Overview of Current COVID-19 Diagnostic Devices with FDA Emergency Use Authorization
As of May 13, 2023, there are 430 in vitro diagnostic EUAs (279 molecular/collection, 62 antigen, 1 breath test, 83 serology, 4 COVID-19 management IVD), 10 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 |
---|---|---|---|---|---|
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, M | HCP 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) |
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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) |
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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 |
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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 | H | HCP Patients IFU |
04/06/2020 | Gnomegen LLC | Gnomegen COVID-19 RT-Digital PCR Detection Kit | Real-time RT-digital PCR | H | HCP 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 | H | HCP 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 | H | HCP Patients IFU |
04/03/2020 | Luminex Corporation | ARIES SARS-CoV-2 Assay | RT-PCR | H, M | HCPPatients 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, M | HCP Patients IFU |
04/01/2020 | Ipsum Diagnostics, LLC | COV-19 IDx Assay | Real-time RT-PCR | H | HCPPatients 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, M | HCPPatients IFU |
03/30/2020 | NeuMoDx Molecular, Inc. | NeuMoDx SARS-CoV-2 Assay | RT-PCR | H, M | HCP 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, W | HCPPatients IFU Letter Granting EUA Amendment(s) (April 21, 2020) |
03/27/2020 | Luminex Molecular Diagnostics, Inc. | NxTAG CoV Extended Panel Assay | RT-PCR | H | HCPPatients IFU |
03/26/2020 | BGI Genomics Co. Ltd. | Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV | Real-time RT-PCR | H | HCPPatients IFU Letter Granting EUA Amendment(s) (April 24, 2020) |
03/25/2020 | Avellino Lab USA, Inc. | AvellinoCoV2 Test | Real-time RT-PCR | H | HCPPatients EUA Summary |
03/24/2020 | PerkinElmer, Inc. | PerkinElmer New Coronavirus Nucleic Acid Detection Kit | Real-time RT-PCR | H | HCPPatients 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, W | HCPPatients IFU Letter Granting EUA Amendment(s) (April 30, 2020) |
03/23/2020 | BioFire Defense, LLC | BioFire COVID-19 Test | RT, Nested multiplex PCR | H, M | HCP 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, W | HCPPatients 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 | H | HCP 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, M | HCP Patients IFU |
03/19/2020 | DiaSorin Molecular LLC | Simplexa COVID-19 Direct Assay | Real-time RT-PCR | H, M | HCP 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 | H | HCP 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 | H | HCP 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 | H | HCP 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 | H | HCP 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, M | HCP 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 | H | HCP 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.
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 (12):
- Baebies Inc., FINDER SARS-CoV-2 Test (used with FINDER 1.5 instrument)
- Biocartis NV, Idylla™ SARS-CoV-2 Test
- Biotrack BV, Escher BT-MED® COV19 Test
- Chai Inc., COVID-19 Saliva Dx Test Kit
- Delphine Diagnostics Inc., Delphine PrecisQT™ COVID-19 Test Kit
- ELITechGroup MDx LLC SARS-CoV-2 ELITe MGB Assay
- Genetic Signatures Limited, EasyScreen™ SARS-CoV-2 Detection Kit RP012
- LG CHEM Ltd., AdvanSure™ One-Stop COVID-19 Kit
- 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