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
- Revision Concerning Viral Mutation
- Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2
- Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing
- 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). To see additional authorization documents, such as letters granting EUA amendments or revisions, and a list of other brand names authorized under a specific EUA, select the plus (+) button beside the “Date EUA Issued or Last Updated” for the EUA.
For information on tests that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD)
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.
Authorized Molecular Diagnostic Tests for SARS-CoV-2 are assigned the QJR product code. Authorized Home Collection Kits are assigned the QLW product code. Authorized EUAs for Multi-analyte Respiratory Panel Tests are assigned the QLT product code.
Date EUA Issued or Last Updated | Entity | Diagnostic (Most Recent Letter of Authorization) and Date EUA Original Issue | Attributes3 | Authorized Setting(s)1 | Authorization Documents2 | Other Documents | Other Brand Name(s) | |
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11/09/2021 | Meridian Bioscience, Inc. | Revogene SARS-CoV-2 11/09/2021 |
Real time RT-PCR | H, M | HCP, Patients, IFU | None | None | |
11/10/2021 | Talis Biomedical Corporation | Talis One COVID-19 Test System 11/05/2021 |
RT, Isothermal amplification | H, M, W | HCP, Patients, IFU | None | None | |
10/28/2021 | Detect, Inc. | Detect Covid-19 Test 10/28/2021 | RT, LAMP, Lateral Flow Strips, Over the Counter (OTC) Home Testing, Serial Screening | Home, H, M, W | HCP, Individuals, IFU, IFU (Home Test) | None | None | |
11/01/2021 | PerkinElmer, Inc. | PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 10/06/2021 |
Real-time RT-PCR, Multi-analyte | H | HCP, Patients, IFU | None | ||
10/20/2021 | Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute | SelfCheck cobas SARS-CoV-2 Assay 09/29/2021 |
Real-time RT-PCR, Home Collection, Screening | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None | |
10/08/2021 | Quest Diagnostics Infectious Disease, Inc. | Quest Diagnostics Collection Kit for COVID-19 10/08/2021 |
Home Collection Kit | N/A | EUA Summary, IFU | None | None | |
09/30/2021 | Laboratory Corporation of America (Labcorp) | Labcorp SARS-CoV-2 & Influenza A/B Assay 9/30/2021 |
Real-time RT-PCR, Multi-analyte, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None | |
10/20/2021 | Cepheid | Xpert Xpress CoV-2/Flu/RSV plus 09/10/2021 | Real-time RT-PCR, Multi-analyte | H, M, W | HCP, Patients, IFU for Labs, IFU for Point-of-Care | None | ||
10/29/2021 | Yale School of Public Health, Department of Epidemiology of Microbial Diseases | SalivaDirect for use with DTC Kits 08/27/2021 | Direct to Consumer (DTC), Real-time RT-PCR, Saliva, Home Collection, Screening, Pooling | H | HCP, Individuals, EUA Summary | None | None | |
08/27/2021 | Yale School of Public Health, Department of Epidemiology of Microbial Diseases | SalivaDirect DTC Saliva Collection Kit 08/27/2021 |
Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening | N/A | Individual, IFU-1, IFU-2, EUA Summary | None | None | |
08/25/2021 | Empire City Laboratories | ECL COVID TEST SYSTEM-1 08/25/2021 | Real-time RT-PCR, Home Collection | H | HCP, Patients, IFU (Home Collect), EUA Summary | None | None | |
08/25/2021 | Empire City Laboratories | ECL COVID TEST SYSTEM 08/25/2021 | Real-time RT-PCR, Home Collection | H | HCP, Patients, IFU (Home Collect), EUA Summary | None | None | |
08/23/2021 | The Mount Sinai Hospital, Center for Clinical Laboratories | Mount Sinai SARS-CoV-2 Assay 08/23/2021 | Real-time RT-PCR, Home Collection, Saliva, Screening | H | HCP, Patients, IFU (Home Collect), EUA Summary | None | None | |
08/11/2021 | STS Lab Holdco (a subsidiary of Amazon.com Services LLC) | Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test 08/11/2021 |
Real-time RT-PCR, Home Collection, Pooling, Screening | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None | |
08/11/2021 | STS Lab Holdco (a subsidiary of Amazon.com Services LLC | Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test 08/11/2021 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening | H | HCP, Individuals, EUA Summary, IFU (Home Collect), FAQ | None | None | |
