2-Day Online Rapid Microbiological Methods Master Class - July 15-16, 2020

Last month we held a very exciting online training program for rapid methods. To accommodate additional requests to repeat the training, the next online 2-Day Rapid Microbiological Methods Master Class will be held on July 15-16, 2020, from 1000 - 1430 EDT. This will be a live event where you will learn about the current regulatory policies for validation and submissions, the scientific principles for commercially-available rapid technologies, a comprehensive,step-by-step guide for validation including the use of statistical models, case studies on rapid sterility testing for ATMPs (cell therapy) and real-time environmental monitoring, and how to develop a financial justification when purchasing a RMM system. For the complete agenda and information on how to register, please visit http://rapidmicromethods.com/events/masterclass-july2020.php.

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

As of September 2, 2021, there are 386 in vitro diagnostic EUAs (260 molecular/collection, 34 antigen, 88 serology, 4 COVID-19 management IVD) and 82 validated serology or serum / plasma / whole blood tests that have not received an EUA. 

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

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

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

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

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

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

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

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

Date of EUA Original Issue	Entity	Letter of Authorization	Attributes3	Authorized Settings1	Authorization Documents2
08/27/2021	Yale School of Public Health, Department of Epidemiology of Microbial Diseases	SalivaDirect for use with DTC Kits	Direct to Consumer (DTC), Real-time RT-PCR, Saliva, Home Collection, Screening	H	HCP Individuals EUA Summary
08/27/2021	Yale School of Public Health, Department of Epidemiology of Microbial Diseases	SalivaDirect DTC Saliva Collection Kit	Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening	N/A	Individual IFU-1 IFU-2 EUA Summary
08/25/2021	Empire City Laboratories	ECL COVID TEST SYSTEM-1	Real-time RT-PCR, Home Collection	H	HCP Patients EUA Summary IFU (Home Collect)
08/25/2021	Empire City Laboratories	ECL COVID TEST SYSTEM	Real-time RT-PCR, Home Collection	H	HCP Patients EUA Summary IFU (Home Collect)
08/25/2021	QIAGEN GmbH	QIAreach SARS-CoV-2 Antigen	Digital Lateral Flow, Fluorescence, Instrument Read	H, M	HCP Patients IFU
08/24/2021	InBios International, Inc.	SCoV-2 Detect IgG Rapid Test	IgG, Lateral Flow, Fingerstick Whole Blood	H, M, W	HCP Recipients IFU
08/24/2021	Becton, Dickinson and Company (BD)	BD Veritor At-Home COVID-19 Test	Lateral Flow, Digital Read, Over the Counter (OTC) Home Testing, Serial Screening	H, M, W	HCP Individuals IFU IFU (Home Test)
