In Vitro Diagnostics EUAs
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 Tests - Tests that detect antibodies (e.g., IgM, IgG) to the SARS-CoV-2 virus. Serology/antibody 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.
Any test developer requesting an EUA that intends to leverage data from another EUA-authorized device must obtain a right of reference to leverage the performance data for that EUA-authorized device. The Centers for Disease Control and Prevention (CDC) has granted a right of reference to the performance data contained in CDC's EUA request (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA:
- Molecular Diagnostic Template for Commercial Manufacturers (updated July 28, 2020)
- Molecular Diagnostic Template for Laboratories (updated July 28, 2020)
- Serology Template for Test Developers (November 24, 2020)
- Antigen Template for Test Developers (October 26, 2020)
- Home Specimen Collection Molecular Diagnostic Template (May 29, 2020)
- Home Specimen Collection Serology Template for Fingerstick Dried Blood Spot (November 24, 2020)
- Template for Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use (July 29, 2020)
These templates are part of the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff, which also includes additional policies specific to this public Health emergency. The templates reflect FDA's current thinking on the data and information that developers should submit to facilitate the EUA process. The templates provide information and recommendations, and we plan to update them as appropriate as we learn more about the COVID-19 disease and gain experience with the EUA process for the various types of COVID-19 tests.
Developers who intend to use alternative approaches should consider seeking the FDA's feedback or recommendations to help them through the EUA process. The FDA encourages developers to discuss any alternative technological approaches to validating their test with the FDA through CDRH-EUA-Templates@fda.hhs.gov.
Members of the public can submit questions about the templates to CDRH-EUA-Templates@fda.hhs.gov, or they can submit comments regarding the templates to the public docket established for the guidance Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff.
Test developers interested in pursuing an EUA may submit a pre-EUA to begin discussions with the FDA or may submit an EUA request to CDRH-EUA-Templates@fda.hhs.gov.
Additional information can be found on the FAQs on Testing for SARS-CoV-2 webpage.
Tables of IVD EUAs:
- Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2
- Umbrella EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests
- Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2
- Individual EUAs for Serology Tests for SARS-CoV-2
- Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2
- Individual EUAs for IVDs for Management of COVID-19 Patients
Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2
This table includes information about authorized SARS-CoV-2 molecular diagnostic tests. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories.
Date EUA Issued or Last Updated | Entity | Diagnostic (Most Recent Letter of Authorization) and Date EUA Original Issue | Attributes3 | Authorized Setting(s)1 | Authorization Documents2 | Other Documents | Other Brand Name(s) |
---|---|---|---|---|---|---|---|
09/01/2020 | SEASUN BIOMATERIALS | U-TOP COVID-19 Detection Kit 04/27/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
04/23/2020 | SD Biosensor, Inc. | STANDARD M nCoV Real-Time Detection Kit 04/23/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
04/22/2020 | altona Diagnostics GmbH | RealStar SARS-CoV02 RT-PCR Kits U.S. 04/22/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
12/01/2020 | Centers for Disease Control and Prevention's (CDC) | CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) 02/04/2020 |
Real-time RT-PCR, Pooling | H | HCP, Patients, IFU | None | |
03/15/2020 | Wadsworth Center, New York State Department of Public Health's (CDC) | New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel 02/29/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
04/24/2020 | BGI Genomics Co. Ltd | Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 03/26/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
01/07/2021 | Cepheid | Xpert Xpress SARS-CoV-2 test 03/20/2020 |
Real-time RT-PCR | H, M, W | HCP, Patients, IFU for Labs, IFU for Point-of-Care |
None | |
01/05/2021 | Primerdesign Ltd. | Primerdesign Ltd COVID-19 genesig Real-Time PCR assay 03/20/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
08/18/2020 | GenMark Diagnostics, Inc. | ePlex SARS-CoV-2 Test 03/19/2020 |
RT-PCR and electrochemical detection | H, M | HCP, Patients, IFU | None | |
06/04/2020 | DiaSorin Molecular LLC | Simplexa COVID-19 Direct assay 03/19/2020 |
Real-time RT-PCR | H, M | HCP, Patients, IFU | None | |
07/30/2020 | Abbott Molecular | Abbott RealTime SARS-CoV-2 assay 03/18/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
11/13/2020 | Quest Diagnostics Infectious Disease, Inc. | Quest SARS-CoV-2 rRT-PCR 03/17/2020 |
Real-time RT-PCR, Home Collection, Pooling | H | HCP, Patients, IFU, IFU (Home Collect) | None | |
04/08/2020 | Quidel Corporation | Lyra SARS-CoV-2 Assay 03/17/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
12/09/2020 | Laboratory Corporation of America (LabCorp) | COVID-19 RT-PCR Test 03/16/2020 |
Real-time RT-PCR, Home Collection, Pooling, Screening | H | HCP, Patients, EUA Summary, IFU LabCorp Home Collect |
None | |
09/23/2020 | Hologic, Inc. | Panther Fusion SARS-CoV-2 Assay 03/16/2020 |
Real-time RT-PCR, Pooling, Screening | H | HCP, Patients, IFU | None | |
12/22/2020 | Thermo Fisher Scientific, Inc. | TaqPath COVID-19 Combo Kit 03/13/2020 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, IFU | None | |
11/18/2020 | Roche Molecular Systems, Inc. (RMS) | cobas SARS-CoV-2 03/12/2020 |
Real-time RT-PCR, Pooling | H, M, H-Pooling | HCP, Patients, IFU | None | |
01/07/2021 | Mesa Biotech Inc. | Accula SARS-Cov-2 Test 03/23/2020 |
RT and amplification | H, M, W | HCP, Patients, IFU | None | |
12/04/2020 | BioFire Defense, LLC | BioFire COVID-19 Test 03/23/2020 |
RT, Nested multiplex PCR, Pooling | H, M | HCP, Patients, IFU | None | |
01/12/2021 | PerkinElmer, Inc. | PerkinElmer New Coronavirus Nucleic Acid Detection Kit 03/24/2020 |
Real-time RT-PCR, Pooling, Screening | H | HCP, Patients, IFU | None | |
09/25/2020 | Avellino Lab USA, Inc. | AvellinoCoV2 test 03/25/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | |
10/28/2020 | Luminex Molecular Diagnostics, Inc. | NxTAG CoV Extended Panel Assay 03/27/2020 |
RT-PCR | H | HCP, Patients, IFU | None | None |
09/17/2020 | Abbott Diagnostics Scarborough, Inc. | ID NOW COVID-19 03/27/2020 |
RT, Isothermal amplification | H, M, W | HCP, Patients, IFU | None | |
09/21/2020 | QIAGEN GmbH | QIAstat-Dx Respiratory SARS-CoV-2 Panel 03/30/2020 |
Real-time RT-PCR, Multi-analyte | H, M | HCP, Patients, IFU | None | None |
04/23/2020 | NeuMoDx Molecular, Inc. | NeuMoDx SARS-CoV-2 Assay 03/30/2020 |
RT-PCR | H, M | HCP, Patients, IFU | None | |
04/01/2020 | Ipsum Diagnostics, LLC | COV-19 IDx assay 04/01/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
09/22/2020 | Becton, Dickinson & Company (BD) | BioGX SARS-CoV-2 Reagents for BD MAX System 04/02/2020 |
Real-time RT-PCR | H, M | HCP, Patients, IFU | None | |
04/03/2020 | Co-Diagnostics, Inc. | Logix Smart Coronavirus Disease 2019 (COVID-19) Kit 04/03/2020 |
RT-PCR, CoPrimer technology | H | HCP, Patients, IFU | None | None |
09/22/2020 | ScienCell Research Laboratories | ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit 04/03/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
10/28/2020 | Luminex Corporation | ARIES SARS-CoV-2 Assay 04/03/2020 |
RT-PCR | H, M | HCP, Patients, IFU | None | |
04/28/2020 | Gnomegen LLC | Gnomegen COVID-19 RT-Digital PCR Detection Kit 04/06/2020 |
Real-time RT-digital PCR | H | HCP, Patients, IFU | None | |
