IFU
12/17/2020 Hologic, Inc. Aptima SARS-CoV-2/Flu Assay Real-time TMA, Chemilumin-escent, Multi-analyte H HCP
Patients
IFU
12/16/2020 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card Home Test Lateral Flow, Visual Read, Prescription Home Testing HCP
IFU
IFU (Home Test)
12/15/2020 ACON Laboratories, Inc. ACON SARS-CoV-2 IgG/IgM Rapid Test IgM and IgG, Lateral Flow H, M HCP
Recipients
IFU
12/15/2020 Ellume Limited Ellume COVID-19 Home Test Lateral Flow, Fluore-scence, Instrument Read, Over the Counter HCP
IFU
IFU (Home Test)
12/15/2020 RCA Laboratory Services LLC dba GENETWORx GENETWORx Covid-19 Nasal Swab Test Real-time RT-PCR, Home Collection H HCP
Patients
EUA Summary
IFU (Home Collect)
12/11/2020 ResearchDx, Inc., DBA Pacific Diagnostics PacificDx Covid-19 TMA, Chemilumin-escent, Home Collection H HCP
Patients
EUA Summary
12/09/2020 Laboratory Corporation of America (LabCorp) Pixel by LabCorp COVID-19 Test Home Collection Kit Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening H HCP
Individuals
EUA Summary
IFU (Home Collect)
12/07/2020 Luminostics, Inc. Clip COVID Rapid Antigen Test Lateral flow immuno-luminescent assay, instrument read H, M, W HCP
Patients
IFU
12/04/2020 Quest Diagnostics Infectious Disease, Inc. Quest Diagnostics RC COVID-19+Flu RT-PCR Real-time RT-PCR, Multi-analyte, Home Collection H HCP
Patients
 EUA Summary
IFU (Home Collection)
11/27/2020 Cepheid Xpert Omni SARS-CoV-2 Real-time RT-PCR H, M HCP
Patients
IFU
11/25/2020 Roche Diagnostics, Inc. Elecsys Anti-SARS-CoV-2 S Total Antibody, ECLIA, Semi-quantitative H, M HCP
Recipients
IFU
11/24/2020 Kantaro Biosciences, LLC COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit IgG, ELISA, Semi-quantitative H HCP
Recipients
IFU
11/23/2020 Innovita (Tangshan) Biological Technology Co., Ltd. Innovita 2019-nCoV Ab Test (Colloidal Gold) IgM and IgG, Lateral Flow H, M HCP
Recipients
IFU
11/23/2020 RapidRona, Inc. RapidRona Self-Collection Kit Home Collection Kit N/A EUA Summary
IFU (Collection)
11/23/2020 Gravity Diagnostics, LLC Gravity Diagnostics SARS-CoV-2 RT-PCR Assay Real-time RT-PCR, Home Collection, Screening, Saliva H HCP
Patients
EUA Summary
11/17/2020 Lucira Health, Inc. Lucira COVID-19 All-In-One Test Kit Prescription Home Testing W HCP
IFU
IFU (Home Test)
11/06/2020 GenScript USA Inc. cPass SARS-CoV-2 Neutralization Antibody Detection Kit Total Neutralizing Antibodies, Blocking ELISA H HCP
Recipients
IFU
10/28/2020 Quansys Biosciences, Inc. Q-Plex SARS-CoV-2 Human IgG (4 Plex) IgG, CLIA H HCP
Recipients
IFU
10/28/2020 DNA Genotek Inc. ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100 saliva collection devices Saliva Collection Device N/A EUA Summary
IFU
10/26/2020 Agena Bioscience, Inc. MassARRAY SARS-CoV-2 Panel RT-PCR, chip array and MALDI-TOF Mass Spec. H HCP
Patients
IFU
10/23/2020 Celltrion USA, Inc. Sampinute COVID-19 Antigen MIA Magnetic Force-assisted Electrochemical Sandwich Immunoassay (MESIA) H, M HCP
Patients
IFU
10/20/2020 binx health, Inc. binx health At-Home Nasal Swab COVID-19 Sample Collection Kit Home Collection Kit N/A EUA Summary
IFU
10/15/2020 Clinical Enterprise, Inc. EmpowerDX At-Home COVID-19 PCR Test Kit Home Collection Kit N/A EUA Summary
IFU
10/14/2020 DNA Genotek Inc. OMNIgene·ORAL OM-505 and OME-505 (OMNIgene·ORAL) saliva collection devices Saliva Collection Device N/A EUA Summary
IFU
10/14/2020 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 RNA STAR Complete RT, qSTAR amplification H HCP
Patients
IFU
10/09/2020 Abbott Laboratories Inc. AdviseDx SARS-CoV-2 IgM IgM, CMIA H, M HCP
Recipients
IFU-ARCHITECT
IFU-Alinityi
10/08/2020 Access Bio, Inc. CareStart COVID-19 Antigen Test Lateral Flow, Visual Read H, M, W HCP
Patients
IFU
10/08/2020 Beckman Coulter, Inc. Access SARS-CoV-2 IgM IgM, CLIA H, M HCP
Recipients
IFU
10/08/2020 Spectrum Solutions LLC SDNA-1000 Saliva Collection Device Saliva Collection Device N/A EUA Summary
10/07/2020 GenMark Diagnostics, Inc. ePlex Respiratory Pathogen Panel 2 RT-PCR and electro-chemical detection, Multi-analyte H, M HCP
Patients
IFU
10/06/2020 University of California, Los Angeles (UCLA) UCLA SwabSeq COVID-19 Diagnostic Platform RT-PCR and Sequencing H HCP
Patients
EUA Summary
10/06/2020 ZEUA Scientific, Inc. ZEUA ELISA SARS-CoV-2 IgG Test System IgG, ELISA H, M HCP
Recipients
IFU
10/05/2020 Season Biomaterials, Inc. AQ-TOP COVID-19 Rapid Detection Kit PLUS RT-LAMP H HCP
Patients
IFU
10/02/2020 Quidel Corporation Sofia 2 Flu + SARS Antigen FIA Lateral Flow, Fluore-scence, Instrument Read, Multi-Analyte H, M, W HCP
Patients
IFU
10/02/2020 Thermo Fisher Scientific OmniPATH COVID-19 Total Antibody ELISA Test Total Antibody, ELISA H, M HCP
Recipients
IFU