08/09/2021 | Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute | SelfCheck COVID-19 TaqPath Multiplex PCR 08/09/2021 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None | |
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 | ||
07/15/2021 | altona Diagnostics GmbH | RealStar SARS-CoV02 RT-PCR Kits U.S. 04/22/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | ||
07/21/2021 | 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 | ||
05/20/2021 | Wadsworth Center, New York State Department of Public Health | New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel 02/29/2020 |
Real-time RT-PCR | 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 | ||
07/22/2021 | DiaSorin Molecular LLC | Simplexa COVID-19 Direct assay 03/19/2020 |
Real-time RT-PCR | H, M | HCP, Patients, IFU | None | ||
11/22/2021 | Abbott Molecular Inc. | Abbott RealTime SARS-CoV-2 assay 03/18/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | ||
10/08/2021 | 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 | 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 | ||
07/23/2021 | Hologic, Inc. | Panther Fusion SARS-CoV-2 Assay 03/16/2020 |
Real-time RT-PCR, Pooling, Screening | H | HCP, Patients, IFU | None | ||
10/12/2021 | Thermo Fisher Scientific, Inc. | TaqPath COVID-19 Combo Kit 03/13/2020 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, IFU |
|
None | |
10/20/2021 | 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 | ||
08/25/2021 | BioFire Defense, LLC | BioFire COVID-19 Test 03/23/2020 |
RT, Nested multiplex PCR, Pooling, Saliva | H, M | HCP, Patients, IFU | None | ||
12/10/2021 | PerkinElmer, Inc. | PerkinElmer New Coronavirus Nucleic Acid Detection Kit 03/24/2020 |
Real-time RT-PCR, Pooling, Screening, Saliva | 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 | ||
08/27/2021 | Abbott Diagnostics Scarborough, Inc. | ID NOW COVID-19 03/27/2020 |
RT, Isothermal amplification | H, M, W | HCP, Patients, IFU | None | ||
07/29/2021 | QIAGEN GmbH | QIAstat-Dx Respiratory SARS-CoV-2 Panel 03/30/2020 |
Real-time RT-PCR, Multi-analyte | 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 | ||
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 | ||
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 | ||
05/21/2021 | 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 | ||
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 | ||
04/16/2020 | GenoSensor, LLC | GS"¢ COVID-19 RT-PCR KIT 04/16/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | 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 | ||
06/24/2021 | OSANG Healthcare | GeneFinder COVID-19 Plus RealAmp Kit 04/18/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | 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 | ||
07/01/2021 | Rheonix, Inc. | Rheonix COVID-19 MDx Assay 04/29/2020 |
RT-PCR, Saliva | H | HCP, Patients, IFU | 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 | ||
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 | ||
11/06/2020 | BioMérieux SA | SARS-COV-2 R-GENE 05/06/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | ||
08/18/2021 | Infinity BiologiX LLC | Infinity BiologiX TaqPath SARS-CoV-2 Assay 04/10/2020 |
Real-time RT-PCR, Home Collection, Saliva, Pooling | 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 | ||
05/11/2020 | 1drop Inc. | 1copy COVID-19 qPCR Multi Kit 05/11/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | ||
11/05/2021 | Abbott Molecular Inc. | Alinity m SARS-CoV-2 assay 05/11/2020 |
Real-time RT-PCR, Pooling, Screening | H, M | HCP, Patients, IFU | None | ||
07/21/2021 | Applied DNA Sciences, Inc. | Linea COVID-19 Assay Kit 05/13/2020 |
Real-time RT-PCR, Serial Screening | H | HCP, Patients, IFU | None | ||
10/26/2021 | 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 | ||
06/22/2021 | Fulgent Therapeutics | Fulgent COVID-19 by RT-PCR Test 05/15/2020 |
Real-time RT-PCR, Home Collection, Screening | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | ||
06/03/2021 | Everlywell, Inc. | Everlywell COVID-19 Test Home Collection Kit 05/15/2020 |
Home Collection Kit | N/A | IFU, EUA Summary | None | ||
09/02/2021 | Assurance Scientific Laboratories | Assurance SARS-CoV-2 Panel 05/15/2020 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary | None | ||