12/28/2020 | InBios International, Inc | Smart Detect SARS-CoV-2 rRT-PCR Kit 04/07/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
10/26/2020 | DiaCarta, Inc | QuantiVirus SARS-CoV-2 Test kit 04/08/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
09/23/2020 | Becton, Dickinson & Company | BD SARS-CoV-2Reagents for BD MAX System 04/08/2020 |
Real-time RT-PCR | H, M | HCP, Patients, IFU | None | |
12/28/2020 | Atila BioSystems, Inc. | iAMP COVID-19 Detection Kit 04/10/2020 |
RT, Isothermal amplification | H | HCP, Patients, IFU | None | |
12/28/2020 | Maccura Biotechnology (USA) LLC | SARS-CoV-2 Fluorescent PCR Kit 04/15/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
06/11/2020 | KorvaLabs Inc. | Curative-Korva SARS-Cov-2 Assay 04/16/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | |
04/16/2020 | GenoSensor, LLC | GS"¢ COVID-19 RT-PCR KIT 04/16/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
12/28/2020 | Fosun Pharma USA Inc. | Fosun COVID-19 RT-PCR Detection Kit 04/17/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
04/18/2020 | OSANG Healthcare | GeneFinder COVID-19 Plus RealAmp Kit 04/18/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
08/08/2020 | Trax Management Services Inc. | PhoenixDx 2019-CoV 04/20/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
11/02/2020 | Seegene, Inc. | Allplex 2019-nCoV Assay 04/21/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
09/22/2020 | LabGenomics Co., Ltd. | LabGun COVID-19 RT-PCR Kit 04/29/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
12/03/2020 | Rheonix, Inc. | Rheonix COVID-19 MDx Assay 04/29/2020 |
RT-PCR, Saliva | H | HCP, Patients, IFU | None | None |
12/09/2020 | Bio-Rad Laboratories, Inc | Bio-Rad SARS-CoV-2 ddPCR Test 05/01/2020 |
RT-droplet PCR | H | HCP, Patients, IFU | None | |
12/22/2020 | BioFire Diagnostics, LLC | BioFire Respiratory Panel 2.1 (RP2.1) 05/01/2020 |
RT, Nested multiplex PCR, Multi-analyte | H, M | HCP, Patients, IFU | None | |
05/04/2020 | Sansure BioTech Inc. | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) 05/04/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
07/09/2020 | Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company) | FTD SARS-CoV-2 05/05/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
01/07/2021 | OPTI Medical Systems, Inc. | OPTI SARS-CoV-2 RT PCR Test 05/06/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
01/14/2021 | Sherlock BioSciences, Inc. | Sherlock CRISPR SARS-CoV-2 Kit 05/06/2020 |
RT-LAMP, CRISPR | H | HCP, Patients, IFU | None | None |
11/06/2020 | BioMérieux SA | SARS-COV-2 R-GENE 05/06/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
11/30/2020 | Infinity BiologiX LLC | Infinity BiologiX TaqPath SARS-CoV-2 Assay 04/10/2020 |
Real-time RT-PCR, Home Collection, Saliva | H |
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12/30/2020 | Zymo Research Corporation | Quick SARS-CoV-2rRT-PCR Kit 05/07/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
05/08/2020 | Gnomegen LLC | Gnomegen COVID-19-RT-qPCR Detection Kit 05/08/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
05/11/2020 | 1drop Inc. | 1copy COVID-19 qPCR Multi Kit 05/11/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
12/23/2020 | Abbott Molecular Inc. | Alinity m SARS-CoV-2 assay 05/11/2020 |
Real-time RT-PCR, Pooling, Screening | H, M | HCP, Patients, IFU | None | |
11/21/2020 | Applied DNA Sciences, Inc. | Linea COVID-19 Assay Kit 05/13/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
10/05/2020 | Hologic, Inc. | Aptima SARS-CoV-2 assay 05/14/2020 |
TMA, chemiluminescent, Pooling, Screening | H | HCP, Patients, IFU | None | |
09/21/2020 | GeneMatrix, Inc. | NeoPlex COVID-19 Detection Kit 05/14/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
06/15/2020 | Fulgent Therapeutics, LLC | Fulgent COVID-19 by RT-PCR Test 05/15/2020 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
09/04/2020 | Everlywell, Inc. | Everlywell COVID-19 Test Home Collection Kit 05/15/2020 |
Home Collection Kit | N/A | IFU, EUA Summary | None | |
09/21/2020 | Assurance Scientific Laboratories | Assurance SARS-CoV-2 Panel 05/15/2020 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
05/18/2020 | Quidel Corporation | Lyra Direct SARS-CoV-2 Assay 05/18/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU |
None |
None |
10/20/2020 | P23 Labs, LLC. | P23 Labs TaqPath SARS-CoV-2 Assay 05/21/2020 |
Real-time RT-PCR, Home Collection, Saliva | H | HCP, Patients, IFU1 (Home Collect), IFU2 (Home Collect) EUA Summary | None | |
05/21/2020 | Seasun Biomaterials, Inc. | AQ-TOP COVID-19 Rapid Detection Kit 05/21/2020 |
RT-LAMP | H | HCP, Patients, IFU | None | None |
12/28/2020 | SolGent Co., Ltd | DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit 05/21/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
12/18/2020 | BioCore Co., Ltd. | BioCore 2019-nCoV Real Time PCR Kit 05/21/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
08/11/2020 | dba SpectronRX | Hymon SARS-CoV-2 Test Kit 05/22/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
10/28/2020 | PrivaPath Diagnostics, Inc. | LetsGetChecked Coronavirus (COVID-19) Test 05/28/2020 |
TMA, chemiluminescent, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
09/21/2020 | Gravity Diagnostics, LLC | Gravity Diagnostics COVID-19 Assay 06/01/2020 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary | None | |
12/28/2020 | Phosphorus Diagnostics LLC | Phosphorus COVID-19 RT-qPCR Test 06/04/2020 |
Real-time RT-PCR, Home Collection, Saliva | H | HCP, Patients, EUA Summary, IFU (Home Collect), IFU (Clinic) |
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06/05/2020 | Genetron Health (Beijing) Co., Ltd. | Genetron SARS-CoV-2 RNA Test 06/05/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
11/04/2020 | Euroimmun US, Inc. | EURORealTime SARS-Cov-2 06/08/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
10/28/2020 | Illumina, Inc. | Illumina COVIDSeq Test 06/09/2020 |
Sequencing | H | HCP, Patients, IFU | None | |
09/21/2020 | ChromaCode Inc. | HDPCR SARS-CoV-2 Assay 06/09/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
06/10/2020 | Tide Laboratories, LLC | DTPM COVID-19 RT-PCR Test 06/10/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
01/06/2021 | TBG Biotechnology Corp. | ExProbe SARS-CoV-2 Testing Kit 06/10/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
08/20/2020 | Cue Health Inc. | Cue COVID-19 Test 06/10/2020 |
RT, Isothermal amplification | H, M, W | HCP, Patients, IFU | None | |
06/12/2020 | RTA Laboratories Biological Products Pharmaceutical and Machinery Industry | Diagnovital SARS-CoV-2 Real-Time PCR Kit 06/12/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
12/07/2020 | Applied BioCode, Inc. | BioCode SARS-CoV-2 Assay 06/15/2020 |
RT-PCR, Pooling | H | HCP, Patients, IFU | None | |
09/09/2020 | Kaiser Permanente Mid-Atlantic States | KPMAS COVID-19 Test 06/13/2020 |
Real-time RT-PCR, Home Collection, Screening | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
12/30/2020 | Jiangsu Bioperfectus Technologies Co., Ltd. | COVID-19 Coronavirus Real Time PCR Kit 06/18/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
06/17/2020 | The Ohio State University Wexner Medical Center | OSUWMC COVID-19 RT-PCR test 06/17/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
12/28/2020 | Omnipathology Solutions Medical Corporation | Omni COVID-19 Assay by RT-PCR 06/17/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
12/17/2020 | 3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd. | TRUPCR SARS-CoV-2 Kit 06/18/2020 |
Real-time RT-PCR, Saliva | H | HCP, Patients, IFU | None | |
09/21/2020 | HealthQuest Esoterics | HealthQuest Esoterics TaqPath SARS-CoV-2 Assay 06/23/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
06/23/2020 | University of Alabama at Birmingham Fungal Reference Lab | FRL SARS CoV-2 Test 06/23/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
12/28/2020 | Gencurix, Inc. | GenePro SARS-CoV-2 Test 06/23/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