10/02/2020 BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) RT, Nested multiplex PCR, Multi-Analyte H, M, W HCP
Patients
IFU
10/01/2020 Beckman Coulter, Inc. Access IL-6 One-step immuno-enzymatic ("sandwich") assay, IL-6 H, M HCP
Patients
IFU
10/01/2020 UMass Memorial Medical Center UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel Real-time RT-PCR H HCP
Patients
EUA Summary
10/01/2020 Tempus Labs, Inc. iC SARS-CoV2 Test Real-time RT-PCR H HCP
Patients
EUA Summary
09/30/2020 Aeon Global Health Aeon Global Health SARS-CoV-2 Assay Real-time RT-PCR H HCP
Patients
EUA Summary
09/30/2020 Alimetrix, Inc. Alimetrix SARS-CoV-2 RT-PCR Assay RT-PCR, Microarray Hybridization H HCP
Patients
EUA Summary
09/29/2020 CENTOGENE US, LLC CentoSure SARS-CoV-2 RT-PCR Assay Real-time RT-PCR, Screening H HCP
Patients
EUA Summary
09/29/2020 Akron Children’s Hospital Akron Children’s Hospital SARS-CoV-2 Assay Real-time RT-PCR H HCP
Patients
EUA Summary
09/29/2020 National Jewish Health SARS-CoV-2 MassArray Test RT-PCR and MALDI-TOF Mass Spec. H HCP
Patients
EUA Summary
09/29/2020 DiaSorin, Inc. DiaSorin LIAISON SARS-CoV-2 IgM Assay IgM, Indirect CLIA H, M HCP
Recipients
IFU
09/29/2020 NanoEntek America, Inc. FREND COVID-19 total Ab Total Antibody, FIA H, M HCP
Recipients
IFU
09/29/2020 Nirmidas Biotech, Inc. Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit IgM and IgG, Lateral Flow H, M HCP
Recipients
IFU
09/25/2020 Genetrack Biolabs, Inc. Genetrack SARS-CoV-2 Molecular Assay Real-time RT-PCR H HCP
Patients
EUA Summary
09/25/2020 Quotient Suisse SA MosaiQ COVID-19 Antibody Magazine Total Antibody, photometric immuno-assay H HCP
Recipients
IFU
09/24/2020 Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV Real-time RT-PCR, Multi-analyte H, M, W HCP
Patients
IFU for Labs
IFU for Point-of-Care
09/23/2020 Jiangsu Well Biotech Co., Ltd. Orawell IgM/IgG Rapid Test IgM and IgG, Lateral Flow H, M HCP
Recipients
IFU
09/23/2020 Clear Labs, Inc. Clear Dx SARS-CoV-2 Test RT-PCR and Sequencing H HCP
Patients
IFU
09/22/2020 Quadrant Biosciences Inc. Clarifi COVID-19 Test Kit Real-time RT-PCR, Saliva H HCP
Patients
IFU
09/22/2020 Vela Operations Singapore Pte. Ltd. ViroKey SARS-CoV-2 RT-PCR Test v2.0 Real-time RT-PCR H HCP
Patients
IFU
09/21/2020 KimForest Enterprise Co., Ltd. KimForest SARS-CoV-2 Detection Kit v1 Real-time RT-PCR H HCP
Patients
IFU
09/18/2020 GK Pharmaceuticals Contract Manufacturing Operations GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT Real-time RT-PCR H HCP
Patients
IFU
09/16/2020 Visby Medical, Inc. Visby Medical COVID-19 RT-PCR H, M HCP
Patients
IFU
09/14/2020 Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System Real-time RT-PCR, Multi-analyte H, M, W HCP
Patients
IFU
09/14/2020 Shenzhen New Industries Biomedical Engineering Co., Ltd. MAGLUMI 2019-nCoV IgM/IgG IgM and IgG, CLIA H, M HCP
Recipients
IFU
09/09/2020 BioCheck, Inc. BioCheck SARS-CoV-2 IgM Antibody Test Kit IgM, CLIA H, M HCP
Recipients
IFU
09/09/2020 BioCheck, Inc. BioCheck SARS-CoV-2 IgG Antibody Test Kit IgG, CLIA H, M HCP
Recipients
IFU
09/09/2020 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. Wantai SARS-CoV-2 RT-PCR Kit Real-time RT-PCR H HCP
Patients
IFU
09/08/2020 Verily Life Sciences Verily COVID-19 RT-PCR Test Real-time RT-PCR, Pooling H HCP
Patients
EUA Summary
09/04/2020 BillionToOne, Inc. qSanger-COVID-19 Assay Sequencing H HCP
Patients
IFU
09/03/2020 Sugentech, Inc. SGTi-flex COVID-19 IgG IgG, Lateral Flow H, M HCP
Recipients
IFU
09/03/2020 Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Real-time RT-PCR, Multi-analyte H, M HCP
Patients
IFU
09/02/2020 Real-time RT-PCR Bio-Speedy Direct RT-qPCR SARS-CoV-2 Molecular H HCP
Patients
IFU
09/01/2020 Detectachem Inc. MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit RT-LAMP H HCP
Patients
IFU
09/01/2020 OPTOLANE Technologies, Inc. Kaira 2019-nCoV Detection Kit Real-time RT-PCR H HCP
Patients
IFU
08/31/2020 TBG Biotechnology Corp. TBG SARS-CoV-2 IgG / IgM Rapid Test Kit IgM and IgG, Lateral Flow H, M HCP
Recipients
IFU
08/31/2020 University of Arizona Genetics Core for Clinical Services COVID-19 ELISA pan-Ig Antibody Test Total Antibody, ELISA H HCP
Recipients
EUA Summary
08/31/2020 T2 Biosystems, Inc. T2SARS-CoV-2 Panel RT, amplification, T2 Magnetic resonance H HCP
Patients
IFU
08/31/2020 MiraDx MiraDx SARS-CoV-2 RT-PCR Assay Real-time RT-PCR H HCP
Patients
EUA Summary
08/31/2020 Mammoth Biosciences, Inc. SARS-CoV-2 DETECTR Reagent Kit RT-LAMP, CRISPR H HCP
Patients
IFU
08/31/2020 BayCare Laboratories, LLC BayCare SARS-CoV-2 RT PCR Assay Real-time RT-PCR, Pooling H HCP
Patients
EUA Summary
08/31/2020 Color Health, Inc. Color COVID-19 Self-Swab Collection Kit Home Collection Kit N/A EUA Summary
 IFU