08/23/2021	The Mount Sinai Hospital, Center for Clinical Laboratories	Mount Sinai SARS-CoV-2 Assay	Real-time RT-PCR, Home Collection, Saliva, Screening	H	HCP Patients EUA Summary IFU (Home Collect)
08/13/2021	Kwokman Diagnostics, LLC	Kwokman Diagnostics COVID-19 Home Collection Kit	Home Collection Kit	N/A	IFU EUA Summary
08/11/2021	STS Lab Holdco (a subsidiary of Amazon.com Services LLC)	Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test	Real-time RT-PCR, Home Collection, Pooling, Screening	H	HCP Patients EUA Summary IFU (Home Collect)
08/11/2021	STS Lab Holdco (a subsidiary of Amazon.com Services LLC)	Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening	H	HCP Individuals EUA Summary IFU (Home Collect) FAQ
08/09/2021	Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute	SelfCheck COVID-19 TaqPath Multiplex PCR	Real-time RT-PCR, Home Collection	H	HCP Patients EUA Summary IFU (Home Collect)
08/02/2021	Access Bio, Inc.	CareStart COVID-19 Antigen Home Test	Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening	Home, H, M, W	HCP Individuals IFU IFU (Home Test)
08/02/2021	LumiraDx UK Ltd.	LumiraDx SARS-CoV-2 Ab Test	Total Antibody, Fluorescence Immunoassay, Fingerstick Whole Blood	H, M, W	HCP Recipients IFU
08/02/2021	Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.)	TaqPath COVID-19 MS2 Combo Kit 2.0	Real-time RT-PCR	H	HCP Patients IFU
07/30/2021	Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.)	TaqPath COVID-19 Fast PCR Combo Kit 2.0	Real-time RT-PCR, Saliva	H	HCP Patients IFU
07/28/2021	PHASE Scientific International, Ltd.	INDICAID COVID-19 Rapid Antigen Test	Lateral Flow, Visual Read	H, M, W	HCP Patients IFU
07/22/2021	Ortho-Clinical Diagnostics, Inc.	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators	Total Antibody, CLIA	H, M	HCP Recipients IFU
07/22/2021	Becton, Dickinson and Company	BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site)	Blood Collection Tube	Home, H, M	HCP and Authorized Laboratories
07/13/2021	GenBody Inc.	GenBody COVID-19 Ag	Lateral Flow, Visual Read	H, M, W	HCP Patients IFU
07/09/2021	Ortho-Clinical Diagnostics, Inc.	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator	IgG, CLIA, Quantitative	H, M	HCP Recipients IFU
07/08/2021	Ellume Limited	ellume.lab COVID Antigen Test	Lateral Flow, Fluorescence, Instrument Read	H, M, W	HCP Patients IFU
07/01/2021	Bio-Rad Laboratories	BioPlex 2200 SARS-CoV-2 IgG	IgG, Bead-based Fluorescent Immunoassay, Semi-quantitative	H, M	HCP Recipients IFU
07/01/2021	Exact Sciences Laboratories	COVID-Flu Multiplex Assay	Real-time RT-PCR, Multi-analyte, Home Collection	H	HCP Patients EUA Summary IFU (Home Collect)
07/08/2021	Thermo Fisher Scientific Inc.	TaqPath COVID-19 RNase P Combo Kit 2.0	Real-time RT-PCR, Serial Screening	H	HCP Patients IFU
07/01/2021	Everlywell, Inc.	Everlywell COVID-19 & Flu Test Home Collection Kit	Home Collection Kit, Multi-analyte	N/A	IFU EUA Summary
06/29/2021	BioGX, Inc.	BioGX Xfree COVID-19 Direct RT-PCR	Real-time RT-PCR	H	HCP Patients IFU
06/17/2021	Siemens Healthcare Diagnostics Inc.	ADVIA Centaur SARS-CoV-2 IgG (sCOVG)	IgG, CLIA, Semi-quantitative	H, M	HCP Recipients IFU