06/24/2020 | University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory | MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay 06/24/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
06/25/2020 | Diagnostic Solutions Laboratory, LLC | DSL COVID-19 Assay 06/25/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
06/25/2020 | PreciGenome LLC | FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR) 06/25/2020 |
RT-digital droplet PCR | H | HCP, Patients, IFU | None | None |
06/25/2020 | PlexBio Co., Ltd. | IntelliPlex SARS-CoV-2 Detection Kit 06/25/2020 |
RT-PCR | H | HCP, Patients, IFU | None | None |
06/26/2020 | Inform Diagnostics, Inc. | Inform Diagnostics SARS-CoV-2 RT-PCR Assay 06/26/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
06/29/2020 | LifeHope Labs | LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel 06/29/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
09/24/2020 | Acupath Laboratories, Inc. | Acupath COVID-19 Real-Time (RT-PCR) Assay 06/29/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
09/21/2020 | Psomagen, Inc. | Psoma COVID-19 RT Test 06/30/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
06/30/2020 | TNS Co., Ltd (Bio TNS) | COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit 06/30/2020 |
RT-PCR | H | HCP, Patients, IFU | None | None |
06/30/2020 | The Kroger Co. | Kroger Health COVID-19 Test Home Collection Kit 06/30/2020 |
Home Collection Kit | IFU, EUA Summary | None | None | |
07/01/2020 | CENTOGENE US, LLC | CentoFast-SARS-CoV-2 RT-PCR Assay 07/01/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
01/08/2021 | Centers for Disease Control and Prevention (CDC) | Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay 07/02/2020 |
Real-time RT-PCR, Multi-analyte | H | HCP, Patients, IFU | None | |
12/28/2020 | Laboratorio Clinico Toledo | Laboratorio Clinico Toledo SARS-CoV-2 Assay 07/06/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
12/30/2020 | Enzo Life Sciences, Inc. | AMPIPROBE SARS-CoV-2 Test System 07/07/2020 |
Real-time RT-PCR, Pooling | H | HCP, Patients, IFU | None | None |
07/07/2020 | Access Bio, Inc. | CareStart COVID-19 MDx RT-PCR 07/07/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
12/28/2020 | Gene By Gene | Gene By Gene SARS-CoV-2 Detection Test 07/07/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
12/18/2020 | 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 07/08/2020 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
07/09/2020 | UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin | SARS-CoV-2 RNA DETECTR Assay 07/09/2020 |
RT-LAMP | H | HCP, Patients, EUA Summary | None | None |
12/28/2020 | BioSewoom, Inc. | Real-Q 2019-nCoV Detection Kit 07/09/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
07/10/2020 | Boston Medical Center | BMC-CReM COVID-19 Test 07/10/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
09/21/2020 | KogeneBiotech Co., Ltd. | PowerChek 2019-nCoV Real-time PCR Kit 07/13/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
11/20/2020 | Trax Management Services Inc. | PhoenixDx SARS-CoV-2 Multiplex 07/13/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
07/13/2020 | Compass Laboratory Services, LLC | Compass Laboratory Services SARS-CoV2 Assay 07/13/2020 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary | None | None |
08/21/2020 | Quest Diagnostics Infectious Disease, Inc. | Quest Diagnostics PF SARS-CoV-2 Assay 07/15/2020 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
11/27/2020 | Quest Diagnostics Infectious Disease, Inc. | Quest Diagnostics RC SARS-CoV-2 Assay 07/15/2020 |
Real-time RT-PCR, Home Collection, Pooling | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
08/21/2020 | Quest Diagnostics Infectious Disease, Inc. | Quest Diagnostics HA SARS-CoV-2 Assay 07/15/2020 |
TMA, chemiluminescent, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
09/21/2020 | Boston Heart Diagnostics | Boston Heart COVID-19 RT-PCR Test 07/16/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | |
09/25/2020 | Access Genetics, LLC | OraRisk COVID-19 RT-PCR 07/17/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
12/28/2020 | DiaCarta, Inc. | QuantiVirus SARS-CoV-2 Multiplex Test Kit 07/21/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
10/22/2020 | Helix OpCo LLC | Helix COVID-19 Test 07/23/2020 |
Real-time RT-PCR, Home Collection, Screening | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
07/24/2020 | Jiangsu CoWin Biotech Co., Ltd. | Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 07/24/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
11/02/2020 | Color Genomics, Inc. | Color SARS-CoV-2 RT-LAMP Diagnostic Assay 05/18/2020 |
RT, LAMP, Home Collection | H | HCP, Patients, EUA Summary | None | |
09/21/2020 | Eli Lilly and Company | Lilly SARS-CoV-2 Assay 07/27/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | |
07/27/2020 | Sandia National Laboratories | SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay 07/27/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
07/30/2020 | Clinical Reference Laboratory, Inc. | CRL Rapid Response 07/30/2020 |
Real-time RT-PCR, Home Collection, Saliva | H | None | None | |
11/10/2020 | Xiamen Zeesan Biotech Co., Ltd. | SARS-CoV-2 Test Kit (Real-time PCR) 07/31/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
07/31/2020 | University of California San Diego Health | UCSD RC SARS-CoV-2 Assay 07/31/2020 |
Real-time RT-PCR, Pooling | H | HCP, Patients, EUA Summary | None | None |
10/20/2020 | Wren Laboratories LLC | Wren Laboratories COVID-19 PCR Test 08/03/2020 |
Real-time RT-PCR, Home Collection, Saliva | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
09/21/2020 | Ethos Laboratories | Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay 08/03/2020 |
RT-PCR and MALDI-TOF Mass Spec. | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
08/03/2020 | Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute | Cleveland Clinic SARS-CoV-2 Assay 08/03/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
08/03/2020 | Poplar Healthcare | Poplar SARS-CoV-2 TMA Pooling assay 08/03/2020 |
TMA, chemiluminescent, Pooling | H | HCP, Patients, EUA Summary | None | None |
09/21/2020 | Exact Sciences Laboratories | SARS-CoV-2 (N gene detection) Test 05/22/2020 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect | None | |
08/03/2020 | ISPM Labs, LLC dba Capstone Healthcare | Genus SARS-CoV-2 Assay 08/03/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
08/06/2020 | Helix OpCo LLC (dba Helix) | Helix COVID-19 NGS Test 08/06/2020 |
Sequencing | H | HCP, Patients, EUA Summary | None | None |
08/05/2020 | Vela Operations Singapore Pte Ltd | ViroKey SARS-CoV-2 RT-PCR Test 08/05/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
08/07/2020 | George Washington University Public Health Laboratory | GWU SARS-CoV-2 RT-PCR Test 08/07/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
12/28/2020 | Solaris Diagnostics | Solaris Multiplex SARS-CoV-2 Assay 08/10/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
08/10/2020 | Alpha Genomix Laboratories | Alpha Genomix TaqPath SARS-CoV-2 Combo Assay 08/10/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
12/30/2020 | Biomeme, Inc. | Biomeme SARS-CoV-2 Real-Time RT-PCR Test 08/11/2020 |
Real-time RT-PCR | H | HCP, Patient, IFU | None | None |
12/28/2020 | LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 RNA STAR 08/11/2020 |
RT, non-isothermal nucleic acid amplification qSTAR | H | HCP, Patient, IFU | None | None |
08/13/2020 | Pro-Lab Diagnostics | Pro-AmpRT SARS-CoV-2 Test 08/13/2020 |
RT, Isothermal amplification | H | HCP, Patient, EUA Summary | None | None |
12/16/2020 | Yale School of Public Health, Department of Epidemiology of Microbial Diseases | SalivaDirect 08/15/2020 |
Real-time RT-PCR, Saliva | H | HCP, Patients, EUA Summary | None | |
08/17/2020 | ZhuHai Sinochips Bioscience Co., Ltd. | COVID-19 Nucleic Acid RT-PCR Test Kit 08/17/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
12/28/2020 | Guardant Health, Inc. | Guardant-19 08/21/2020 |