08/28/2020 Patients Choice Laboratories, LLC PCL SARS-CoV-2 Real-Time RT-PCR Assay Real-time RT-PCR H HCP
Patients
EUA Summary
08/28/2020 DxTerity Diagnostics, Inc. DxTerity SARS-CoV-2 RT PCR CE Test Real-time RT-PCR, Home Collection, Screening, Saliva H HCP
Patients
EUA Summary
IFU (Home Collect)
08/26/2020 Cuur Diagnostics Cuur Diagnostics SARS-CoV-2 Molecular Assay Real-time RT-PCR H HCP
Patients
EUA Summary
08/26/2020 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card Antigen Lateral Flow, Visual Read H, M, W HCP
Patients
IFU
08/25/2020 Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test IgM and IgG, Lateral Flow H, M HCP
Recipients
IFU
08/25/2020 Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay Real-time RT-PCR, Saliva H HCP
Patients
IFU
08/25/2020 QDx Pathology Services QDX SARS-CoV-2 Assay Real-time RT-PCR, Home Collection H HCP
Patients
EUA Summary
IFU (Home Collect)
08/21/2020 Guardant Health, Inc. Guardant-19 Sequencing H HCP
Patients
EUA Summary
08/21/2020 DxTerity Diagnostics, Inc. DxTerity SARS-CoV-2 RT-PCR Test Real-time RT-PCR, Saliva H HCP
Patients
EUA Summary
08/21/2020 Texas Department of State Health Services, Laboratory Services Section Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay Real-time RT-PCR H HCP
Patients
EUA Summary
08/18/2020 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 Ag Test Antigen Microfluidic Immuno-fluorescence Assay, Instrument Read H, M, W HCP
Patients
IFU
08/17/2020 BioCheck, Inc. BioCheck SARS-CoV-2 IgG and IgM Combo Test IgM and IgG, CLIA H, M HCP
Recipients
IFU
08/17/2020 Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit IgM, CLIA H, M HCP
Recipients
IFU
08/17/2020 ZhuHai Sinochips Bioscience Co., Ltd. COVID-19 Nucleic Acid RT-PCR Test Kit Real-time RT-PCR H HCP
Patients
IFU
08/15/2020 Yale School of Public Health, Department of Epidemiology of Microbial Diseases SalivaDirect Real-time RT-PCR, Saliva H HCP
Patients
EUA Summary
08/13/2020 Pro-Lab Diagnostics Pro-AmpRT SARS-CoV-2 Test RT, Isothermal amplification H HCP
Patients
EUA Summary
08/11/2020 Biomeme, Inc. Biomeme SARS-CoV-2 Real-Time RT-PCR Test Real-time RT-PCR H HCP
Patients
IFU
08/11/2020 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 RNA STAR RT, non-isothermal nucleic acid amplification qSTAR H HCP
Patients
IFU
08/10/2020 Solaris Diagnostics Solaris Multiplex SARS-CoV-2 Assay Real-time RT-PCR H HCP
Patients
EUA Summary
08/10/2020 Alpha Genomix Laboratories Alpha Genomix TaqPath SARS-CoV-2 Combo Assay Real-time RT-PCR H HCP
Patients
EUA Summary
08/07/2020 George Washington University Public Health Laboratory GWU SARS-CoV-2 RT-PCR Test Real-time RT-PCR H HCP
Patients
EUA Summary
08/06/2020 bioMérieux SA VIDAS SARS-CoV-2 IgM IgM, ELFA H, M HCP
Recipients
IFU
08/06/2020 bioMérieux SA VIDAS SARS-CoV-2 IgG IgG, ELFA H, M HCP
Recipients
IFU
08/06/2020 Helix OpCo LLC (dba Helix) Helix COVID-19 NGS Test Sequencing H HCP
Patients
EUA Summary
08/05/2020 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. WANTAI SARS-CoV-2 Ab ELISA Total Antibody, ELISA H HCP
Recipients
IFU
08/05/2020 Vela Operations Singapore Pte Ltd. ViroKey SARS-CoV-2 RT-PCR Test Real-time RT-PCR H HCP
Patients
IFU
08/03/2020 ISPM Labs, LLC dba Capstone Healthcare Genus SARS-CoV-2 Assay Real-time RT-PCR H HCP
Patients
EUA Summary
08/03/2020 Wren Laboratories LLC Wren Laboratories COVID-19 PCR Test Real-time RT-PCR H HCP
Patients
EUA Summary
08/03/2020 Ethos Laboratories Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay RT-PCR and MALDI-TOF Mass Spec. H HCP
Patients
EUA Summary
IFU (Home Collect)
08/03/2020 Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute Cleveland Clinic SARS-CoV-2 Assay Real-time RT-PCR H HCP
Patients
EUA Summary
08/03/2020 Poplar Healthcare Poplar SARS-CoV-2 TMA Pooling Assay TMA, chemiluminescent, Pooling H HCP
Patients
EUA Summary
07/31/2020 Siemens Healthcare Diagnostics Inc. Atellica IM SARS-CoV-2 IgG (COV2G) IgG, Semi-quantitative H, M HCP
Recipients
IFU
07/31/2020 Siemens Healthcare Diagnostics Inc. ADVIA Centaur SARS-CoV-2 IgG (COV2G) IgG, Semi-quantitative H, M HCP
Recipients
IFU
07/31/2020 Xiamen Zeesan Biotech Co., Ltd. SARS-CoV-2 Test Kit (Real-time PCR) Real-time RT-PCR H HCP
Patients
IFU
07/31/2020 University of California San Diego Health UCSD RC SARS-CoV-2 Assay Real-time RT-PCR, Pooling H HCP
Patients
EUA Summary
07/30/2020 Clinical Reference Laboratory, Inc. CRL Rapid Response Real-time RT-PCR, Home Collection, Saliva H HCP
Patients
EUA Summary
IFU (Home Collect)
07/27/2020 Eli Lilly and Company Lilly SARS-CoV-2 Assay Real-time RT-PCR H HCP
Patients
EUA Summary
07/27/2020 Sandia National Laboratories SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay Real-time RT-PCR H HCP
Patients
EUA Summary
