In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2
In Vitro Diagnostic EUAs: Overview and Templates
On This Page:
- Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2
- Pooling and Serial Testing Amendment for Certain 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 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. Test attributes are listed in the "Attributes" column. For example, tests authorized for the screening of asymptomatic individuals without known exposure are listed with "screening" in the attribute column; pooling, multi-analyte, saliva, home collection, and home testing are similarly listed. Tests available without a prescription include the attribute "DTC" (for direct-to-consumer home collection tests) or "OTC" (for over-the-counter at-home tests).
Molecular SARS-CoV-2 Diagnostic Tests for COVID-19 that have been granted a De Novo, 510(k) clearance or PMA
- BioFire Respiratory Panel 2.1 (RP2.1) - On March 17, 2021, FDA granted the first marketing authorization using the De Novo review pathway for the BioFire Respiratory Panel 2.1 (RP2.1) (PDF - 630 KB). The BioFire RP2.1 is for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections, including COVID-19. Also see the FDA news release: FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process. With granting of the De Novo for the BioFire RP2.1, the FDA revoked the EUA for this device, which was initially authorized for emergency use in May 2020.
The BioFire Respiratory Panel 2.1 (RP2.1) was reviewed under the De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing criteria, called special controls, that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA's 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.
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) |
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02/09/2021 | 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 | |
03/29/2021 | 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 | |
04/01/2021 | 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 | |
04/21/2021 | Quidel Corporation | Lyra SARS-CoV-2 Assay 03/17/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
05/11/2021 | 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 (Home Collect) |
None | |
01/22/2021 | Hologic, Inc. | Panther Fusion SARS-CoV-2 Assay 03/16/2020 |
Real-time RT-PCR, Pooling, Screening | H | HCP, Patients, IFU | None | |
02/23/2021 | Thermo Fisher Scientific, Inc. | TaqPath COVID-19 Combo Kit 03/13/2020 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, IFU | None | |
04/12/2021 | Roche Molecular Systems, Inc. (RMS) | cobas SARS-CoV-2 03/12/2020 |
Real-time RT-PCR, Pooling, Screening | H, M, H-Pooling | HCP, Patients, IFU | None | |
02/03/2021 | Mesa Biotech Inc. | Accula SARS-Cov-2 Test 03/23/2020 |
RT and amplification | H, M, W | HCP, Patients, IFU | None | |
05/06/2021 | BioFire Defense, LLC | BioFire COVID-19 Test 03/23/2020 |
RT, Nested multiplex PCR, Pooling | H, M | HCP, Patients, IFU | None | |
04/01/2021 | 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 |
01/22/2021 | NeuMoDx Molecular, Inc. | NeuMoDx SARS-CoV-2 Assay 03/30/2020 |
RT-PCR, Collection Kit, Saliva | H, M | HCP, Patients, IFU, IFU (Collect) | 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 | |
02/03/2021 | DiaCarta, Inc | QuantiVirus SARS-CoV-2 Test kit 04/08/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
04/29/2021 | Becton, Dickinson and Company (BD) | BD SARS-CoV-2 Reagents for BD MAX System 04/08/2020 |
Real-time RT-PCR, Serial Screening | 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 | |
04/15/2021 | 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 | |
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 |
04/07/2021 | 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 | |
04/20/2021 | OPTI Medical Systems, Inc. | OPTI SARS-CoV-2 RT PCR Test 05/06/2020 |
Real-time RT-PCR, Screening, Pooling | 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 | |
03/11/2021 | 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 | |
05/11/2021 | Applied DNA Sciences, Inc. | Linea COVID-19 Assay Kit 05/13/2020 |