05/25/2021 | 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 | ||
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 | ||
08/18/2021 | INVITES BIOCORE CO., LTD. | BioCore 2019-nCoV Real Time PCR Kit 05/21/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | ||
08/11/2020 | dba SpectronRX | Hymon SARS-CoV-2 Test Kit 05/22/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | ||
11/01/2021 | LetsGetChecked, Inc. | LetsGetChecked Coronavirus (COVID-19) Test 05/28/2020 |
Direct to Consumer (DTC), TMA, chemiluminescent, Home Collection, Screening, Pooling | H | HCP, Individuals, EUA Summary, IFU (Home Collect) | None | ||
05/17/2021 | Phosphorus Diagnostics LLC | Phosphorus COVID-19 RT-qPCR Test 06/04/2020 |
Real-time RT-PCR, Home Collection, Saliva, Screening | H | HCP, Patients, EUA Summary, IFU (Home Collect), IFU (Clinic) |
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05/20/2021 | Genetron Health (Beijing) Co., Ltd. | Genetron SARS-CoV-2 RNA Test 06/05/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | 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 | ||
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 | ||
08/27/2021 | 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 | ||
06/08/2021 | Applied BioCode, Inc. | BioCode SARS-CoV-2 Assay 06/15/2020 |
RT-PCR, Pooling | H | HCP, Patients, IFU | None | ||
06/17/2021 | 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 | ||
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 | ||
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 | ||
06/24/2021 | 3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd. | TRUPCR SARS-CoV-2 Kit 06/18/2020 |
Real-time RT-PCR, Saliva | 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 | ||
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 | ||
08/26/2021 | Gencurix, Inc. | GenePro SARS-CoV-2 Test 06/23/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | None | |
11/29/2021 | 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 | ||
01/29/2021 | Diagnostic Solutions Laboratory, LLC | DSL COVID-19 Assay 06/25/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | 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 | ||
08/19/2021 | 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 | ||
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 | ||
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 | ||
09/21/2020 | Psomagen, Inc. | Psoma COVID-19 RT Test 06/30/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | ||
05/28/2021 | BioTNS Co. Ltd. | COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit 06/30/2020 |
RT-PCR | H | HCP, Patients, IFU | None | ||
05/19/2021 | The Kroger Co. | Kroger Health COVID-19 Test Home Collection Kit 06/30/2020 |
Home Collection Kit, Direct to Consumer (DTC), Screening | N/A | Individuals, IFU, EUA Summary | None | ||
08/13/2021 | CENTOGENE US, LLC | CentoFast-SARS-CoV-2 RT-PCR Assay 07/01/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | ||
08/05/2021 | Centers for Disease Control and Prevention (CDC) | Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay 07/02/2020 |
Real-time RT-PCR, Multi-analyte | 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 | ||
07/16/2021 | Enzo Life Sciences, Inc. | AMPIPROBE SARS-CoV-2 Test System 07/07/2020 |
Real-time RT-PCR, Pooling | H | HCP, Patients, IFU |
None |
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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 | ||
06/10/2021 | 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 07/08/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | ||
07/09/2020 | UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin | SARS-CoV-2 RNA DETECTR Assay 07/09/2020 |
RT-LAMP | H | HCP, Patients, EUA Summary | None | ||
12/28/2020 | BioSewoom, Inc. | Real-Q 2019-nCoV Detection Kit 07/09/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | 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 | |
06/25/2021 | 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 | ||
10/08/2021 | 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 | None | ||
10/08/2021 | 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 | None | ||
10/08/2021 | Quest Diagnostics Infectious Disease, Inc. | Quest Diagnostics HA SARS-CoV-2 Assay 07/15/2020 |