07/24/2020 Xiamen Biotime Biotechnology Co., Ltd. BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test IgM and IgG, Lateral Flow H, M HCP
Recipients
IFU
07/24/2020 Access Bio, Inc. CareStart COVID-19 IgM/IgG IgM and IgG, Lateral Flow H, M HCP
Recipients
IFU
07/24/2020 Jiangsu CoWin Biotech Co., Ltd. Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluore-scence Probing) Real-time RT-PCR H HCP
Patients
IFU
07/23/2020 Helix OpCo LLC (dba Helix) Helix COVID-19 Test Real-time RT-PCR H HCP
Patients
EUA Summary
07/21/2020 DiaCarta, Inc. QuantiVirus SARS-CoV-2 Multiplex Test Kit Real-time RT-PCR H HCP
Patients
IFU
07/17/2020 Megna Health, Inc. Rapid COVID-19 IgM/IgG Combo Test Kit IgM and IgG, Lateral Flow H, M HCP
Recipients
IFU
07/17/2020 Access Genetics, LLC OraRisk COVID-19 RT-PCR Real-time RT-PCR H HCP
Patients
EUA Summary
07/16/2020 Boston Heart Diagnostics Boston Heart COVID-19 RT-PCR Test Real-time RT-PCR H HCP
Patients
EUA Summary
07/16/2020 Luminex Corporation xMAP SARS-CoV-2 Multi-Antigen IgG Assay IgG, FMIA H HCP
Recipients
IFU
07/15/2020 Quest Diagnostics Infectious Disease, Inc. Quest Diagnostics PF SARS-CoV-2 Assay Real-time RT-PCR, Home Collection H HCP
Patients
EUA Summary
IFU (Home Collect)
07/15/2020 Quest Diagnostics Infectious Disease, Inc. Quest Diagnostics RC SARS-CoV-2 Assay Real-time RT-PCR, Home Collection H HCP
Patients
EUA Summary
IFU (Home Collect)
07/15/2020 Quest Diagnostics Infectious Disease, Inc. Quest Diagnostics HA SARS-CoV-2 Assay TMA, chemiluminescent, Home Collection H HCP
Patients
EUA Summary
IFU (Home Collect)
07/13/2020 Salofa Oy Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette IgM and IgG, Lateral Flow H, M HCP
Recipients
IFU
07/13/2020 KogeneBiotech Co., Ltd. PowerChek 2019-nCoV Real-time PCR Kit Real-time RT-PCR H HCP
Patients
IFU
07/13/2020 Trax Management Services Inc. PhoenixDx SARS-CoV-2 Multiplex Real-time RT-PCR H HCP
Patients
IFU
07/13/2020 Compass Laboratory Services, LLC Compass Laboratory Services SARS-CoV2 Assay Real-time RT-PCR, Home Collection H HCP
Patients
EUA Summary
07/10/2020 Boston Medical Center BMC-CReM COVID-19 Test Real-time RT-PCR H HCP
Patients
EUA Summary
07/10/2020 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd WANTAI SARS-CoV-2 Ab Rapid Test Total Antibody, Lateral Flow H, M HCP
Recipients
IFU
07/09/2020 UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin SARS-CoV-2 RNA DETECTR Assay RT-LAMP H HCP
Patients
EUA Summary
07/09/2020 BioSewoom, Inc. Real-Q 2019-nCoV Detection Kit Real-time RT-PCR H HCP
Patients
IFU
07/08/2020 Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit IgG, CLIA H, M HCP
Recipients
IFU
07/08/2020 Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay Real-time RT-PCR H HCP
Patients
EUA Summary
07/07/2020 Enzo Life Sciences, Inc. AMPIPROBE SARS-CoV-2 Test System Real-time RT-PCR H HCP
Patients
IFU
07/07/2020 Access Bio, Inc. CareStart COVID-19 MDx RT-PCR Real-time RT-PCR H HCP
Patients
IFU
07/07/2020 Gene By Gene Gene By Gene SARS-CoV-2 Detection Test Real-time RT-PCR H HCP
Patients
EUA Summary
07/06/2020 Assure Tech. (Hangzhou Co., Ltd) Assure COVID-19 IgG/IgM Rapid Test Device IgM and IgG, Lateral Flow H, M HCP
Recipients
IFU
07/06/2020 Laboratorio Clinico Toledo Laboratorio Clinico Toledo SARS-CoV-2 Assay Real-time RT-PCR H HCP
Patients
EUA Summary
07/02/2020 Becton, Dickinson and Company (BD) BD Veritor System for Rapid Detection of SARS-CoV-2 Antigen Chromato-graphic Digital Immuno-assay, Instrument Read H, M, W HCP
Patients
IFU
07/02/2020 Centers for Disease Control and Prevention (CDC) Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay Real-time RT-PCR, Multi-analyte H HCP
Patients
IFU
07/01/2020 CENTOGENE US, LLC CentoFast-SARS-CoV-2 RT-PCR Assay Real-time RT-PCR H HCP
Patients
EUA Summary
06/30/2020 InBios International, Inc. SCoV-2 Detect IgM ELISA IgM, ELISA H HCP
Recipients
IFU
06/30/2020 Psomagen, Inc. Psoma COVID-19 RT Test Real-time RT-PCR H HCP
Patients
EUA Summary
06/30/2020 TNS Co., Ltd (Bio TNS) COVID-19 RT-PCR Peptide Nucleic Acid (PNA) Kit RT-PCR H HCP
Patients
IFU
06/30/2020 The Kroger Co. Kroger Health COVID-19 Test Home Collection Kit Home Collection Kit IFU
EUA Summary
06/29/2020 LifeHope Labs LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel Real-time RT-PCR H HCP
Patients
EUA Summary
06/29/2020 Acupath Laboratories, Inc. Acupath COVID-19 Real-Time (RT-PCR) Assay Real-time RT-PCR H HCP
Patients
EUA Summary
06/26/2020 Beckman Coulter, Inc. Access SARS-CoV-2 IgG IgG , CLIA H, M HCP
Recipients
IFU
06/26/2020 Inform Diagnostics, Inc. Inform Diagnostics SARS-CoV-2 RT-PCR Assay Real-time RT-PCR H HCP
Patients
EUA Summary
06/25/2020 Diagnostic Solutions Laboratory, LLC DSL COVID-19 Assay Real-time RT-PCR H HCP
Patients