Sequencing | H | HCP, Patients, EUA Summary | None | None |
12/09/2020 | DxTerity Diagnostics, Inc. | DxTerity SARS-CoV-2 RT-PCR Test 08/21/2020 |
Real-time RT-PCR, Saliva | H | HCP, Patients, EUA Summary | None | |
12/28/2020 | Texas Department of State Health Services, Laboratory Services Section | Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay 08/21/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
01/08/2021 | Fluidigm Corporation | Advanta Dx SARS-CoV-2 RT-PCR Assay 08/25/2020 |
Real-time RT-PCR, Saliva | H | HCP, Patients, IFU | None | |
08/25/2020 | QDx Pathology Services | QDX SARS-CoV-2 Assay 08/25/2020 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
10/02/2020 | Cuur Diagnostics | Cuur Diagnostics SARS-CoV-2 Molecular Assay 08/26/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
09/21/2020 | Patients Choice Laboratories, LLC | PCL SARS-CoV-2 Real-Time RT-PCR Assay 08/28/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
08/28/2020 | DxTerity Diagnostics, Inc. | DxTerity SARS-CoV-2 RT PCR CE Test 08/28/2020 |
RT-PCR, Home Collection, Saliva | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
12/28/2020 | T2 Biosystems, Inc. | T2SARS-CoV-2 Panel 08/31/2020 |
RT, amplification, T2 Magnetic resonance | H, M | HCP, Patients, IFU | None | None |
08/31/2020 | MiraDx | MiraDx SARS-CoV-2 RT-PCR assay 08/31/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
08/31/2020 | Mammoth Biosciences, Inc. | SARS-CoV-2 DETECTR Reagent Kit 08/31/2020 |
RT-LAMP, CRISPR | H | HCP, Patients, IFU | None | None |
08/31/2020 | BayCare Laboratories, LLC | BayCare SARS-CoV-2 RT PCR Assay 08/31/2020 |
Real-time RT-PCR, Pooling | H | HCP, Patients, EUA Summary | None | None |
10/06/2020 | Detectachem Inc. | MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit 09/01/2020 |
RT-LAMP | H, M | HCP, Patients, IFU | None | None |
12/28/2020 | OPTOLANE Technologies, Inc. | Kaira 2019-nCoV Detection Kit 09/01/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
09/15/2020 | Color Genomics, Inc. | Color COVID-19 Self-Swab Collection Kit 08/31/2020 |
Home Collection Kit | EUA Summary, IFU | None | None | |
12/09/2020 | Bioeksen R&D Technologies Ltd. | Bio-Speedy Direct RT-qPCR SARS-CoV-2 09/02/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU |
|
|
12/15/2020 | Roche Molecular Systems, Inc. | cobas SARS-CoV-2 & Influenza A/B 09/03/2020 |
Real-time RT-PCR, Multi-analyte | H, M | HCP, Patients, IFU | None | |
09/04/2020 | BillionToOne, Inc. | qSanger-COVID-19 Assay 09/04/2020 |
Sequencing | H | HCP, Patients, IFU | None | None |
12/22/2020 | Verily Life Sciences | Verily COVID-19 RT-PCR Test 09/08/2020 |
Real-time RT-PCR, Pooling, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
10/31/2020 | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | Wantai SARS-CoV-2 RT-PCR Kit 09/09/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
12/10/2020 | Roche Molecular Systems, Inc. | cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System 09/14/2020 |
Real-time RT-PCR, Multi-analyte | H, M, W | HCP, Patients, IFU | None | |
12/28/2020 | Visby Medical, Inc. | Visby Medical COVID-19 09/16/2020 |
RT-PCR | H, M | HCP, Patients, IFU | None | None |
09/18/2020 | GK Pharmaceuticals Contract Manufacturing Operations | GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT 09/18/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
09/21/2020 | KimForest Enterprise Co., Ltd. | KimForest SARS-CoV-2 Detection Kit v1 09/21/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
09/22/2020 | Quadrant Biosciences Inc. | Clarifi COVID-19 Test Kit 09/22/2020 |
Real-time RT-PCR, Saliva | H | HCP, Patients, IFU | None | None |
09/22/2020 | Vela Operations Singapore Pte. Ltd. | ViroKey SARS-CoV-2 RT-PCR Test v2.0 09/22/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
12/28/2020 | Clear Labs, Inc. | Clear Dx SARS-CoV-2 Test 09/23/2020 |
RT-PCR and Sequencing | H | HCP, Patients, IFU | None | None |
09/24/2020 | Cepheid | Xpert Xpress SARS-CoV-2/Flu/RSV 09/24/2020 |
Real-time RT-PCR, Multi-analyte | H, M, W | HCP, Patients, IFU for Labs, IFU for Point-of-Care | None | None |
10/17/2020 | Genetrack Biolabs, Inc. | Genetrack SARS-CoV-2 Molecular Assay 09/25/2020 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
09/30/2020 | Aeon Global Health | Aeon Global Health SARS-CoV-2 Assay 09/30/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
09/29/2020 | CENTOGENE US, LLC | CentoSure SARS-CoV-2 RT-PCR Assay 09/29/2020 |
Real-time RT-PCR, Screening | H | HCP, Patients, EUA Summary | None | None |
09/29/2020 | Akron Children’s Hospital | Akron Children’s Hospital SARS-CoV-2 Assay 09/29/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
09/29/2020 | National Jewish Health | SARS-CoV-2 MassArray Test 09/29/2020 |
RT-PCR and MALDI-TOF Mass Spec. | H | HCP, Patients, EUA Summary | None | None |
09/30/2020 | Alimetrix, Inc. | Alimetrix SARS-CoV-2 RT-PCR Assay 09/30/2020 |
RT-PCR, Microarray Hybridization | H | HCP, Patients, EUA Summary | None | None |
10/01/2020 | Tempus Labs, Inc. | iC SARS-CoV2 Test 10/01/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
12/28/2020 | UMass Memorial Medical Center | UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel 10/01/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
12/22/2020 | BioFire Diagnostics, LLC | BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) 10/02/2020 |
RT, Nested multiplex PCR, Multi-analyte | H, M, W | HCP, Patients, IFU | None | |
10/05/2020 | SEASUN BIOMATERIALS, Inc. | AQ-TOP COVID-19 Rapid Detection Kit PLUS 10/05/2020 |
RT-LAMP | H | HCP, Patients, IFU | None | None |
10/08/2020 | University of California, Los Angeles (UCLA) | UCLA SwabSeq COVID-19 Diagnostic Platform 10/06/2020 |
RT-PCR and Sequencing | H | HCP, Patients, EUA Summary | None | None |
10/07/2020 | GenMark Diagnostics, Inc. | ePlex Respiratory Pathogen Panel 2 10/07/2020 |
RT-PCR and electrochemical detection, Multi-analyte | H, M | HCP, Patients, IFU | None | None |
10/16/2020 | Spectrum Solutions LLC | SDNA-1000 Saliva Collection Device 10/08/2020 |
Saliva Collection Device | N/A | EUA Summary, IFU | None | None |
10/14/2020 | LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 RNA STAR Complete 10/14/2020 |
RT, qSTAR amplification | H | HCP, Patients, IFU | None | None |
12/11/2020 | Clinical Enterprise, Inc. | EmpowerDX At-Home COVID-19 PCR Test Kit 10/15/2020 |
Home Collection Kit | N/A | EUA Summary, IFU | None | None |
12/28/2020 | Viracor Eurofins Clinical Diagnostics | Viracor SARS-CoV-2 assay 04/06/2020 | Real-Time RT-PCR, Home Collection, Pooling | H | HCP, Patients, EUA Summary | None | None |
12/04/2020 | binx health, Inc. | binx health At-Home Nasal Swab COVID-19 Sample Collection Kit 10/20/2020 |
Home Collection Kit | N/A | EUA Summary, IFU | None | None |
11/30/2020 | Agena Bioscience, Inc. | MassARRAY SARS-CoV-2 Panel 10/26/2020 |
RT-PCR, chip array and MALDI-TOF Mass Spec. | H | HCP, Patients, IFU | None | |
10/28/2020 | DNA Genotek Inc. | ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100 saliva collection devices 10/28/2020 |
Saliva Collection Device | N/A | EUA Summary, IFU | None | None |
10/28/2020 | DNA Genotek Inc. | OMNIgene·ORAL OM-505 and OME-505 (OMNIgene·ORAL) saliva collection devices 10/14/2020 |
Saliva Collection Device | N/A | EUA Summary, IFU | None | None |
11/18/2020 | Lucira Health, Inc. | Lucira COVID-19 All-In-One Test Kit 11/17/2020 |
Prescription Home Testing | W | HCP, IFU, IFU (Home Test) | None | None |
11/19/2020 | Express Gene LLC, DBA: Express Gene Molecular Diagnostics Laboratory | Express Gene 2019-nCoV RT-PCR Diagnostic Panel 05/22/2020 |
Real-time RT-PCR, Collection Kit | H | HCP, Patients, EUA Summary, IFU | None | None |
11/23/2020 | RapidRona, Inc. | RapidRona Self-Collection Kit 11/23/2020 |
Home Collection Kit | N/A | EUA Summary, IFU (Collection) | None | None |
12/28/2020 | Gravity Diagnostics, LLC | Gravity Diagnostics SARS-CoV-2 RT-PCR Assay 11/23/2020 |
Real-time RT-PCR, Home Collection, Screening, Saliva | H | HCP, Patients, EUA Summary | None | None |