06/17/2021	WREN Laboratories LLC	WREN Laboratories COVID-19 Saliva Test Collection Kit DTC	Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening	N/A	Individuals EUA Summary IFU
06/17/2021	WREN Laboratories LLC	WREN Laboratories COVID-19 PCR Test DTC	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Saliva Screening	H	HCP Individuals EUA Summary
06/17/2021	Roche Molecular Systems	cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2)	Real-time RT-PCR, Screening	H, M, W	HCP Patients IFU
06/04/2021	Diabetomics, Inc.	CovAb SARS-CoV-2 Ab Test	Total Antibody, Lateral Flow, Oral Fluid	H, M, W	HCP Recipients IFU
06/04/2021	OraSure Technologies, Inc.	InteliSwab COVID-19 Rapid Test Rx	Lateral Flow, Visual Read, Prescription Home Testing	Home, H, M, W	HCP IFU IFU (Home Test)
06/04/2021	OraSure Technologies, Inc.	InteliSwab COVID-19 Rapid Test	Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening	Home, H, M, W	HCP Individuals IFU IFU (Home Test)
06/04/2021	OraSure Technologies, Inc.	InteliSwab COVID-19 Rapid Test Pro	Lateral Flow, Visual Read, Serial Screening	H, M, W	HCP Patients IFU
05/29/2021	Siemens Healthcare Diagnostics Inc.	Atellica IM SARS-CoV-2 Total (COV2T)	Total Antibody, CLIA	H, M	HCP Recipients IFU
05/28/2021	STS Lab Holdco (a subsidiary of Amazon.com Services LLC)	Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening	H	HCP Individuals EUA Summary IFU FAQ
05/25/2021	Thermo Fisher Scientific Inc.	TaqPath COVID-19 Pooling Kit	Real-time RT-PCR, Pooling	H	HCP Patients IFU
05/21/2021	Harvard University Clinical Laboratory (HUCL)	Quaeris SARS-CoV-2 Assay	Real-time RT-PCR, Home Collection	H	HCP Patients EUA Summary IFU (Home Collect)
05/20/2021	Salofa Oy	Sienna-Clarity COVID-19 Antigen Rapid Test Cassette	Lateral Flow, Visual Read	H, M, W	HCP Patients IFU
05/19/2021	DiaSorin, Inc.	LIAISON SARS-CoV-2 TrimericS IgG	IgG, CLIA, Semi-quantitative	H, M	HCP Recipients IFU
05/17/2021	Phosphorus Diagnostics LLC	Phosphorous COVID19 RT-qPCR Test DTC	Real-time RT-PCR, Direct to Consumer (DTC), Screening, Salvia	H	HCP Individuals EUA Summary
05/17/2021	Phosphorus Diagnostics LLC	Pinpoint by Phosphorus COVID-19 Test Home Collection Kit	Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening	N/A	Individual EUA Summary IFU
05/15/2021	Fulgent Therapeutics	Fulgent COVID-19 by RT-PCR Test	Real-time RT-PCR, Home Collection, Screening	H	HCP Patients EUA Summary IFU (Home Collect)
05/11/2021	ZEUS Scientific, Inc.	ZEUS ELISA SARS-CoV-2 Total Antibody Test System	Total Antibody, ELISA	H, M	HCP Recipients IFU
05/11/2021	QIAGEN, GmbH	QIAreach Anti-SARS-CoV-2 Total Test	Total Antibody, Digital Lateral Flow	H, M	HCP Recipients IFU
05/06/2021	InBios International, Inc.	SCoV-2 Ag Detect Rapid Test	Lateral Flow, Visual Read, Serial Screening	H, M, W	HCP Patients IFU
04/20/2021	PathogenDx, Inc.	DetectX-Rv	RT-PCR, DNA Microarray Hybridization	H	HCP Patients IFU
04/19/2021	Inova Diagnostics, Inc.	QUANTA Flash SARS-CoV-2 IgG	IgG, CLIA, Semi-quantitative	H, M	HCP Recipients IFU