EUA Summary
06/25/2020 PreciGenome LLC FastPlex Triplex SARS-CoV-2 Detection kit (RT-Digital PCR) RT-digital droplet PCR H HCP
Patients
IFU
06/25/2020 PlexBio Co., Ltd. IntelliPlex SARS-CoV-2 Detection Kit RT-PCR H HCP
Patients
IFU
06/24/2020 University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay Real-time RT-PCR H HCP
Patients
EUA Summary
06/23/2020 HealthQuest Esoterics HealthQuest Esoterics TaqPath SARS-CoV-2 Assay Real-time RT-PCR H HCP
Patients
EUA Summary
06/23/2020 University of Alabama at Birmingham Fungal Reference Lab FRL SARS CoV-2 Test Real-time RT-PCR H HCP
Patients
EUA Summary
06/23/2020 Gencurix, Inc. GenePro SARS-CoV-2 Test Real-time RT-PCR H HCP
Patients
IFU
06/23/2020 Babson Diagnostics, Inc. Babson Diagnostics aC19G1 IgG , CLIA H HCP
Recipients
EUA Summary
06/19/2020 Hangzhou Laihe Biotech Co., Ltd. LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) IgM and IgG Lateral Flow H, M HCP
Recipients
IFU
06/18/2020 Biohit Healthcare (Hefei) Co. Ltd. Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit IgM and IgG Lateral Flow H, M HCP
Recipients
IFU
06/18/2020 Jiangsu Bioperfectus Technologies Co., Ltd. COVID-19 Coronavirus Real Time PCR Kit Real-time RT-PCR H HCP
Patients
IFU
06/18/2020 3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd. TRUPCR SARS-CoV-2 Kit Real-time RT-PCR H HCP
Patients
IFU
06/17/2020 The Ohio State University Wexner Medical Center OSUWMC COVID-19 RT-PCR Test Real-time RT-PCR H HCP
Patients
EUA Summary
06/17/2020 Omnipath-ology Solutions Medical Corporation Omni COVID-19 Assay by RT-PCR Real-time RT-PCR H HCP
Patients
EUA Summary
06/15/2020 Applied BioCode, Inc. BioCode SARS-CoV-2 Assay RT-PCR H HCP
Patients
IFU
06/15/2020 Emory Medical Laboratories SARS-CoV-2 RBD IgG Test Serology IgG H HCP
Recipients
EUA Summary
06/13/2020 Kaiser Permanente Mid-Atlantic States KPMAS COVID-19 Test Real-time RT-PCR, Home Collection, Screening H HCP
Patients
EUA Summary
IFU (Home Collect)
06/12/2020 RTA Laboratories Biological Products Pharma-ceutical and Machinery Industry Diagnovital SARS-CoV-2 Real-Time PCR Kit Real-time RT-PCR H HCP
Patients
IFU
06/10/2020 InBios International, Inc. SCoV-2 Detect IgG ELISA Serology IgG H HCP
Recipients
IFU
06/10/2020 Tide Laboratories, LLC DTPM COVID-19 RT-PCR Test Real-time RT-PCR H HCP
Patients
EUA Summary
06/10/2020 TBG Biotechnology Corp. ExProbe SARS-CoV-2 Testing Kit Real-time RT-PCR H HCP
Patients
IFU
06/10/2020 Cue Health Inc. Cue COVID-19 Test RT, Isothermal amplification H, W, M HCP
Patients
IFU
06/09/2020 Illumina, Inc. Illumina COVIDSeq Test Sequencing H HCP
Patients
IFU
06/09/2020 ChromaCode Inc. HDPCR SARS-CoV-2 Assay Real-time RT-PCR H HCP
Patients
IFU
06/08/2020 Siemens Healthcare Diagnostics Inc. Dimension EXL SARS-CoV-2 Total Antibody Assay (CV2T) Total Antibody H, M HCP
Recipients
IFU
06/08/2020 Euroimmun US Inc. EURO RealTime SARS-CoV-2 Real-time RT-PCR H HCP
Patients
IFU
06/05/2020 Genetron Health (Beijing) Co., Ltd. Genetron SARS-CoV-2 RNA Test Real-time RT-PCR H HCP
Patients
IFU
06/04/2020 Vibrant America Clinical Labs Vibrant COVID-19 Ab Assay Serology IgM and IgG H HCP
Recipients
EUA Summary
06/04/2020 Phosphorus Diagnostics LLC Phosphorus COVID-19 RT-qPCR Test Real-time RT-PCR, Home Collection, Saliva H HCP
Patients
EUA Summary
IFU (Home Collect)
IFU (Clinic)
06/04/2020 Hangzhou Biotest Biotech Co., Ltd. RightSign COVID-19 IgG/IgM Rapid Test Cassette Serology IgM and IgG H HCP
Recipients
IFU
06/02/2020 Roche Diagnostics Elecsys IL-6 Immuno-assay IL-6 H, M HCP
Patients
IFU
06/01/2020 Gravity Diagnostics, LLC Gravity Diagnostics COVID-19 Assay Real-time RT-PCR, Home Collection H HCP
Patients
EUA Summary
05/29/2020 Healgen Scientific LLC COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Serology IgM and IgG H, M HCP
Recipients
IFU
05/29/2020 Siemens Healthcare Diagnostics Inc. Atellica IM SARS-CoV-2 Total (COV2T) Total Antibody H, M HCP
Recipients
IFU
05/29/2020 Siemens Healthcare Diagnostics Inc. ADVIA Centaur SARS-CoV-2 Total (COV2T) Total Antibody H, M HCP
Recipients
IFU
05/28/2020 PrivaPath Diagnostics, Inc. LetsGet Checked Coronavirus (COVID-19) Test TMA, chemiluminescent, Home Collection H HCP
Patients
IFU (Home Collect)
EUA Summary
05/22/2020 dba SpectronRx Hymon SARS-CoV-2 Test Kit Real-time RT-PCR H HCP
Patients
IFU
05/22/2020 Exact Sciences Laboratories SARS-CoV-2 (N gene detection) Test Real-time RT-PCR, Home Collection H HCP
Patients
EUA Summary
IFU (Home Collect)
05/21/2020 BioCore Co., Ltd. BioCore 2019-nCoV Real Time PCR Kit Real-time RT-PCR H HCP
Patients
IFU
05/21/2020 SolGent Co., Ltd. DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit Real-time RT-PCR H HCP
Patients
IFU
05/21/2020 Seasun Biomaterials, Inc. AQ-TOP COVID-19 Rapid Detection Kit RT-LAMP H HCP