TMA, chemiluminescent, Home Collection | H | HCP, Patients, EUA Summary | None | ||
09/21/2020 | Boston Heart Diagnostics | Boston Heart COVID-19 RT-PCR Test 07/16/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | ||
07/28/2021 | Access Genetics, LLC | OraRisk COVID-19 RT-PCR 07/17/2020 |
Real-time RT-PCR, Home Collection | 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 | ||
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 | ||
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 | ||
07/09/2021 | 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 | ||
07/30/2020 | Clinical Reference Laboratory, Inc. | CRL Rapid Response 07/30/2020 |
Real-time RT-PCR, Home Collection, Saliva | H | 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 | ||
06/17/2021 | WREN Laboratories LLC | WREN Laboratories COVID-19 PCR Test 08/03/2020 |
Real-time RT-PCR, Home Collection, Saliva, Screening | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | ||
09/21/2020 | Ethos Laboratories | Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay 08/03/2020 |
RT-PCR and MALDI-TOF Mass Spec., Home Collection | 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 | ||
08/03/2020 | Poplar Healthcare | Poplar SARS-CoV-2 TMA Pooling assay 08/03/2020 |
TMA, chemiluminescent, Pooling | H | HCP, Patients, EUA Summary | 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 | ||
07/14/2021 | 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 | ||
06/24/2021 | Vela Operations Singapore Pte Ltd | ViroKey SARS-CoV-2 RT-PCR Test 08/05/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | ||
12/03/2021 | 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 | ||
12/28/2020 | Solaris Diagnostics | Solaris Multiplex SARS-CoV-2 Assay 08/10/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | ||
01/28/2021 | Alpha Genomix Laboratories | Alpha Genomix TaqPath SARS-CoV-2 Combo Assay 08/10/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | ||
06/22/2021 | Biomeme, Inc. | Biomeme SARS-CoV-2 Real-Time RT-PCR Test 08/11/2020 |
Real-time RT-PCR, Pooled Serial Screening - Swab, Pooled Serial Screening - Media | H | HCP, Patient, IFU | 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 | ||
05/28/2021 | Pro-Lab Diagnostics | Pro-AmpRT SARS-CoV-2 Test 08/13/2020 |
RT, Isothermal amplification | H | HCP, Patient, EUA Summary | None | ||
10/29/2021 | Yale School of Public Health, Department of Epidemiology of Microbial Diseases | SalivaDirect 08/15/2020 |
Real-time RT-PCR, Saliva, Home Collection, Screening, Pooling | 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 | ||
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 | ||
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 | ||
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 | ||
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 | ||
11/18/2021 | MiraDx | MiraDx SARS-CoV-2 RT-PCR assay 08/31/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | ||
07/07/2021 | Mammoth Biosciences, Inc. | SARS-CoV-2 DETECTR Reagent Kit 08/31/2020 |
RT-LAMP, CRISPR | H | HCP, Patients, IFU | 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 | ||
06/17/2021 | MobileDetect Bio Inc. | MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit 09/01/2020 |
RT-LAMP | H, M | HCP, Patients, IFU | None | ||
12/28/2020 | OPTOLANE Technologies, Inc. | Kaira 2019-nCoV Detection Kit 09/01/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | 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 | ||
05/24/2021 | Bioeksen R&D Technologies Inc. | Bio-Speedy Direct RT-qPCR SARS-CoV-2 09/02/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU |
|
||
10/20/2021 | 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 | ||
06/23/2021 | BillionToOne, Inc. | qSanger-COVID-19 Assay 09/04/2020 |
Sequencing | H | HCP, Patients, IFU | None | ||
11/08/2021 | 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 | ||
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 | ||
06/24/2021 | 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 | ||
08/31/2021 | Visby Medical, Inc. | Visby Medical COVID-19 09/16/2020 |
RT-PCR, Pooling | H, M | HCP, Patients, IFU | None | None | |
08/27/2021 | GK Pharmaceuticals Contract Manufacturing Operations | GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT 09/18/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | ||