04/19/2021	Southern California Permanente Medical Group	Kaiser Permanente High Throughput SARS-CoV-2 Assay	Real-Time RT-PCR, Saliva, Home Collection	H	HCP Patients EUA Summary IFU (Home Collect)
04/16/2021	Synergy Diagnostic Laboratory, Inc., DBA SynergyDx	SynergyDx SARS-CoV-2 RNA Test DTC	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	H	HCP Individuals EUA Summary IFU (Home Collect)
04/16/2021	Celltrion USA, Inc.	Celltrion DiaTrust COVID-19 Ag Rapid Test	Lateral Flow, Visual Read, Serial Screening	H, M, W	HCP Patients IFU
04/16/2021	Synergy Diagnostic Laboratory, Inc., DBA SynergyDx	SynergyDx SARS-CoV-2 RNA Test	Real-time RT-PCR, Home Collection, Screening	H	HCP Patients EUA Summary IFU (Home Collect)
04/15/2021	LGC, Biosearch Technologies	Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test	Real-Time and End-Point RT-PCR	H	HCP Patients IFU
04/14/2021	Color Health, Inc.	Color SARS-CoV-2 RT-LAMP Diagnostic Assay	RT, LAMP, Home Collection, Screening	H	HCP Patients EUA Summary
04/13/2021	Qorvo Biotechnologies, LLC.	Omnia SARS-CoV-2 Antigen Test	Bulk Acoustic Wave (BAW) Biosensor, Instrument Read	H, M	HCP Patients IFU
04/13/2021	Clinical Enterprise, Inc.	Clinical Enterprise SARS-CoV-2 RT-PCR Assay	Real-time RT-PCR, Screening	H	HCP Patients EUA Summary
04/13/2021	Clinical Enterprise, Inc.	Clinical Enterprise SARS-CoV-2 RT-PCR Assay DTC	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	H	HCP Individuals EUA Summary
04/12/2021	PerkinElmer Genomics	PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit	Real-time RT-PCR, Home Collection	H	HCP Patients EUA Summary
04/09/2021	Lucira Health, Inc.	Lucira CHECK-IT COVID-19 Test Kit	RT, LAMP, Over the Counter (OTC) Home Testing, Screening	Home, H, M, W	HCP IFU IFU (Home Test)
04/09/2021	Thermo Fisher Scientific	Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit	Real-time RT-PCR	H	HCP Patients IFU
04/09/2021	Yale School of Public Health, Department of Epidemiology of Microbial Diseases	SalivaDirect At-Home Collection Kit	Home Collection Kit, Saliva, Screening	H	EUA Summary IFU
04/05/2021	Symbiotica, Inc.	COVID-19 Self-Collected Antibody Test System	ELISA, Home Collection, Fingerstick Dried Blood Spot	Home, H	HCP Recipients EUA Summary IFU (Home Collect)
03/31/2021	Abbott Diagnostics Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening	Home, H, M, W	HCP Individuals IFU IFU (Home Test)
03/31/2021	Abbott Diagnostics Scarborough, Inc.	BinaxNOW COVID-19 Ag 2 Card	Lateral Flow, Visual Read, Non-prescription Testing, Serial Screening	H, M, W	HCP Patients IFU
03/31/2021	Abbott Diagnostics Scarborough, Inc.	BinaxNOW COVID-19 Ag Card 2 Home Test	Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Telehealth Proctor Supervised, Serial Screening	Home, H, M, W	HCP Individuals IFU IFU (Home Test)
03/31/2021	Quidel Corporation	QuickVue At-Home OTC COVID-19 Test	Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening	Home, H, M, W	HCP Individuals IFU IFU (Home Test)