Real-time RT-PCR, Serial Screening | H | HCP, Patients, IFU | None | |
03/26/2021 | Hologic, Inc. | Aptima SARS-CoV-2 assay 05/14/2020 |
TMA, chemiluminescent, Pooling, Screening | H | HCP, Patients, IFU | None | |
01/26/2021 | GeneMatrix, Inc. | NeoPlex COVID-19 Detection Kit 05/14/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
04/12/2021 | Fulgent Therapeutics | 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 |
01/26/2021 | Quidel Corporation | Lyra Direct SARS-CoV-2 Assay 05/18/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
04/01/2021 | P23 Labs, LLC. | P23 Labs TaqPath SARS-CoV-2 Assay 05/21/2020 |
Real-time RT-PCR, Home Collection, Saliva | H | HCP, Patients, IFU1 (Home Collect), IFU2 (Home Collect) EUA Summary |
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02/23/2021 | 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 | |
03/18/2021 | LetsGetChecked, Inc. | LetsGetChecked Coronavirus (COVID-19) Test 05/28/2020 |
Direct to Consumer (DTC), TMA, chemiluminescent, Home Collection, Screening | H | HCP, Individuals, 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 | |
03/01/2021 | 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 |
04/22/2021 | Euroimmun US, Inc. | EURORealTime SARS-Cov-2 06/08/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | |
04/22/2021 | 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 | |
03/26/2021 | Cue Health Inc. | Cue COVID-19 Test 06/10/2020 |
RT, Isothermal amplification, Screening | 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 | |
03/31/2021 | 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 |
05/10/2021 | 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 |
01/29/2021 | 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 |
02/03/2021 | PlexBio Co., Ltd. | IntelliPlex SARS-CoV-2 Detection Kit 06/25/2020 |
RT-PCR | H | HCP, Patients, IFU | None | |
06/26/2020 | Inform Diagnostics, Inc. | Inform Diagnostics SARS-CoV-2 RT-PCR Assay 06/26/2020 |
Real-time RT-PCR | 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 |
02/13/2021 | The Kroger Co. | Kroger Health COVID-19 Test Home Collection Kit 06/30/2020 |
Home Collection Kit, Direct to Consumer (DTC), Screening | N/A | Individuals, IFU, EUA Summary | None | 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 |
02/05/2021 | Access Bio, Inc. | CareStart COVID-19 MDx RT-PCR 07/07/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU |
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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 |
04/07/2021 | 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 |
04/14/2021 | Color Health, Inc. | Color SARS-CoV-2 RT-LAMP Diagnostic Assay 05/18/2020 |
RT, LAMP, Home Collection, Screening | 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 | |
01/29/2021 | 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., Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
01/19/2021 | Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute | Cleveland Clinic SARS-CoV-2 Assay 08/03/2020 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | 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 |
01/28/2021 | 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 |
04/09/2021 | Yale School of Public Health, Department of Epidemiology of Microbial Diseases | SalivaDirect 08/15/2020 |
Real-time RT-PCR, Saliva, Serial Screening | 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 |
02/26/2021 | Fluidigm Corporation | Advanta Dx SARS-CoV-2 RT-PCR Assay 08/25/2020 |
Real-time RT-PCR, Saliva, Home Collection | H | HCP, Patients, IFU, IFU (Home Collect) | None | |
02/08/2021 | 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 | |
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 |
04/27/2021 | 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 | |
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 |
01/28/2021 | 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 |
03/19/2021 | Color Health, Inc. | Color COVID-19 Self-Swab Collection Kit 08/31/2020 |
Home Collection Kit, Screening | N/A | 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 |
|
|
04/01/2021 | 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 |