07/15/2021 | KimForest Enterprise Co., Ltd. | KimForest SARS-CoV-2 Detection Kit v1 09/21/2020 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | ||
05/06/2021 | Quadrant Biosciences Inc. | Clarifi COVID-19 Test Kit 09/22/2020 |
Real-time RT-PCR, Saliva, Pooling | H | HCP, Patients, IFU | None | ||
07/08/2021 | 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 | ||
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 | ||
11/19/2021 | Aeon Global Health | Aeon Global Health SARS-CoV-2 Assay 09/30/2020 |
Real-time RT-PCR | H | HCP, Patients, EUA Summary | None | ||
08/13/2021 | CENTOGENE US, LLC | CentoSure SARS-CoV-2 RT-PCR Assay 09/29/2020 |
Real-time RT-PCR, Screening | H | HCP, Patients, EUA Summary | 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 | ||
04/02/2021 | 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 | ||
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 | ||
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 | ||
08/30/2021 | 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 | ||
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 | ||
07/28/2021 | 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 | |
08/04/2021 | Spectrum Solutions LLC | SDNA-1000 Saliva Collection Device 10/08/2020 |
Saliva Collection Device | N/A | EUA Summary, IFU | None | None | |
11/30/2021 | LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 RNA STAR Complete 10/14/2020 |
RT, qSTAR amplification, Home Collection, Screening, Pooling | H | HCP, Patients, IFU | None | ||
06/10/2021 | Clinical Enterprise, Inc. | EmpowerDX COVID-19 Home Collection Kit DTC 10/15/2020 |
Home Collection Kit, Direct to Consumer (DTC), Screening | N/A | EUA Summary, Individuals, IFU | None | None | |
06/23/2021 | Viracor Eurofins Clinical Diagnostics | Viracor SARS-CoV-2 assay 04/06/2020 |
Real-Time RT-PCR, Pooling, Screening, Pooled Serial Screening - Swab | H | HCP, Patients, EUA Summary | None | ||
08/13/2021 | binx health, Inc. | binx health At-Home Nasal Swab COVID-19 Sample Collection Kit 10/20/2020 |
Home Collection Kit | N/A | EUA Summary, IFU | None | ||
05/04/2021 | Agena Bioscience, Inc. | MassARRAY SARS-CoV-2 Panel 10/26/2020 |
RT-PCR, chip array and MALDI-TOF Mass Spec. | 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 | ||
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 | ||
11/23/2020 | RapidRona, Inc. | RapidRona Self-Collection Kit 11/23/2020 |
Home Collection Kit | N/A | EUA Summary, IFU (Collection) | None | ||
10/15/2021 | Gravity Diagnostics, LLC | Gravity Diagnostics SARS-CoV-2 RT-PCR Assay 11/23/2020 |
Real-time RT-PCR, Home Collection, Saliva, Screening | 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 | ||
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 | ||
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 | ||
11/17/2021 | 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 | ||
10/26/2021 | Hologic, Inc. | Aptima SARS-CoV-2/Flu assay 12/16/2020 |
Real-time TMA, chemiluminescent, Multi-analyte | H | HCP, Patients, IFU | 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 | ||
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 | ||
07/16/2021 | 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 | ||
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 | ||
06/24/2021 | Clinomics USA Inc. | Clinomics TrioDx RT-PCR COVID-19 Test 02/04/2021 |
Real-time RT-PCR | H | HCP, Patients, IFU | 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 | ||
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 | ||
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 | ||
08/03/2021 | 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 | ||
10/15/2021 | 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 | ||
09/07/2021 | 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 | |
07/01/2021 | 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 | |
08/26/2021 | University of Illinois Office of the Vice President for Economic Development and Innovation | covidSHIELD 02/24/2021 |
Real-time RT-PCR, Saliva, Serial Screening, Home Collection | H | HCP, Patients, EUA Summary IFU (Home Collect) | None | None | |
05/18/2021 | 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 | ||
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 | ||