11/24/2020 | Stanford Health Care Clinical Virology Laboratory | SARS-CoV-2 RT-PCR Assay 04/08/2020 |
Real-time RT-PCR, Home Collection Kit | H | HCP, Patients, EUA Summary, IFU (Home Collection) | None | None |
12/23/2020 | Cepheid | Xpert Omni SARS-CoV-2 11/27/2020 |
Real-time RT-PCR | H, M | HCP, Patients, IFU | None | |
12/04/2020 | Quest Diagnostics Infectious Disease, Inc. | Quest Diagnostics RC COVID-19+Flu RT-PCR 12/04/2020 |
Real-time RT-PCR, Multi-analyte, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collection) | None | None |
12/09/2020 | Laboratory Corporation of America (LabCorp) | Pixel by LabCorp COVID-19 Test Home Collection Kit 12/09/2020 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening | H | HCP, Individuals, EUA Summary, IFU (Home Collect) | None | None |
12/15/2020 | RCA Laboratory Services LLC dba GENETWORx | GENETWORx Covid-19 Nasal Swab Test 12/15/2020 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
12/11/2020 | ResearchDx, Inc., DBA Pacific Diagnostics | PacificDx Covid-19 12/11/2020 |
TMA, chemiluminescent, Home Collection | H | HCP, Patients, EUA Summary | None | None |
12/16/2020 | Hologic, Inc. | Aptima SARS-CoV-2/Flu assay 12/16/2020 |
Real-time TMA, chemiluminescent, Multi-analyte | H | HCP, Patients, IFU | None | None |
12/17/2020 | Materials and Machines Corporation of America (DBA MatmaCorp, Inc.) | MatMaCorp COVID-19 2SF Test 12/17/2020 |
RT-PCR and isothermal nucleic acid amplification | H | HCP, Patients, IFU | None | None |
12/23/2020 | Quidel Corporation | Solana SARS-CoV-2 Assay 12/23/2020 |
Isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA) | H, M | HCP, Patients, IFU | None | None |
12/23/2020 | Cepheid | Xpert Xpress SARS-CoV-2 DoD 12/23/2020 |
Real-time RT-PCR, Pooling | H, M, W | HCP, Patients, EUA Summary | None | None |
01/13/2021 | SML GENETREE Co., Ltd. | Ezplex SARS-CoV-2 G Kit 01/14/2021 |
Real-time RT-PCR, Pooling | H | HCP, Patients, IFU | None | None |
01/15/2021 | Bio-Rad Laboratories, Inc. | Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit 01/15/2021 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
1 Authorized settings include the following:
- H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
- M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
- W - Patient care settings operating under a CLIA Certificate of Waiver.
2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.
- 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;
Umbrella EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests
On March 31, 2020, the FDA issued an umbrella EUA for molecular laboratory developed tests (LDTs) for detection of SARS-CoV-2 that meet certain criteria for eligibility described in the EUA. Under this EUA, authorized tests are authorized for use in the single laboratory that developed the authorized test and that is certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high complexity tests. A manufacturer may request the addition of an eligible molecular-based LDT to Appendix A by submitting a request to CDRH-EUA-Templates@FDA.HHS.GOV.
- EUA Letter of Authorization - Laboratories Who Have Developed a Molecular-Based Test (LDTs) for Coronavirus Disease 2019 (COVID-19)
- Fact Sheet for Healthcare Providers
- Fact Sheet for Patients
- See Appendix A table below for a current list of included laboratories and their LTDs
The table below includes information for the high complexity molecular-based laboratory developed SARS-CoV-2 assays authorized by this Umbrella EUA during the COVID-19 public health emergency.
Appendix A: Authorized Molecular-Based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2
Date EUA Issued or Last Updated | Laboratory | Letter Granting Inclusion under EUA and Original Issue Date | EUA Summary | Other Documents |
---|---|---|---|---|
06/04/2020 | Altru Diagnostics, Inc. | Altru Dx SARS-CoV-2 RT-PCR assay 04/30/2020 |
EUA Summary | Letter Granting EUA Amendment(s) (June 4, 2020) |
04/28/2020 | Biocerna | SARS-CoV-2 Test 04/28/2020 |
EUA Summary | None |
12/28/2020 | Nationwide Children's Hospital | SARS-CoV-2 Assay 04/27/2020 |
EUA Summary | None |
09/22/2020 | Diatherix Eurofins Laboratory | SARS-CoV-2 PCR Test 04/22/2020 |
EUA Summary | None |
04/10/2020 | Orig3n, Inc. | Orig3n 2019 Novel Coronavirus (COVID-19) Test 04/10/2020 |
EUA Summary | None |
04/10/2020 | Specialty Diagnostic (SDI) Laboratories | SDI SARS-CoV-2 Assay 04/10/2020 |
EUA Summary | None |
04/03/2020 | Massachusetts General Hospital | MGH COVID-19 qPCR assay 04/03/2020 |
EUA Summary | None |
04/02/2020 | Diagnostic Molecular Laboratory - Northwestern Medicine | SARS-Cov-2 Assay 04/02/2020 |
EUA Summary | None |
04/02/2020 | Infectious Disease Diagnostics Laboratory - Children's Hospital of Philadelphia | SARS-CoV-2 RT-PCR test 04/02/2020 |
EUA Summary | None |
06/04/2020 | Yale New Haven Hospital, Clinical Virology Laboratory |
SARS-CoV-2 PCR test 03/31/2020 |
EUA Summary | Letter Granting EUA Amendment(s) (June 4, 2020) |
09/21/2020 | University of North Carolina Medical Center | UNC Health SARS-CoV-2 real-time RT-PCR test 04/10/2020 |
EUA Summary | None |
04/13/2020 | Integrity Laboratories | SARS-CoV-2 Assay 04/13/2020 |
EUA Summary | None |
09/21/2020 | Pathology/Laboratory Medicine Lab of Baptist Hospital Miami | COVID-19 RT-PCR Test 04/13/2020 |
EUA Summary | None |
09/21/2020 | Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's Hospital | Childrens-Altona-SARS-CoV-2 Assay 04/14/2020 |
EUA Summary | None |
09/21/2020 | Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory | CDI Enhanced COVID-19 Test 04/15/2020 |
EUA Summary | None |
09/21/2020 | CirrusDx Laboratories | CirrusDx SARS-CoV-2 Assay 04/15/2020 |
EUA Summary | None |
04/14/2020 | Exact Sciences Laboratories | SARS-CoV-2 Test 04/14/2020 |
EUA Summary | None |
07/29/2020 | Mayo Clinic Laboratories, Rochester, MN | SARS-CoV-2 Molecular Detection Assay 04/20/2020 |
EUA Summary | Letter Granting EUA Amendment(s) (July 29, 2020) |
04/23/2020 | Southwest Regional PCR Laboratory LLC. dba MicroGen DX | COVID-19 Key 04/23/2020 |
EUA Summary | None |
04/24/2020 | Ultimate Dx Laboratory | UDX SARS-CoV-2 Molecular Assay 04/24/2020 |
EUA Summary | None |
04/24/2020 | AIT Laboratories | SARS-CoV-2 Assay 04/24/2020 |
EUA Summary | None |
12/28/2020 | UTMG Pathology Laboratory | UTHSC/UCH SARS-CoV-2-RT-PCR Assay 05/03/2020 |
EUA Summary | Letter Granting EUA Amendment(s) (July 22, 2020) |
12/28/2020 | Biocollections Worldwide, Inc. | Biocollections Worldwide SARS-Co-V-2 Assay 05/07/2020 |
EUA Summary | None |
09/14/2020 | Columbia University Laboratory of Personalized Genomic Medicine | TRIPLEX CII-SARS-CoV-2 rRT-PCR TEST 05/12/2020 |
EUA Summary | Letter Granting EUA Revision(s) (September 14, 2020) |
05/13/2020 | One Health Laboratories, LLC | SARS-CoV-2 Real-Time RT-PCR-Test 05/13/2020 |
EUA Summary | None |
05/13/2020 | Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine | SARS-CoV-2-Assay 05/13/2020 |
EUA Summary | None |
06/01/2020 | Aspirus Reference Laboratory | Aspirus SARS-CoV rRT Assay 06/01/2020 |
EUA Summary | None |
06/04/2020 | Nebraska Medicine Clinical Laboratory | NEcov19 RT-PCR Assay 06/04/2020 |
EUA Summary | None |
06/01/2020 | CSI Laboratories | CSI SARS-CoV-2 RT PCR Test 06/01/2020 |
EUA Summary | None |
05/22/2020 | Avera Institute for Human Genetics | Avera Institute for Human Genetics SARS-CoV-2 Assay 05/22/2020 |
EUA Summary | None |
06/10/2020 | Warrior Diagnostics, Inc. | Warrior Diagnostics SARS-CoV-2 Assay 06/10/2020 |
EUA Summary | None |
06/12/2020 | Cormeum Laboratory Services | Cormeum SARS-CoV-2 Assay 06/12/2020 |
EUA Summary | None |
1 The tests listed in this table are all molecular-based tests for COVID-19 and the authorized setting is for use in the identified laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2
This table includes information about authorized SARS-CoV-2 antigen diagnostic tests that have been authorized individually. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories.