04/01/2021 | 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 |
05/06/2021 | Quadrant Biosciences Inc. | Clarifi COVID-19 Test Kit 09/22/2020 |
Real-time RT-PCR, Saliva, Pooling | 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 |
01/27/2021 | 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 | |
04/27/2021 | 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 |
04/02/2020 | Alimetrix, Inc. | Alimetrix SARS-CoV-2 RT-PCR Assay 09/30/2020 |
RT-PCR, Microarray Hybridization, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
03/24/2021 | Tempus Labs, Inc. | iC SARS-CoV2 Test 10/01/2020 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | 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 |
04/27/2021 | 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 | |
04/29/2021 | 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 |
03/29/2021 | LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 RNA STAR Complete 10/14/2020 |
RT, qSTAR amplification | H | HCP, Patients, IFU | None | |
02/26/2021 | Clinical Enterprise, Inc. | EmpowerDX COVID-19 Home Collection Kit DTC 10/15/2020 |
Home Collection Kit, Direct to Consumer (DTC), Screening | N/A | EUA Summary, Individuals, IFU | None | None |
02/26/2021 | Viracor Eurofins Clinical Diagnostics | Viracor SARS-CoV-2 assay 04/06/2020 | Real-Time RT-PCR, Pooling, Screening | H | HCP, Patients, EUA Summary | None | None |
03/02/2021 | binx health, Inc. | binx health At-Home Nasal Swab COVID-19 Sample Collection Kit 10/20/2020 |
Home Collection Kit | N/A | EUA Summary, IFU | None | None |
05/04/2021 | 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 | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | None |
01/22/2021 | Express Gene LLC, DBA: Express Gene Molecular Diagnostics Laboratory | Express Gene 2019-nCoV RT-PCR Diagnostic Panel 05/22/2020 |
Real-time RT-PCR, Collection Kit, Saliva | 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 |
04/01/2021 | Gravity Diagnostics, LLC | Gravity Diagnostics SARS-CoV-2 RT-PCR Assay 11/23/2020 |
Real-time RT-PCR, Home Collection, Saliva, Screening | 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 | H | HCP, Patients, EUA Summary, IFU (Home Collection) | None | None |
04/20/2021 | Cepheid | Xpert Omni SARS-CoV-2 11/27/2020 |
Real-time RT-PCR | H, M, W | 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 |
05/11/2021 | 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 |
05/10/2021 | 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 | |
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 |
05/06/2021 | Hologic, Inc. | Aptima SARS-CoV-2/Flu assay 12/16/2020 |
Real-time TMA, chemiluminescent, Multi-analyte | H | HCP, Patients, IFU | 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 |
03/25/2021 | Quidel Corporation | Solana SARS-CoV-2 Assay 12/23/2020 |
Isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA) | H, M | HCP, Patients, IFU | 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 |
04/30/2021 | SML GENETREE Co., Ltd. | Ezplex SARS-CoV-2 G Kit 01/13/2021 |
Real-time RT-PCR, Pooling | H | HCP, Patients, IFU | None | |
05/06/2021 | 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 |
04/29/2021 | Ambry Genetics Laboratory | Ambry COVID-19 RT-PCR Test 01/22/2021 |
Real-time RT-PCR, Home Collection, Saliva | H | HCP, Patients, IFU (Home Collect), EUA Summary | None | |
01/19/2021 | Hospital of the University of Pennsylvania | BD MAX COVID-19 ASSAY (Authorized by HHS/OASH) 01/19/2021 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
01/19/2021 | INNO Diagnostics Reference Laboratory, Ponce Medical School | PMSF-INNO SARS-CoV-2 RT-PCR Test (Authorized by HHS/OASH) 01/19/2021 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
02/04/2021 | Clinomics USA Inc. | Clinomics TrioDx RT-PCR COVID-19 Test 02/04/2021 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
02/08/2021 | Visby Medical, Inc. | Visby Medical COVID-19 Point of Care Test 02/08/2021 |
RT-PCR | H, M, W | HCP, Patients, IFU, IFU (Collect) | None | None |
02/11/2021 | Bio-Rad Laboratories, Inc. | Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit 02/11/2021 |