07/01/2021 | Abbott Molecular Inc. | Alinity m Resp-4-Plex 03/04/2021 |
Real-time RT-PCR, Multi-analyte | H, M | HCP, Patients, IFU | 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 | ||
06/15/2021 | 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, Pooled Serial Screening - Swab | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | ||
05/26/2021 | 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 | |
09/3/2021 | 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 | |
09/03/2021 | Color Health, Inc. | Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC 03/19/2021 |
Direct to Consumer (DTC), RT, LAMP, Home Collection, Screening | H | EUA Summary, Individuals, HCP | None | None | |
06/25/2021 | Twist Bioscience Corporation | SARS-CoV-2 NGS Assay 03/23/2021 |
Sequencing | H | HCP, Patients, IFU | 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 | ||
05/28/2021 | 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 | ||
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 | ||
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 | ||
10/12/2021 | Thermo Fisher Scientific Inc. | Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit 04/09/2021 |
Real-time RT-PCR, Saliva | H | HCP, Patients, IFU | 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 | ||
06/24/2021 | Clinical Enterprise, Inc. | Clinical Enterprise SARS-CoV-2 RT-PCR Assay 04/13/2021 |
Real-time RT-PCR, Screening, Pooled Serial Screening - Swab | H | HCP, Patients, EUA Summary | None | ||
04/13/2021 | Clinical Enterprise, Inc. | Clinical Enterprise SARS-CoV-2 RT-PCR Assay DTC 04/13/2021 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening | H | HCP, Individuals, EUA Summary | 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 | ||
09/15/2021 | 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 | |
05/18/2021 | 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 | ||
06/02/2021 | Synergy Diagnostic Laboratory, Inc., DBA SynergyDx | SynergyDx SARS-CoV-2 RNA Test DTC 04/16/2021 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening | H | HCP, Individuals, EUA Summary, IFU (Home Collect) | None | ||
06/02/2021 | Synergy Diagnostic Laboratory, Inc., DBA SynergyDx | SynergyDx SARS-CoV-2 RNA Test 04/16/2021 |
Real-time RT-PCR, Home Collection, Screening | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | ||
09/22/2021 | 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 | |
07/22/2021 | PathogenDx, Inc. | DetectX-Rv 04/20/2021 |
RT-PCR, DNA Microarray Hybridization | H | HCP, Patients, IFU | None | None | |
05/17/2021 | Phosphorus Diagnostics LLC | Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC 05/17/2021 |
Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening | N/A | Individual, EUA Summary, IFU | None | None | |
05/17/2021 | Phosphorus Diagnostics LLC | Phosphorous COVID19 RT-qPCR Test DTC 05/17/2021 |
Real-time RT-PCR, Direct to Consumer (DTC), Screening, Salvia, Home Collection | H | HCP, Individuals, EUA Summary | None | ||
07/08/2021 | Harvard University Clinical Laboratory (HUCL) | Quaeris SARS-CoV-2 Assay 05/21/2021 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None | |
05/25/2021 | Thermo Fisher Scientific Inc. | TaqPath COVID-19 Pooling Kit 05/25/2021 |
Real-time RT-PCR, Pooling | H | HCP, Patients, IFU | None | ||
08/09/2021 | STS Lab Holdco (a subsidiary of Amazon.com Services LLC) | Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 05/28/2021 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening | H | HCP, Individuals, EUA Summary, IFU, FAQ | None | None | |
06/17/2021 | WREN Laboratories LLC | WREN Laboratories COVID-19 PCR Test DTC 06/17/2021 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Saliva Screening | H | HCP, Individuals, EUA Summary | None | ||
06/17/2021 | WREN Laboratories LLC | WREN Laboratories COVID-19 Saliva Test Collection Kit DTC 06/17/2021 |
Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening | N/A | Individuals, EUA Summary, IFU | None | None | |
06/17/2021 | Roche Molecular Systems | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) 06/17/2021 |
Real-time RT-PCR, Screening | H, M, W | HCP, Patients, IFU | None | ||
06/29/2021 | BioGX, Inc. | BioGX Xfree COVID-19 Direct RT-PCR 06/29/2021 |
Real-time RT-PCR | H | HCP, Patients, IFU | None | ||