Patients
IFU
05/21/2020 P23 Labs, LLC. P23 Labs TaqPath SARS-CoV-2 Assay Real-time RT-PCR, Home Collection, Saliva H HCP
Patients
IFU1 (Home Collect)
IFU2 (Home Collect)
EUA Summary
05/18/2020 Quidel Corporation Lyra Direct SARS-CoV-2 Assay Real-time RT-PCR H HCP
Patients
IFU
05/18/2020 Color Genomics, Inc. Color SARS Cov-2 Diagnostic Assay RT, LAMP, Home Collection H HCP
Patients
EUA Summary
IFU (Home Collect)
IFU (On-site Collect)
05/15/2020 Everlywell, Inc. Everlywell COVID-19 Test Home Collection Kit Home Collection Kit N/A HCP
EFU Summary
05/15/2020 Fulgent Therapeutics, LLC Fulgent COVID-19 by RT-PCR Test Real-time RT-PCR, Home Collection H HCP
Patients
EUA Summary
05/15/2020 Assurance Scientific Laboratories Assurance SARS-CoV-2 Panel Real-time RT-PCR, Home Collection H HCP
Patients
EUA Summary
IFU (Home Collect)
05/14/2020 Hologic, Inc. Aptima SARS-CoV-2 assay TMA, chemiluminescent H HCP
Patients
IFU
05/14/2020 GeneMatrix, Inc. NeoPlex COVID-19 Detection Kit Real-time RT-PCR H HCP
Patients
IFU
05/13/2020 Applied DNA Sciences, Inc. Linea COVID-19 Assay Kit Real-time RT-PCR H HCP
Patients
IFU
05/11/2020 1drop Inc. 1copy COVID-19 qPCR Multi Kit Real-time RT-PCR H HCP
Patients
IFU
05/11/2020 Abbott Molecular Inc. Alinity m SARS-CoV-2 assay Real-time RT-PCR H, M HCP
Patients
IFU
05/08/2020 Quidel Corporation Sofia 2 SARS Antigen FIA Antigen Lateral Flow, Fluore-scence, Instrument Read H, M, W HCP
Patients
IFU
05/08/2020 Gnomegen LLC Gnomegen COVID-19-RT-qPCR Detection Kit Real-time RT-PCR H HCP
Patients
IFU
05/07/2020 Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics - Rutgers University Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-Assay Real-time RT-PCR, Home Collection, Saliva H HCP
Patients
IFU (Home Collect)
EUA Summary
05/07/2020 Zymo Research Corporation Quick SARS-CoV-2rRT-PCR Kit Real-time RT-PCR H HCP
Patients
IFU
05/06/2020 OPTI Medical Systems, Inc. OPTI SARS-CoV-2 RT PCR Test Real-time RT-PCR H HCP
Patients
IFU
05/06/2020 Sherlock BioSciences, Inc. Sherlock CRISPR SARS-CoV-2 Kit RT-LAMP, CRISPR H HCP
Patients
IFU
05/06/2020 BioMérieux SA SARS-COV-2 R-GENE Real-time RT-PCR H HCP
Patients
IFU
05/05/2020 Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company) FTD SARS-CoV-2 Real-time RT-PCR H HCP
Patients
IFU
05/04/2020 EUROIMMUN US Inc. Anti-SARS-CoV-2 ELISA (IgG) Serology IgG H HCP
Recipients
IFU
05/04/2020 Sansure BioTech Inc. Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluore-scence Probing) Real-time RT-PCR H HCP
Patients
IFU
05/02/2020 Roche Diagnostics Elecsys Anti-SARS-CoV-2 Serology Antibody H, M HCP
Recipients
IFU
05/01/2020 Bio-Rad Laboratories, Inc. Bio-Rad SARS-CoV-2 ddPCR Test RT-droplet PCR H HCP
Patients
IFU
05/01/2020 BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1 (RP2.1) RT, Nested multiplex PCR, Multi-analyte H, M HCP
Patients
IFU
04/30/2020 Wadsworth Center, New York State Department of Health New York SARS-CoV Microsphere Immunoassay for Antibody Detection Serology Total Antibody H HCP
Recipients
EUA Summary
04/29/2020 LabGenomics Co., Ltd. LabGun COVID-19 RT-PCR Kit Real-time RT-PCR H HCP
Patients
IFU
04/29/2020 Rheonix, Inc. Rheonix COVID-19 MDx Assay RT-PCR H HCP
Patients
IFU
04/29/2020 Bio-Rad Laboratories Platelia SARS-CoV-2 Total Ab assay Serology Total Antibody H HCP
Recipients
IFU
04/27/2020 Seasun Biomaterials U-TOP COVID-19 Detection Kit Real-time RT-PCR H HCP
Patients
IFU
04/26/2020 Abbott Laboratories Inc. SARS-CoV-2 IgG Assay Serology IgG only H, M HCP
Recipients
IFU-ARCHITECT
IFU-Alinity i
Letter Granting EUA Amendment(s) (May 9, 2020)
04/24/2020 DiaSorin Inc. LIAISON SARS-CoV-2 S1/S2 IgG Serology IgG only H, M HCP
Recipients
IFU
04/24/2020 Ortho-Clinical Diagnostics, Inc. VITROS Immuno-diagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack Serology IgG only H, M HCP
Recipients
IFU
04/24/2020 Autobio Diagnostics Co. Ltd. Anti-SARS-CoV-2 Rapid Test Serology IgM and IgG H, M HCP
Recipients
IFU
04/23/2020 SD Biosensor, Inc. STANDARD M nCoV Real-Time Detection Kit Real-time RT-PCR H HCP
Patients
IFU
04/22/2020 altona Diagnostics GmbH RealStar SARS-CoV02 RT-PCR Kits U.S. Real-time RT-PCR H HCP
Patients
IFU
04/21/2020 Seegene, Inc. Allplex 2019-nCoV Assay Real-time RT-PCR H HCP
Patients
IFU
04/20/2020 Trax Management Services Inc. PhoenixDx 2019-CoV Real-time RT-PCR H HCP
Patients
IFU
Letter Granting EUA Amendments (May 11, 2020)
04/18/2020 OSANG Healthcare GeneFinder COVID-19 Plus RealAmp Kit Real-time RT-PCR H HCP
Patients
IFU
04/17/2020 Fosun Pharma USA Inc. Fosun COVID-19 RT-PCR Detection Kit Real-time RT-PCR H HCP
Patients
IFU
04/16/2020 KorvaLabs Inc. Curative-Korva SARS-Cov-2 Assay Real-time RT-PCR H HCP
Patients
EUA Summary