Real-time RT-PCR, Multi-analyte | H | HCP, Patients, IFU | None | None |
04/29/2021 | Becton, Dickinson and Company (BD) | BD SARS-CoV-2/Flu for BD MAX System 02/10/2021 |
Real-time RT-PCR, Multi-analyte | H, M | HCP, Patients, IFU | None | |
02/10/2021 | Thermo Fisher Scientific | TaqPath COVID-19, FluA, FluB Combo Kit 02/10/2021 |
Real-time RT-PCR, Multi-analyte | H | HCP, Patients, IFU | None | None |
02/10/2021 | Grifols Diagnostic Solutions Inc. | Procleix SARS-CoV-2 Assay 02/10/2021 |
TMA | H | HCP, Patients, IFU | None | None |
05/10/2021 | Gravity Diagnostics, LLC | Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits 02/13/2021 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening | H | HCP, Individuals, EUA Summary | None | None |
02/13/2021 | Assurance Scientific Laboratories | Assurance SARS-CoV-2 Panel DTC 02/13/2021 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening | H | HCP, Individuals, EUA Summary, IFU (Home Collect) | None | None |
02/13/2021 | Everlywell, Inc. | Everlywell COVID-19 Test Home Collection Kit DTC 02/13/2021 |
Home Collection Kit, Direct to Consumer (DTC), Screening | N/A | Individuals, EUA Summary, IFU (Home Collect) | None | None |
04/02/2021 | University of Illinois Office of the Vice President for Economic Development and Innovation | covidSHIELD 02/24/2021 |
Real-time RT-PCR, Saliva, Serial Screening | H | HCP, Patients, EUA Summary | None | None |
02/26/2021 | Viracor Eurofins Clinical Diagnostics | Viracor SARS-CoV-2 assay DTC 02/26/2021 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening | H | HCP, Individuals, EUA Summary | None | None |
03/05/2021 | Cue Health Inc. | Cue COVID-19 Test for Home and Over The Counter (OTC) Use 03/05/2021 |
RT, Isothermal amplification, Over the Counter (OTC) Home Testing, Screening | Home, H, M, W | HCP, Individuals, IFU, IFU (Home Test), FAQ | None | None |
03/04/2021 | Abbott Molecular Inc. | Alinity m Resp-4-Plex 03/04/2021 |
Real-time RT-PCR, Multi-analyte | H, M | HCP, Patients, IFU | None | None |
03/03/2021 | Luminex Molecular Diagnostics, Inc. | NxTAG Respiratory Pathogen Panel + SARS-CoV-2 03/03/2021 |
RT-PCR, Multi-analyte | H | HCP, Patients, IFU | None | None |
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) 03/05/2021 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
03/09/2021 | GetMyDNA | GetMyDNA COVID-19 Test Home Collection Kit 03/09/2021 |
Home Collection Kit, Direct to Consumer (DTC), Screening | N/A | EUA Summary, Individuals, IFU | None | None |
03/19/2021 | Color Health, Inc. | Color COVID-19 Self-Swab Collection Kit DTC 03/19/2021 |
Home Collection Kit, Direct to Consumer (DTC), Screening | N/A | EUA Summary, Individuals, IFU | None | None |
03/19/2021 | Color Health, Inc. | Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC 03/19/2021 |
Direct to Consumer (DTC), RT, LAMP, Home Collection, Screening | H | EUA Summary, Individuals, HCP | None | None |
03/23/2021 | Twist Bioscience Corporation | SARS-CoV-2 NGS Assay 03/23/2021 |
Sequencing | H | HCP, Patients, IFU | None | None |
04/23/2021 | NeuMoDx Molecular, Inc. | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay 03/25/2021 |
Real-time RT-PCR, Multi-analyte | H, M | HCP, Patients, IFU | None | None |
04/16/2021 | STS Lab Holdco (a subsidiary of Amazon.com Services LLC) | Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 03/25/2021 |
Real-time RT-PCR, Home Collection, Pooling, Screening | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
01/19/2021 | University of Louisville Infectious Diseases Laboratory | SARS-CoV-2 real time RT-PCR test (Authorized by HHS/OASH) 01/19/2021 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | None |
04/09/2021 | Lucira Health, Inc. | Lucira CHECK-IT COVID-19 Test Kit 04/09/2021 |
RT, LAMP, Over the Counter (OTC) Home Testing, Screening | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | None |
04/09/2021 | Thermo Fisher Scientific | Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit 04/09/2021 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None |
04/12/2021 | PerkinElmer Genomics | PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit 04/12/2021 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary | None | None |