07/14/2021 | Exact Sciences Laboratories | COVID-Flu Multiplex Assay 07/01/2021 |
Real-time RT-PCR, Multi-analyte, Home Collection | H | None | |||
07/01/2021 | Everlywell, Inc. | Everlywell COVID-19 & Flu Test Home Collection Kit 07/01/2021 |
Home Collection Kit, Multi-analyte | N/A | IFU, EUA Summary | None | None | |
09/01/2021 | Thermo Fisher Scientific Inc. | TaqPath COVID-19 RNase P Combo Kit 2.0 07/08/2021 |
Real-time RT-PCR, Serial Screening, Home Collection | H | HCP, Patients, IFU | None | None | |
10/22/2021 | Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.) | TaqPath COVID-19 Fast PCR Combo Kit 2.0 07/30/2021 |
Real-time RT-PCR, Saliva | H | HCP, Patients, IFU | None | ||
11/29/2021 | Kwokman Diagnostics, LLC | Kwokman Diagnostics COVID-19 Home Collection Kit 08/13/2021 |
Home Collection Kit | N/A | IFU, EUA Summary | None | None | |
09/22/2021 | Life Sciences Testing Center | Life Sciences Testing Center COVID-19 Test 09/22/2021 |
Real-time RT-PCR, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None | |
10/14/2021 | LMSI, LLC (dba Lighthouse Lab Services) | CovidNow SARS-CoV-2 Assay 10/14/2021 |
Real-time RT-PCR, Home Collection, Screening | H | HCP, Patients, IFU, IFU (Home Collect) | None | None | |
11/30/2021 | Audere | HealthPulse@home 11/30/2021 |
Home Collection Kit, Screening | N/A | EUA Summary, 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;
Revision Concerning Viral Mutations
On September 23, 2021, the FDA revised the EUAs of certain molecular, antigen, and serology tests to establish additional Conditions of Authorization in response to the continued emergence of new variants of SARS-CoV-2. The revision requires test developers to update their authorized labeling and evaluate the impact of SARS-CoV-2 viral mutations on their test’s performance as outlined in the letter. This revision is effective as of September 23, 2021 for all EUAs that are within the scope of the revision. This revision does not apply to EUAs for authorized IL-6 assays or standalone specimen collection devices and does not apply to EUAs that include substantially equivalent viral mutation conditions of authorization.
The FDA has determined that establishing additional conditions is necessary to mitigate the potential risk of false negative results due to either decreased sensitivity or non-reactivity associated with SARS-CoV-2 viral mutations. As set forth in the September 23, 2021 letter, developers of authorized tests that are within the scope of the revision are now required to routinely monitor emerging viral mutations and their potential impact on the performance of the authorized SARS-CoV-2 test(s). If potential impacts are identified, the EUA holder must communicate with the FDA and end users about the potential risk that presence of the mutations may have on test performance. The EUA holder must also update their authorized labeling consistent with the revision letter and submit the labeling to the FDA within 3 months of September 23, 2021. By taking these steps, the FDA and the test developer can quickly act in response to the potential risks identified and, when applicable, share the findings on SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.
Viral Mutation Revision Letter – September 23, 2021
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
The table below includes information for the authorized RT-PCR molecular diagnostic tests for SARS-CoV-2 amended by this Pooling and Serial Testing Amendment. For authorization documents for each test, see Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2 above.
Date Added to Exhibit 1 | EUA Holder | Test Name | Indication(s)* |
---|---|---|---|
06/24/2021 | Clinical Enterprise, Inc. | Clinical Enterprise SARS-SoV-2-RT-PCR Assay | Swab: Up to 10 (Appendix C) |
06/15/2021 | 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) | Swab: Up to 10 (Appendix C) |
06/22/2021 | Biomeme, Inc. | Biomeme SARS-CoV-2 Real-Time RT-PCR Test | Swab: Up to 10 (Appendix C) Media: Up to 5 (Appendix G) |
06/23/2021 | Viracor Eurofins Clinical Diagnostics | Viracor SARS-CoV-2 assay | Swab: Up to 10 (Appendix C) |
* The indications in each appendix (A-H) differ in the number of specimens that can be pooled (up to 3, up to 5, or up to 10) and the type of pooling that can be done (media or swab pooling).