Date EUA Issued or Last Updated | Entity | Diagnostic (Most Recent Letter of Authorization) and Date EUA Originally Issued | Attributes | Authorized Setting(s)1 | Authorization Documents2 | Other Documents | Other Brand Name(s) |
---|---|---|---|---|---|---|---|
07/17/2020 | Quidel Corporation | Sofia SARS Antigen FIA 05/08/2020 |
Lateral Flow, Fluorescence, Instrument Read | H, M, W | HCP, Patients, IFU | None | |
01/13/2021 | Becton, Dickinson and Company (BD) | BD Veritor System for Rapid Detection of SARS-CoV-2 07/02/2020 |
Chromatographic Digital Immunoassay, Instrument Read | H, M, W | HCP, Patients, IFU | None | |
08/18/2020 | LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 Ag Test 08/18/2020 |
Microfluidic Immunofluorescence Assay, Instrument Read | H, M, W | HCP, Patients, IFU | None | None |
12/16/2020 | Abbott Diagnostics Scarborough, Inc. | BinaxNOW COVID-19 Ag Card 08/26/2020 |
Lateral Flow, Visual Read | H, M, W | HCP, Patients, IFU | None | None |
10/02/2020 | Quidel Corporation | Sofia 2 Flu + SARS Antigen FIA 10/02/2020 |
Lateral Flow, Fluorescence, Instrument Read, Multi-Analyte | H, M, W | HCP, Patients, IFU | None | None |
10/13/2020 | Access Bio, Inc. | CareStart COVID-19 Antigen test 10/08/2020 |
Lateral Flow, Visual Read | H, M, W | HCP, Patients, IFU | None | None |
10/23/2020 | Celltrion USA, Inc. | Sampinute COVID-19 Antigen MIA 10/23/2020 |
Magnetic Force-assisted Electrochemical Sandwich Immunoassay (MESIA) | H, M | HCP, Patients, IFU | None | None |
12/07/2020 | Luminostics, Inc. | Clip COVID Rapid Antigen Test 12/07/2020 |
Lateral flow immunoluminescent assay, instrument read | H, M, W | HCP, Patients, IFU | None | None |
12/23/2020 | Ellume Limited | Ellume COVID-19 Home Test 12/15/2020 |
Lateral Flow, Fluorescence, Instrument Read, Over the Counter Home Testing | HCP, IFU, IFU (Home Test), FAQ | None | None | |
12/16/2020 | Abbott Diagnostics Scarborough, Inc. | BinaxNOW COVID-19 Ag Card Home Test 12/16/2020 |
Lateral Flow, Visual Read, Prescription Home Testing | HCP, IFU, IFU (Home Test) | None | None | |
12/22/2020 | Quidel Corporation | QuickVue SARS Antigen Test 12/18/2020 |
Lateral Flow, Visual Read | H, M, W | HCP, Patients, IFU | None | None |
01/05/2021 | Quanterix Corporation | Simoa SARS-CoV-2 N Protein Antigen Test 01/05/2021 |
Paramagnetic Microbead-based Immunoassay | H, M | HCP, Patients, IFU | None | None |
01/11/2021 | Ortho Clinical Diagnostics, Inc. | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack 01/11/2021 |
Chemiluminescence Immunoassay, Instrument Read | H, M | HCP, Patients, IFU | None | None |
1 Authorized settings include the following:
- H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
- M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
- W - Patient care settings operating under a CLIA Certificate of Waiver.
2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.
Individual EUAs for Serology Tests for SARS-CoV-2
On August 6, 2020, based on FDA's continued review of the scientific evidence available for Autobio Diagnostics Co. Ltd.'s Anti-SARS-CoV-2 Rapid Test for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood (Heparin/ EDTA/ sodium citrate) or serum 2, including evidence from an NIH/NCI independent evaluation, FDA determined that the statutory criteria for the authorization in Section 564(c)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act are no longer met. Specifically, FDA determined that it is not reasonable to believe the product may be effective in detecting IgM antibodies against SARS-CoV-2 or that the known and potential benefits of the device when used for this purpose outweigh its known and potential risks. FDA also concluded that based on the risks to public health from false test results, revocation is appropriate to protect the public health or safety. Accordingly, the EUA was revoked under Section 564(g)(2)(B) & (C) of the FD&C Act.
On June 16, 2020, based on FDA's continued review of the scientific evidence available for Chembio Diagnostic Systems, Inc.'s DPP COVID-19 IgM/IgG System for detection of IgM and IgG antibodies against SARS-CoV-2, including evidence from an NIH/NCI independent evaluation, FDA determined that the statutory criteria for issuing an EUA in Section 564(c)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act are no longer met. Specifically, FDA determined that it is not reasonable to believe the product may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of the device when used for this purpose outweigh its known and potential risks. FDA also concluded that based on the risks to public health from false test results, revocation is appropriate to protect the public health or safety. Accordingly, the EUA was revoked under Section 564(g)(2)(B) & (C) of the FD&C Act.
This table includes information about authorized SARS-CoV-2 serology/antibody assays that have been authorized individually. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories.
For additional performance information about EUA authorized serology/antibody tests, please see the EUA Authorized Serology Test Performance webpage.