04/13/2021 | Clinical Enterprise, Inc. | Clinical Enterprise SARS-CoV-2 RT-PCR Assay 04/13/2021 |
Real-time RT-PCR, Screening | H | HCP, Patients, EUA Summary | None | None |
04/13/2021 | Clinical Enterprise, Inc. | Clinical Enterprise SARS-CoV-2 RT-PCR Assay DTC 04/13/2021 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening | H | HCP, Individuals, EUA Summary | None | None |
05/06/2021 | Yale School of Public Health, Department of Epidemiology of Microbial Diseases | SalivaDirect At-Home Collection Kit 04/09/2021 |
Home Collection Kit, Saliva, Screening | N/A | EUA Summary, IFU-1, IFU-2 | None | |
04/16/2021 | Color Health, Inc. | Color COVID-19 Self-Swab Collection Kit with Saline 04/14/2021 |
Home Collection Kit, Screening | N/A | EUA Summary, IFU | None | None |
04/15/2021 | LGC, Biosearch Technologies | Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test 04/15/2021 |
Real-Time and End-Point RT-PCR | H | HCP, Patients, IFU | None | None |
04/16/2021 | Synergy Diagnostic Laboratory, Inc., DBA SynergyDx | SynergyDx SARS-CoV-2 RNA Test DTC 04/16/2021 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening | H | HCP, Individuals, EUA Summary, IFU (Home Collect) | None | None |
04/16/2021 | Synergy Diagnostic Laboratory, Inc., DBA SynergyDx | SynergyDx SARS-CoV-2 RNA Test 04/16/2021 |
Real-time RT-PCR, Home Collection, Screening | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
04/20/2021 | Southern California Permanente Medical Group | Kaiser Permanente High Throughput SARS-CoV-2 Assay 04/19/2021 |
Real-Time RT-PCR, Saliva, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
04/20/2021 | PathogenDx, Inc. | DetectX-Rv 04/20/2021 |
RT-PCR, DNA Microarray Hybridization | 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;
Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2
On April 20, 2021, the FDA issued an amendment allowing certain authorized molecular diagnostic SARS-CoV-2 tests to be distributed and used to pool anterior nasal respiratory specimens from asymptomatic individuals as part of a serial testing program after developers submit a complete notification, including meeting required validation data, as set forth in the letter. Use of tests for these indications is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, except that tests authorized for use in specific named or designated high complexity laboratories can only be used in such laboratories.
This means that tests with EUAs that are amended by this authorization may be used with pooled anterior nasal specimens from individuals without known or suspected COVID-19 when such individuals are tested as part of a testing program that includes testing at regular intervals, at least once per week. The indications in each appendix (A-H) differ in the number of specimens that can be pooled (up to 3, up to 5, or up to 10) and the type of pooling that can be done (media pooling or swab pooling).
Prior to a test being distributed or used for any new indication, the developer must submit a notification to the FDA with the information required by the amendment, including self-certifying that the applicable validation has been completed. Tests will be added to Exhibit 1 once FDA confirms that the required documentation has been submitted. Please note that being added to Exhibit 1 does not necessarily mean that the FDA has reviewed the underlying validation data submitted or confirmed that the test is appropriately validated.
- Amendment Letter
- Appendix J - Sample Updated Fact Sheet for Health Care Providers
- Appendix K - Sample Updated Fact Sheet for Patients
Exhibit 1 of the Pooling and Serial Testing Amendment
Tests for SARS-CoV-2 that can be used for pooling as part of a serial testing program under this amendment will be added to this Exhibit.
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) |
04/06/2021 | 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 |
01/28/2021 | 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 |
01/29/2021 | 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 |
02/03/2021 | 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.