Tests authorized for Swab Pooling are authorized for:
- Qualitative detection of RNA from SARS-CoV-2 in pooled samples containing up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swabs placed in a single vial containing transport media after being collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from any individual, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week as part of a serial testing program.
This indication is authorized for use in laboratories certified under CLIA to perform high complexity tests except tests authorized for use in specific named or designated laboratories can only be used in such laboratories.
Tests authorized for Media Pooling are authorized for:
- Qualitative detection of RNA from SARS-CoV-2 in pooled samples containing aliquots of transport media from up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swab specimens that were collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from any individual and placed in individual vials containing transport media, including individuals without symptoms or other reasons to suspect COVID-19, when tested as part of a serial testing program including testing at least once per week.
This indication is authorized for use in laboratories certified under CLIA to perform high complexity tests except tests authorized for use in specific named or designated laboratories can only be used in such laboratories.
Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing
On November 15, 2021, the FDA issued an umbrella EUA for certain RT-PCR molecular-based tests, developed by laboratories, for detection of nucleic acid from SARS-CoV-2 from anterior nasal respiratory specimens for use as part of a serial testing program, that meet certain criteria for eligibility specified in the EUA. Under this EUA, authorized tests can be used with individual or pooled anterior nasal specimens for testing individuals, including individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least once per week. This means that tests authorized by this EUA may be used with individual or pooled anterior nasal respiratory specimens from individuals with or without known or suspected exposure to COVID-19 when such individuals are tested at least once per week, such as testing at regular intervals as part of a testing program implemented by schools, workplaces, or community groups. The indications in each appendix (A-K) differ in the number of specimens that can be pooled (1, up to 3, up to 5, or up to 10), the type of pooling that can be done (media pooling or swab pooling), and whether the test can be used with home collected specimens.
Use of tests authorized by this EUA is limited to use in the single laboratory that developed the authorized test and that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets requirements to perform high complexity tests.
Tests will be added to Exhibit 1 of this EUA following submission of a complete notification to the FDA with the information required by the EUA, including self-certifying that the applicable validation has been completed, and confirmation by the FDA that the required documentation has been submitted. Being added to Exhibit 1 does not necessarily mean that the FDA has reviewed the underlying validation data submitted or confirmed that the test is appropriately validated.
- EUA Letter of Authorization - Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing
- Appendix L - Fact Sheet for Health Care Providers (Template)
- Appendix M - Fact Sheet for Patients (Template)
- Appendix N - Test Summary (Template)
Exhibit 1 of the Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing
This exhibit will include information for the RT-PCR molecular diagnostic tests for SARS-CoV-2 authorized by this umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing.
EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests
On March 31, 2020, the FDA issued an umbrella EUA for molecular laboratory developed tests (LDTs) for detection of SARS-CoV-2 that meet certain criteria for eligibility described in the EUA. Under this EUA, authorized tests are authorized for use in the single laboratory that developed the authorized test and that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests. Tests authorized under this umbrella EUA were added to Appendix A in the table below.
On November 15, 2021, the FDA reissued this EUA such that only tests that are listed in Appendix A are authorized for use as described in the EUA, and no additional tests will be authorized by this EUA. The reissued EUA also includes updated Conditions of Authorization and Fact Sheets to reflect the most up-to-date information.
- 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 list of tests authorized under this EUA
Appendix A: Authorized Molecular-Based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2
The table below includes information for the high complexity molecular-based laboratory developed SARS-CoV-2 assays authorized by this EUA during the COVID-19 public health emergency.
To see additional authorization documents, such as letters granting EUA amendments or revisions, for a specific test, select the plus (+) button beside the “Date Last Updated” for each test.
All authorized devices in the table below are assigned the QJR product code.
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.