04/16/2020 GenoSensor, LLC GS™ COVID-19 RT-PCR KIT Real-time RT-PCR H HCP
Patients
IFU
04/15/2020 Maccura Biotechnology (USA) LLC SARS-CoV-2 Fluorescent PCR Kit Real-time RT-PCR H HCP
Patients
IFU
04/15/2020 Mount Sinai Laboratory COVID-19 ELISA IgG Antibody Test Serology IgG H HCP
Patients
EUA Summary
04/14/2020 Ortho Clinical Diagnostics, Inc. VITROS Immuno-diagnostic Products Anti-SARS-CoV-2 Total Reagent Pack Serology Total Antibody H, M HCP
Patients
IFU
Letter Granting EUA Amendment(s) (May 9, 2020)
04/10/2020 Atila BioSystems, Inc. iAMP COVID-19 Detection Kit RT, Isothermal amplification H HCP
Patients
IFU
04/08/2020 DiaCarta, Inc. QuantiVirus SARS-CoV-2 Test Kit H Real-time RT-PCR HCP
Patients
IFU
04/08/2020 Becton, Dickinson & Company BD SARS-CoV-2 Reagents for BD MAX System Real-time RT-PCR H, M HCP
Patients
IFU
04/07/2020 InBios International, Inc. Smart Detect SARS-CoV-2 rRT-PCR Kit Real-time RT-PCR HHCP
Patients
IFU
04/06/2020 Gnomegen LLC Gnomegen COVID-19 RT-Digital PCR Detection Kit Real-time RT-digital PCR HHCP
Patients
IFU
Letter Granting EUA Amendment(s) (April 28, 2020)
04/03/2020 Co-Diagnostics, Inc. Logix Smart Coronavirus Disease 2019 (COVID-19) Kit RT-PCR, CoPrimer technology HHCP
Patients
IFU
04/03/2020 ScienCell Research Laboratories ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit Real-time RT-PCR HHCP
Patients
IFU
04/03/2020 Luminex Corporation ARIES SARS-CoV-2 Assay RT-PCR H, MHCPPatients
IFU
Letter Granting EUA Amendment(s) (May 11, 2020)
04/02/2020 Becton, Dickinson & Company (BD) BioGX SARS-CoV-2 Reagents for BD MAX System Real-time RT-PCR H, MHCP
Patients
IFU
04/01/2020 Ipsum Diagnostics, LLC COV-19 IDx Assay Real-time RT-PCR HHCPPatients
EUA Summary
04/01/2020 Cellex Inc. qSARS-CoV-2 IgG/IgM Rapid Test Serology IgM and IgG H, M HCPPatients
IFU
03/30/2020 QIAGEN GmbH QIAstat-Dx Respiratory SARS-CoV-2 Panel Real-time RT-PCR, Multi-analyte H, MHCPPatients
IFU
03/30/2020 NeuMoDx Molecular, Inc. NeuMoDx SARS-CoV-2 Assay RT-PCR H, MHCP
Patients
IFU
Letter Granting EUA Amendment(s) (April 23, 2020)
03/27/2020 Abbott Diagnostics Scarborough, Inc. ID NOW COVID-19 RT, Isothermal amplification H, M, WHCPPatients
IFU
Letter Granting EUA Amendment(s) (April 21, 2020)
03/27/2020 Luminex Molecular Diagnostics, Inc. NxTAG CoV Extended Panel Assay RT-PCR HHCPPatients
IFU
03/26/2020 BGI Genomics Co. Ltd. Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV Real-time RT-PCR HHCPPatients
IFU
Letter Granting EUA Amendment(s) (April 24, 2020)
03/25/2020 Avellino Lab USA, Inc. AvellinoCoV2 Test Real-time RT-PCR HHCPPatients
EUA Summary
03/24/2020 PerkinElmer, Inc. PerkinElmer New Coronavirus Nucleic Acid Detection Kit Real-time RT-PCR HHCPPatients
IFU
Letter Granting EUA Amendment(s) (April 1, 2020)
03/23/2020 Mesa Biotech Inc. Accula SARS-Cov-2 Test RT and amplification H, M, WHCPPatients
IFU
Letter Granting EUA Amendment(s) (April 30, 2020)
03/23/2020 BioFire Defense, LLC BioFire COVID-19 Test RT, Nested multiplex PCR H, MHCP
Patients
IFU
Letter Granting EUA Amendment(s) (April 30, 2020)
03/20/2020 Cepheid Xpert Xpress SARS-CoV-2 Test Real-time RT-PCR H, M, WHCPPatients
IFU for Labs
IFU for Point-of-Care
Letter Granting EUA Amendment(s) (April 28, 2020)
03/20/2020 Primerdesign Ltd. Primerdesign Ltd COVID-19 genesig Real-Time PCR Assay Real-time RT-PCR HHCP
Patients
IFU
Letter Granting EUA Amendment(s) (April 8, 2020)
03/19/2020 GenMark Diagnostics, Inc. ePlex SARS-CoV-2 Test RT-PCR and electro-chemical detection H, MHCP
Patients
IFU
03/19/2020 DiaSorin Molecular LLC Simplexa COVID-19 Direct Assay Real-time RT-PCR H, MHCP
Patients
IFU
Letter Granting EUA Amendment(s) (March 26, 2020)
Letter Granting EUA Amendment(s) (April 13, 2020)
03/18/2020 Abbott Molecular Abbott RealTime SARS-CoV-2 Assay Real-time RT-PCR HHCP
Patients
IFU
Letter Granting EUA Amendment(s) (April 1, 2020)
03/17/2020 Quest Diagnostics Infectious Disease, Inc. Quest SARS-CoV-2 rRT-PCR Real-time RT-PCR, Home Collection, Pooling HHCP
Patients
IFU
IFU (Home Collect)
03/17/2020 Quidel Corporation Lyra SARS-CoV-2 Assay Real-time RT-PCR H HCP
Patients
IFU
Letter Granting EUA Amendment(s) (April 8, 2020)
03/16/2020 Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test Real-time RT-PCR, Home Collection, Pooling, Screening H HCP
Patients
EUA Summary
IFU (Pixel Home Collect)
IFU (LabCorp Home Collect)
03/16/2020 Hologic, Inc. Panther Fusion SARS-CoV-2 Real-time RT-PCR HHCP
Patients
IFU
Letter Granting EUA Amendment(s) (April 24, 2020)
03/13/2020 Thermo Fisher Scientific, Inc. TaqPath COVID-19 Combo Kit Real-time RT-PCR HHCP
Patients
IFU
Letter Granting EUA Amendment(s) (March 24, 2020)
Letter Granting EUA Amendment(s) (April 20, 2020)
Letter Granting EUA Amendment(s) (May 9, 2020)