03/26/2021	DiaSorin, Inc.	LIAISON SARS-CoV-2 Ag	CLIA	H, M	HCP Patients IFU
03/25/2021	NeuMoDx Molecular, Inc.	NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay	Real-time RT-PCR, Multi-analyte	H, M	HCP Patients IFU
03/25/2021	STS Lab Holdco (a subsidiary of Amazon.com Services LLC)	Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2	Real-time RT-PCR, Home Collection, Screening	H	HCP Patients EUA Summary
03/24/2021	Becton, Dickinson and Company (BD)	BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B	Chromatographic Digital Immunoassay, Instrument Read, Multi-analyte	H, M, W	HCP Patients IFU
03/23/2021	Twist Bioscience Corporation	SARS-CoV-2 NGS Assay	Sequencing	H	HCP Patients IFU
03/23/2021	Siemens Healthcare Diagnostics Inc.	Atellica IM SARS-CoV-2 IgG (sCOVG)	IgG, CLIA, Semi-quantitative	H, M	HCP Recipients IFU
03/22/2021	Beckman Coulter, Inc.	Access SARS-CoV-2 IgG II	IgG, CLIA, Semi-quantitative	H, M	HCP Recipients IFU
03/19/2021	Color Health, Inc.	Color COVID-19 Self-Swab Collection Kit DTC	Home Collection Kit, Direct to Consumer (DTC), Screening	N/A	EUA Summary Individuals IFU
03/19/2021	Color Health, Inc.	Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC	Direct to Consumer (DTC), RT, LAMP, Home Collection, Screening	H	EUA Summary Individuals HCP
03/09/2021	GetMyDNA	GetMyDNA COVID-19 Test Home Collection Kit	Home Collection Kit, Direct to Consumer (DTC), Screening	N/A	EUA Summary Individuals IFU
03/05/2021	Cue Health Inc.	Cue COVID-19 Test for Home and Over The Counter (OTC) Use	RT, Isothermal amplification Over the Counter (OTC) Home Testing, Screening	Home, H, M, W	HCP Individuals IFU IFU (Home Test) FAQ
03/05/2021	Adaptive Biotechnologies Corporation	T-Detect COVID Test	T-cell receptor beta (TCR β), Sequencing	H	HCP Recipients EUA Summary
03/05/2021	Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard	CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3)	Real-time RT-PCR, Home Collection	H	HCP Patients EUA Summary IFU (Home Collect)
03/04/2021	Abbott Molecular Inc.	Alinity m Resp-4-Plex	Real-time RT-PCR, Multi-analyte	H, M	HCP Patients IFU
03/03/2021	Luminex Molecular Diagnostics, Inc.	NxTAG Respiratory Pathogen Panel + SARS-CoV-2	RT-PCR, Multi-analyte	H	HCP Patients IFU
03/01/2021	Abbott Laboratories Inc.	AdviseDx SARS-CoV-2 IgG II	IgG, CMIA, Semi-quantitative	H, M	HCP Recipients IFU-ARCHITECT IFU-Alinityi
03/01/2021	Quidel Corporation	QuickVue At-Home COVID-19 Test	Lateral Flow, Visual Read, Prescription Home Testing	Home, H, W, W	HCP Patients IFU IFU (Home Test)
02/26/2021	Viracor Eurofins Clinical Diagnostics	Viracor SARS-CoV-2 Assay DTC	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	H	HCP Patients EUA Summary
02/24/2021	University of Illinois Office of the Vice President for Economic Development and Innovation	covidSHIELD	Real-time RT-PCR, Saliva	H	HCP Patients EUA Summary
02/13/2021	Gravity Diagnostics, LLC	Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC Kits	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	H	HCP Individuals EUA Summary