Date EUA Issued or Last Updated | Entity | Diagnostic (Most Recent Letter of Authorization) and Date EUA Originally Issued | Attributes3 | Authorized Setting(s)1 | Authorization Documents2 | Other Documents | Other Brand Name(s) |
---|---|---|---|---|---|---|---|
12/01/2020 | Abbott Laboratories Inc. | SARS-CoV-2 IgG assay 04/26/2020 |
IgG, CMIA | H, M | HCP, Recipients, IFU-ARCHITECT, IFU-Alinityi | None | |
06/12/2020 | Cellex Inc. | qSARS-CoV-2 IgG/IgM Rapid Test 04/01/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Patients, IFU | None | None |
10/30/2020 | Ortho Clinical Diagnostics, Inc. | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack 04/14/2020 |
Total Antibody, CLIA | H, M | HCP, Recipients, IFU | None | |
04/15/2020 | Mount Sinai Laboratory | COVID-19 ELISA IgG Antibody Test 04/15/2020 |
IgG, ELISA | H | HCP, Patients, EUA Summary | None | None |
10/19/2020 | DiaSorin Inc. | LIAISON SARS-CoV-2 S1/S2 IgG 04/24/2020 |
IgG, CLIA | H, M | HCP, Recipients, IFU | None | |
10/23/2020 | Ortho-Clinical Diagnostics, Inc. | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack 04/24/2020 |
IgG, CLIA | H, M | HCP, Recipients, IFU | None | |
10/30/2020 | Bio-Rad Laboratories, Inc. | Platelia SARS-CoV-2 Total Ab assay 04/29/2020 |
Total Antibody, ELISA | H | HCP, Recipients, IFU | None | |
04/30/2020 | Wadsworth Center, New York State Department of Health | New York SARS-CoV Microsphere Immunoassay for Antibody Detection 04/30/2020 |
Total Antibody, FMIA | H | HCP, Recipients, EUA Summary | None | None |
10/23/2020 | Roche Diagnostics | Elecsys Anti-SARS-CoV-2 05/02/2020 |
Total Antibody, ECLIA | H, M | HCP, Recipients, IFU | None | |
05/04/2020 | EUROIMMUN US Inc. | Anti-SARS-CoV-2 ELISA (IgG) 05/04/2020 |
IgG, ELISA | H | HCP, Recipients, IFU | None | None |
05/29/2020 | Healgen Scientific LLC | COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) 05/29/2020 |
IgM and IgG Lateral Flow | H, M | HCP, Recipients, IFU | None | None |
05/29/2020 | Siemens Healthcare Diagnostics Inc. | Atellica IM SARS-CoV-2 Total (COV2T) 05/29/2020 |
Total Antibody, CLIA | H, M | HCP, Recipients, IFU | None | None |
05/29/2020 | Siemens Healthcare Diagnostics Inc. | ADVIA Centaur SARS-CoV-2 Total (COV2T) 05/29/2020 |
Total Antibody, CLIA | H, M | HCP, Recipients, IFU | None | None |
06/04/2020 | Vibrant America Clinical Labs | Vibrant COVID-19 Ab Assay 06/04/2020 |
IgM and IgG, CLIA | H | HCP, Recipients, EUA Summary | None | None |
12/21/2020 | Hangzhou Biotest Biotech Co., Ltd. | RightSign COVID-19 IgG/IgM Rapid Test Cassette 06/04/2020 |
IgM and IgG Lateral Flow, Fingerstick Whole Blood | H, M, W | HCP, Recipients, IFU |
|
|
10/30/2020 | Siemens Healthcare Diagnostics Inc. | Dimension Vista SARS-CoV-2 Total antibody assay (COV2T) 06/08/2020 |
Total Antibody, CLIA | H, M | HCP, Recipients, IFU | None | |
10/30/2020 | Siemens Healthcare Diagnostics Inc. | Dimension EXL SARS-CoV-2 Total antibody assay (CV2T) 06/08/2020 |
Total Antibody, CLIA | H, M | HCP, Recipients, IFU | None | |
06/10/2020 | InBios International, Inc. | SCoV-2 Detect IgG ELISA 06/10/2020 |
IgG, ELISA | H | HCP, Recipients, IFU | None | None |
06/15/2020 | Emory Medical Laboratories | SARS-CoV-2 RBD IgG test 06/15/2020 |
IgG, ELISA | H | HCP, Recipients, EUA Summary | None | None |
10/17/2020 | Biohit Healthcare (Hefei) Co. Ltd. | Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit 06/18/2020 |
IgM and IgG Lateral Flow | H, M | HCP, Recipients, IFU | ThermoGenesis SARS-CoV-2 IgM/IgG Antibody Test Kit | |
12/02/2020 | Hangzhou Laihe Biotech Co., Ltd. | LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) 06/19/2020 |
IgM and IgG Lateral Flow | H, M | HCP, Recipients, IFU | QUICKKIT Novel Coronavirus (2019-nCov) IgM/IgG Antibody Combo Test Kit | |
06/23/2020 | Babson Diagnostics, Inc. | Babson Diagnostics aC19G1 06/23/2020 |
IgG, CLIA | H | HCP, Recipients, EUA Summary | None | None |
06/26/2020 | Beckman Coulter, Inc. | Access SARS-CoV-2 IgG 06/26/2020 |
IgG, CLIA | H, M | HCP, Recipients, IFU | None | None |
06/30/2020 | InBios International, Inc. | SCoV-2 Detect IgM ELISA 06/30/2020 |
IgM, ELISA | H | HCP, Recipients, IFU | None | None |
09/23/2020 | Assure Tech. (Hangzhou Co., Ltd) | Assure COVID-19 IgG/IgM Rapid Test Device 07/06/2020 |
IgM and IgG, Lateral Flow, Fingerstick Whole Blood | H, M, W | HCP, Recipients, IFU | None |
|
07/08/2020 | Diazyme Laboratories, Inc. | Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit 07/08/2020 |
IgG, CLIA | H, M | HCP, Recipients, IFU | None | None |
07/10/2020 | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | WANTAI SARS-CoV-2 Ab Rapid Test 07/10/2020 |
Total Antibody, Lateral Flow | H, M | HCP, Recipients, IFU | None | None |
01/05/2021 | Salofa Oy | Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette 07/13/2020 |
IgM and IgG, Lateral Flow, Fingerstick Whole Blood | H, M, W | HCP, Recipients, IFU | None |
|
07/16/2020 | Luminex Corporation | xMAP SARS-CoV-2 Multi-Antigen IgG Assay 07/16/2020 |
IgG, FMIA | H | HCP, Recipients, IFU | None | None |
07/17/2020 | Megna Health, Inc. | Rapid COVID-19 IgM/IgG Combo Test Kit 07/17/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Recipients, IFU | None | None |
11/06/2020 | Xiamen Biotime Biotechnology Co., Ltd. | BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test 07/24/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Recipients, IFU |
|
|
10/31/2020 | Access Bio, Inc. | CareStart COVID-19 IgM/IgG 07/24/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Recipients, IFU |
|
|
07/31/2020 | Siemens Healthcare Diagnostics Inc. | Atellica IM SARS-CoV-2 IgG (COV2G) 07/31/2020 |
IgG, Semi-quantitative | H, M |
HCP, Recipients, IFU |
None | None |
07/31/2020 | Siemens Healthcare Diagnostics Inc. | ADVIA Centaur SARS-CoV-2 IgG (COV2G) 07/31/2020 |
IgG, Semi-quantitative | H, M | HCP, Recipients, IFU | None | None |
08/05/2020 | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | WANTAI SARS-CoV-2 Ab ELISA 08/05/2020 |
Total Antibody, ELISA | H | HCP, Recipients, IFU | None | None |
08/06/2020 | bioMérieux SA | VIDAS SARS-CoV-2 IgM 08/06/2020 |
IgM, ELFA | H, M | HCP, Recipients, IFU | None | None |
08/06/2020 | bioMérieux SA | VIDAS SARS-CoV-2 IgG 08/06/2020 |
IgG, ELFA | H, M | HCP, Recipients, IFU | None | None |
08/17/2020 | BioCheck, Inc. | BioCheck SARS-CoV-2 IgG and IgM Combo Test 08/17/2020 |
IgM and IgG, CLIA | H, M | HCP, Recipients, IFU | None | None |
08/17/2020 | Diazyme Laboratories, Inc. | Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit 08/17/2020 |
IgM, CLIA | H, M | HCP, Recipients, IFU | None | None |
08/25/2020 | Biocan Diagnostics Inc. | Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test - Letter of Authorization 08/25/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Recipients, IFU | None | None |
08/31/2020 | TBG Biotechnology Corp. | TBG SARS-CoV-2 IgG / IgM Rapid Test Kit 08/31/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Recipients, IFU | None | None |
08/31/2020 | University of Arizona Genetics Core for Clinical Services | COVID-19 ELISA pan-Ig Antibody Test 08/31/2020 |
Total Antibody, ELISA | H | HCP, Recipients, EUA Summary | None | None |
09/03/2020 | Sugentech, Inc. | SGTi-flex COVID-19 IgG 09/03/2020 |
IgG, Lateral Flow | H, M | HCP, Recipients, IFU | None | None |
09/09/2020 | BioCheck, Inc. | BioCheck SARS-CoV-2 IgM Antibody Test Kit 09/09/2020 |