03/12/2020 Roche Molecular Systems, Inc. (RMS) cobas SARS-CoV-2 Real-time RT-PCR H, MHCP
Patients
IFU
Letter Granting EUA Amendment(s) (March 31, 2020)
02/29/2020 Wadsworth Center, New York State Department of Public Health's (CDC) New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel Real-time RT-PCR H HCP
Patients
IFU
Letter Granting EUA Amendment(s) (March 15, 2020)
02/04/2020 Centers for Disease Control and Prevention's (CDC) CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) Real-time RT-PCR HHCP
Patients
IFU
Letter Granting EUA Amendment(s) (March 30, 2020)

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;
  • CLIA = chemiluminescence immunoassay;
  • ELISA = enzyme-linked immunosorbent assay;
  • ECLIA = electrochemiluminescence immunoassay;
  • FMIA = fluorescent microsphere immunoassay;
  • CMIA = chemiluminescent microparticle immunoassay;
  • ELFA = enzyme-linked fluorescence assay.

Commercial Manufacturers Distributing Test Kits Under the Policy Outlined in Section IV.C of the Policy for Coronavirus Disease-2019 Tests:

As stated in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution to clinical laboratories of diagnostic test kits to perform assays to detect SARS-CoV-2 for a reasonable period of time after the manufacturer's validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test's performance characteristics on the manufacturer's website. Transparency can help mitigate potential adverse impacts from a poorly designed test by facilitating better informed decisions by potential purchasers and users. As noted in the guidance, the believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high-complexity testing, including testing at the point-of-care when the site is covered by the laboratory's CLIA certificate for high-complexity testing. This policy does not apply to at home testing, including at-home specimen collection.

The commercial manufacturers listed below have notified FDA that they have validated and intend to distribute diagnostic test kits as set forth in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. If this designation is not shown, the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the test, and the test is included in this list to provide transparency regarding the notification submitted to FDA.

Commercial Manufacturer Diagnostic Test Notification List (3):

  • Genetic Signatures Limited, EasyScreen™ SARS-CoV-2 Detection Kit RP012
  • LMSI, LLC d/b/a Lighthouse Lab Services, SalivaNow SARS-CoV-2 Assay Kit
  • Tetracore, Inc., EZ-SARS-CoV-2 Real-Time RT-PCR

Commercial Manufacturers Distributing Test Kits Under the Policy Outlined in Section IV.D of the Policy for Diagnostic Tests for Coronavirus Disease-2019:

As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution of serology tests to identify antibodies to SARS-CoV-2 for a reasonable period of time, where the test has been validated and while the manufacturer is preparing its EUA request, where the manufacturer gives notification to the FDA and information that helps users and patients understand the test results, such as the following, is included in the instructions for use:

  • This test has not been reviewed by the FDA.
  • Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
  • Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

As noted in the guidance, the FDA believes that 10 business days is a reasonable period of time to prepare an EUA submission for such tests. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory's CLIA certificate for high-complexity testing.

This policy does not apply to at-home testing, including at-home specimen collection.

The commercial manufacturers in the list below have notified the FDA that they have validated and intend to distribute a serology test as set forth in Section IV.D of the Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. If this designation is not shown, the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the manufacturer's test, and the test is included in this list to provide transparency regarding the notification submitted to the FDA.
If an EUA request is not submitted within a reasonable period of time, or if significant problems are identified with a test and cannot be or have not been addressed in a timely manner, FDA intends to remove the manufacturer and test from this list, would expect the manufacturer to suspend distribution of the test, and may take additional actions as appropriate. Commercial manufacturers may also voluntarily withdraw their test notification. For these reasons, the number of tests listed below may change (up or down) on a daily basis.

Commercial Manufacturer Serology Test Notification List (0):

  • None at this time