02/13/2021	Assurance Scientific Laboratories	Assurance SARS-CoV-2 Panel DTC	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	H	HCP Individuals EUA Summary IFU (Home Collect)
02/13/2021	Everlywell, Inc.	Everlywell COVID-19 Test Home Collection Kit DTC	Home Collection Kit, Direct to Consumer (DTC), Screening	N/A	Individuals EUA Summary IFU (Home Collect)
02/11/2021	Bio-Rad Laboratories, Inc.	Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit	Real-time RT-PCR, Multi-analyte	H	HCP Patients IFU
02/10/2021	Immunodiagnostic Systems Ltd.	IDS SARS-CoV-2 IgG	IgG, CLIA	H, M	HCP Recipients IFU
02/10/2021	Becton, Dickinson and Company (BD)	BD SARS-CoV-2/Flu for BD MAX System	Real-time RT-PCR, Multi-analyte	H, M	HCP Patients IFU
02/10/2021	Thermo Fisher Scientific	TaqPath COVID-19, FluA, FluB Combo Kit	Real-time RT-PCR, Multi-analyte	H	HCP Patients IFU
02/10/2021	Grifols Diagnostic Solutions Inc.	Procleix SARS-CoV-2 Assay	TMA	H	HCP Patients IFU
02/08/2021	Visby Medical, Inc.	Visby Medical COVID-19 Point of Care Test	RT-PCR	H, M, W	HCP Patients IFU IFU (Collect)
02/04/2021	Princeton BioMeditech Corp.	Status COVID-19/Flu	Lateral Flow, Visual Read, Multi-analyte	H, M, W	HCP Patients IFU
02/04/2021	Clinomics USA Inc.	Clinomics TrioDx RT-PCR COVID-19 Test	Real-time RT-PCR	H	HCP Patients IFU
01/22/2021	Ambry Genetics Laboratory	Ambry COVID-19 RT-PCR Test	Real-time RT-PCR, Home Collection, Saliva	H	HCP Patients IFU (Home Collect) EUA Summary
01/19/2021	Hospital of the University of Pennsylvania	BD MAX COVID-19 ASSAY (Authorized by HHS/OASH)	Real-time RT-PCR	H	HCP Patients EUA Summary
01/19/2021	INNO Diagnostics Reference Laboratory, Ponce Medical School	PMSF-INNO SARS-CoV-2 RT-PCR Test (Authorized by HHS/OASH)	Real-time RT-PCR	H	HCP Patients EUA Summary
01/15/2021	United Biomedical, Inc.	UBI SARS-CoV-2 ELISA	IgG, ELISA	H	HCP Recipients IFU
01/15/2021	Bio-Rad Laboratories, Inc.	Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit	Real-time RT-PCR	H	HCP Patients IFU
01/14/2021	SML GENETREE Co., Ltd.	Ezplex SARS-CoV-2 G Kit	Real-time RT-PCR, Pooling	H	HCP Patients IFU
01/11/2021	Phadia AB	EliA SARS-CoV-2-Sp1 IgG Test	IgG, Fluoro-enzyme Immuno-assay, Semi-quantitative	H, M	HCP Recipients IFU
01/11/2021	ADVAITE, Inc.	RapCov Rapid COVID-19 Test	IgG, Lateral Flow, Fingerstick Whole Blood	H, M, W	HCP Recipients IFU
01/11/2021	Ortho Clinical Diagnostics, Inc.	VITROS Immuno-diagnostic Products SARS-CoV-2 Antigen Reagent Pack	Chemilumin-escence Immuno-assay, Instrument Read	H, M	HCP Patients IFU
01/08/2021	Siemens Healthcare Diagnostics Inc.	Dimension EXL SARS‑CoV‑2 IgG (CV2G)	IgG, CLIA, Semi-quantitative	H, M, W	HCP Recipients IFU
01/08/2021	Siemens Healthcare Diagnostics Inc.	Dimension Vista SARS‑CoV‑2 IgG (COV2G)	IgG, CLIA, Semi-quantitative	H, M, W	HCP Recipients IFU
01/05/2021	Quanterix Corporation	Simoa SARS-CoV-2 N Protein Antigen Test	Para-magnetic Microbead-based Immuno-assay	H, M	HCP Patients IFU
12/31/2020	Nirmidas Biotech, Inc.	MidaSpot COVID-19 Antibody Combo Detection Kit	IgM and IgG, lateral flow	H, M, W	HCP Recipients IFU