IgM, CLIA | H, M | HCP, Recipients, IFU | None | None |
09/09/2020 | BioCheck, Inc. | BioCheck SARS-CoV-2 IgG Antibody Test Kit 09/09/2020 |
IgG, CLIA | H, M | HCP, Recipients, IFU | None | None |
09/14/2020 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | MAGLUMI 2019-nCoV IgM/IgG 09/14/2020 |
IgM and IgG, CLIA | H, M | HCP, Recipients, IFU | None | None |
11/10/2020 | Jiangsu Well Biotech Co., Ltd. | Orawell IgM/IgG Rapid Test 09/23/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Recipients, IFU |
|
|
09/25/2020 | Quotient Suisse SA | MosaiQ COVID-19 Antibody Magazine 09/25/2020 |
Total Antibody, photometric immunoassay | H | HCP, Recipients, IFU | None | None |
09/29/2020 | DiaSorin, Inc. | DiaSorin LIAISON SARS-CoV-2 IgM Assay 09/29/2020 |
IgM, Indirect CLIA | H, M | HCP, Recipients, IFU | None | None |
09/29/2020 | NanoEntek America, Inc. | FREND COVID-19 total Ab 09/29/2020 |
Total Antibody, FIA | H, M | HCP, Recipients, IFU | None | None |
09/29/2020 | Nirmidas Biotech, Inc. | Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit 09/29/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Recipients, IFU | None | None |
10/06/2020 | Thermo Fisher Scientific | OmniPATH COVID-19 Total Antibody ELISA Test 10/02/2020 |
Total Antibody, ELISA | H, M | HCP, Recipients, IFU | None | None |
10/06/2020 | ZEUS Scientific, Inc. | ZEUS ELISA SARS-CoV-2 IgG Test System 10/06/2020 |
IgG, ELISA | H, M | HCP, Recipients, IFU | None | None |
10/08/2020 | Beckman Coulter, Inc. | Access SARS-CoV-2 IgM 10/08/2020 |
IgM, CLIA | H, M | HCP, Recipients, IFU | None | None |
10/08/2020 | Genalyte, Inc. | Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2 10/08/2020 |
Total Antibody, photonic ring immunoassay | H, M | HCP, Recipients, IFU | None | None |
10/09/2020 | Abbott Laboratories Inc. | AdviseDx SARS-CoV-2 IgM 10/09/2020 | IgM, CMIA | H, M | None | None | |
10/28/2020 | Quansys Biosciences, Inc. | Q-Plex SARS-CoV-2 Human IgG (4 Plex) 10/28/2020 | IgG, CLIA | H | HCP, Recipients, IFU | None | None |
11/06/2020 | GenScript USA Inc. | cPass SARS-CoV-2 Neutralization Antibody Detection Kit 11/06/2020 | Total Neutralizing Antibodies, Blocking ELISA | H | HCP, Recipients, IFU | None | None |
11/24/2020 | Kantaro Biosciences, LLC | COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit 11/24/2020 |
IgG, ELISA, Semi-quantitative | H | HCP, Recipients, IFU | None | None |
11/25/2020 | Roche Diagnostics, Inc. | Elecsys Anti-SARS-CoV-2 S 11/25/2020 |
Total Antibody, ECLIA, Semi-quantitative | H, M | HCP, Recipients, IFU | None | None |
11/23/2020 | Innovita (Tangshan) Biological Technology Co., Ltd. | Innovita 2019-nCoV Ab Test (Colloidal Gold) 11/23/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Recipients, IFU | None | None |
12/15/2020 | ACON Laboratories, Inc. | ACON SARS-CoV-2 IgG/IgM Rapid Test 12/15/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Recipients, IFU | None | None |
12/23/2020 | Quanterix Corporation | Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test 12/23/2020 |
IgG, Paramagnetic Microbead-based Sandwich ELISA, Semi-quantitative | H, M | HCP, Recipients, IFU | None | None |
12/31/2020 | Nirmidas Biotech, Inc. | MidaSpot COVID-19 Antibody Combo Detection Kit 12/31/2020 |
IgM and IgG, lateral flow, Fingerstick Whole Blood | H, M, W | HCP, Recipients, IFU | None | None |
01/08/2021 | Siemens Healthcare Diagnostics Inc. | Dimension EXL SARS‑CoV‑2 IgG (CV2G) 01/08/2021 |
IgG, CLIA, Semi-quantitative | H, M | HCP, Recipients, IFU | None | None |
01/08/2021 | Siemens Healthcare Diagnostics Inc. | Dimension Vista SARS‑CoV‑2 IgG (COV2G) 01/08/2021 |
IgG, CLIA, Semi-quantitative | H, M | HCP, Recipients, IFU | None | None |
01/11/2021 | ADVAITE, Inc. | RapCov Rapid COVID-19 Test 01/11/2021 |
IgG, Lateral Flow, Fingerstick Whole Blood | H, M, W | HCP, Recipients, IFU | None | None |
01/11/2021 | Phadia AB | EliA SARS-CoV-2-Sp1 IgG Test 01/11/2021 |
IgG, Fluoroenzyme Immunoassay, Semi-quantitative | H, M | HCP, Recipients, IFU | None | None |
01/15/2021 | United Biomedical, Inc. | UBI SARS-CoV-2 ELISA 01/15/2021 |
IgG, ELISA | H | HCP, Recipients, IFU | None | None |
1 Authorized settings include the following:
- H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
- M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
- W - Patient care settings operating under a CLIA Certificate of Waiver.
2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.
3 Abbreviations: CLIA = chemiluminescence immunoassay; ELISA = enzyme-linked immunosorbent assay; ECLIA = electrochemiluminescence immunoassay; FMIA = fluorescent microsphere Immunoassay, CMIA = chemiluminescent microparticle immunoassay; ELFA = enzyme-linked fluorescence assay
Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2
On April 28, 2020, FDA issued an umbrella EUA for SARS-CoV-2 Antibody Tests (Lateral flow or Enzyme-linked immunosorbent assay (ELISA) tests) that have been evaluated in an independent validation study performed at the National Institutes of Health's (NIH) National Cancer Institute (NCI), or by another government agency designated by the FDA, and are confirmed by the FDA to meet the criteria set forth in the Scope of Authorization of the EUA. To date, however, no device has been added to the list of authorized devices in Appendix A of the letter of authorization.
On July 21, 2020, FDA determined, based on information and experience since issuing this EUA, that circumstances support revocation of this umbrella EUA so that FDA may issue individual EUAs. Individual EUAs will allow for broader indications and scopes of authorization, individualized conditions of authorization to address any issue unique to a specific test, and more streamlined EUA amendments, such as additional uses that would not fall under this umbrella EUA.
Accordingly, the EUA was revoked under Section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
Individual EUAs For IVDs for Management of COVID-19 Patients
This table includes information about authorized in vitro diagnostic tests that may be used in the management of patients with COVID-19 that have been authorized individually. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories.
Date EUA Issued or Last Updated | Entity | Diagnostic (Most Recent Letter of Authorization) and Date EUA Originally Issued | Attributes | Authorized Setting(s)1 | Authorization Documents2 | Other Documents | Other Brand Name(s) |
---|---|---|---|---|---|---|---|
06/02/2020 | Roche Diagnostics | Elecsys IL-6 06/02/2020 |
Immunoassay-IL-6 | H, M | HCP, Patients, IFU | None | None |
10/01/2020 | Beckman Coulter, Inc. | Access IL-6 10/01/2020 |
One-step immunoenzymatic ("sandwich") assay, IL-6 | H, M | HCP, Patients, IFU | None | None |
12/18/2020 | Siemens Healthcare Diagnostics Inc. | ADVIA Centaur IL6 assay 12/18/2020 |
One-step Direct Chemiluminescent Immunoassay | H, M | HCP, Patients, IFU | None | None |
1 Authorized settings include the following:
- H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
- M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
- W - Patient care settings operating under a CLIA Certificate of Waiver.
2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.
Additional Resources
- Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff
- Insight into FDA's Revised Policy on Antibody Tests: Prioritizing Access and Accuracy
- FAQs on Testing for SARS-CoV-2
- EUA Authorized Serology Test Performance