12/23/2020	Cepheid	Xpert Xpress SARS-CoV-2 DoD	Real-time RT-PCR, Pooling	H, M, W	HCP Patients EUA Summary
12/23/2020	Quanterix Corporation	Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test	IgG, Para-magnetic Microbead-based Sandwich ELISA, Semi-quantitative	H, M	HCP Recipients IFU
12/23/2020	Quidel Corporation	Solana SARS-CoV-2 Assay	Isothermal Reverse Tran-scriptase – Helicase-Dependent Amplification (RT-HDA)	H, M	HCP Patients IFU
12/18/2020	Quidel Corporation	QuickVue SARS Antigen Test	Lateral Flow, Visual Read	H, M, W	HCP Patients IFU
12/18/2020	Siemens Healthcare Diagnostics Inc.	ADVIA Centaur IL6 Assay	One-step Direct Chemilumin-escent Immuno-assay	H, M	HCP Patients IFU
12/17/2020	Materials and Machines Corporation of America (DBA MatmaCorp, Inc.)	MatMaCorp COVID-19 2SF Test	RT-PCR and isothermal nucleic acid amplification	H	HCP Patients IFU
12/17/2020	Hologic, Inc.	Aptima SARS-CoV-2/Flu Assay	Real-time TMA, Chemilumin-escent, Multi-analyte	H	HCP Patients IFU
12/16/2020	Abbott Diagnostics Scarborough, Inc.	BinaxNOW COVID-19 Ag Card Home Test	Lateral Flow, Visual Read, Prescription Home Testing		HCP IFU IFU (Home Test)
12/15/2020	ACON Laboratories, Inc.	ACON SARS-CoV-2 IgG/IgM Rapid Test	IgM and IgG, Lateral Flow	H, M	HCP Recipients IFU
12/15/2020	Ellume Limited	Ellume COVID-19 Home Test	Lateral Flow, Fluore-scence, Instrument Read, Over the Counter		HCP IFU IFU (Home Test)
12/15/2020	RCA Laboratory Services LLC dba GENETWORx	GENETWORx Covid-19 Nasal Swab Test	Real-time RT-PCR, Home Collection	H	HCP Patients EUA Summary IFU (Home Collect)
12/11/2020	ResearchDx, Inc., DBA Pacific Diagnostics	PacificDx Covid-19	TMA, Chemilumin-escent, Home Collection	H	HCP Patients EUA Summary
12/09/2020	Laboratory Corporation of America (LabCorp)	Pixel by LabCorp COVID-19 Test Home Collection Kit	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening	H	HCP Individuals EUA Summary IFU (Home Collect)
12/07/2020	Luminostics, Inc.	Clip COVID Rapid Antigen Test	Lateral flow immuno-luminescent assay, instrument read	H, M, W	HCP Patients IFU
12/04/2020	Quest Diagnostics Infectious Disease, Inc.	Quest Diagnostics RC COVID-19+Flu RT-PCR	Real-time RT-PCR, Multi-analyte, Home Collection	H	HCP Patients EUA Summary IFU (Home Collection)
11/27/2020	Cepheid	Xpert Omni SARS-CoV-2	Real-time RT-PCR	H, M	HCP Patients IFU
11/25/2020	Roche Diagnostics, Inc.	Elecsys Anti-SARS-CoV-2 S	Total Antibody, ECLIA, Semi-quantitative	H, M	HCP Recipients IFU
11/24/2020	Kantaro Biosciences, LLC	COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit	IgG, ELISA, Semi-quantitative	H	HCP Recipients IFU
11/23/2020	Innovita (Tangshan) Biological Technology Co., Ltd.	Innovita 2019-nCoV Ab Test (Colloidal Gold)	IgM and IgG, Lateral Flow	H, M	HCP Recipients IFU
11/23/2020	RapidRona, Inc.	RapidRona Self-Collection Kit	Home Collection Kit	N/A	EUA Summary IFU (Collection)
11/23/2020	Gravity Diagnostics, LLC	Gravity Diagnostics SARS-CoV-2 RT-PCR Assay	Real-time RT-PCR, Home Collection, Screening, Saliva	H	HCP Patients EUA Summary
11/17/2020	Lucira Health, Inc.	Lucira COVID-19 All-In-One Test Kit	Prescription Home Testing	W	HCP IFU IFU (Home Test)
11/06/2020	GenScript USA Inc.	cPass SARS-CoV-2 Neutralization Antibody Detection Kit	Total Neutralizing Antibodies, Blocking ELISA	H	HCP Recipients IFU
10/28/2020	Quansys Biosciences, Inc.	Q-Plex SARS-CoV-2 Human IgG (4 Plex)	IgG, CLIA	H	HCP Recipients IFU
10/28/2020	DNA Genotek Inc.	ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100 saliva collection devices	Saliva Collection Device	N/A	EUA Summary IFU
10/26/2020	Agena Bioscience, Inc.	MassARRAY SARS-CoV-2 Panel	RT-PCR, chip array and MALDI-TOF Mass Spec.	H	HCP Patients IFU
10/23/2020	Celltrion USA, Inc.	Sampinute COVID-19 Antigen MIA	Magnetic Force-assisted Electrochemical Sandwich Immunoassay (MESIA)	H, M	HCP Patients IFU
10/20/2020	binx health, Inc.	binx health At-Home Nasal Swab COVID-19 Sample Collection Kit	Home Collection Kit	N/A	EUA Summary IFU
10/15/2020	Clinical Enterprise, Inc.	EmpowerDX At-Home COVID-19 PCR Test Kit	Home Collection Kit	N/A	EUA Summary IFU
10/14/2020	DNA Genotek Inc.	OMNIgene·ORAL OM-505 and OME-505 (OMNIgene·ORAL) saliva collection devices	Saliva Collection Device	N/A	EUA Summary IFU
10/14/2020	LumiraDx UK Ltd.	LumiraDx SARS-CoV-2 RNA STAR Complete	RT, qSTAR amplification	H	HCP Patients IFU
10/09/2020	Abbott Laboratories Inc.	AdviseDx SARS-CoV-2 IgM	IgM, CMIA	H, M	HCP Recipients IFU-ARCHITECT IFU-Alinityi
10/08/2020	Access Bio, Inc.	CareStart COVID-19 Antigen Test	Lateral Flow, Visual Read	H, M, W	HCP Patients IFU
10/08/2020	Beckman Coulter, Inc.	Access SARS-CoV-2 IgM	IgM, CLIA	H, M	HCP Recipients IFU
10/08/2020	Spectrum Solutions LLC	SDNA-1000 Saliva Collection Device	Saliva Collection Device	N/A	EUA Summary
10/07/2020	GenMark Diagnostics, Inc.	ePlex Respiratory Pathogen Panel 2	RT-PCR and electro-chemical detection, Multi-analyte	H, M	HCP Patients IFU
10/06/2020	University of California, Los Angeles (UCLA)	UCLA SwabSeq COVID-19 Diagnostic Platform	RT-PCR and Sequencing	H	HCP Patients EUA Summary
10/06/2020	ZEUS Scientific, Inc.	ZEUS ELISA SARS-CoV-2 IgG Test System	IgG, ELISA	H, M	HCP Recipients IFU
10/05/2020	Season Biomaterials, Inc.	AQ-TOP COVID-19 Rapid Detection Kit PLUS	RT-LAMP	H	HCP Patients IFU
10/02/2020	Quidel Corporation	Sofia 2 Flu + SARS Antigen FIA	Lateral Flow, Fluore-scence, Instrument Read, Multi-Analyte	H, M, W	HCP Patients IFU
10/02/2020	Thermo Fisher Scientific	OmniPATH COVID-19 Total Antibody ELISA Test	Total Antibody, ELISA	H, M	HCP Recipients IFU
10/02/2020	BioFire Diagnostics, LLC	BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ)	RT, Nested multiplex PCR, Multi-Analyte	H, M, W	HCP Patients IFU
10/01/2020	Beckman Coulter, Inc.	Access IL-6	One-step immuno-enzymatic ("sandwich") assay, IL-6	H, M	HCP Patients IFU
10/01/2020	UMass Memorial Medical Center	UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel	Real-time RT-PCR	H	HCP Patients EUA Summary
10/01/2020	Tempus Labs, Inc.	iC SARS-CoV2 Test	Real-time RT-PCR	H	HCP Patients EUA Summary
09/30/2020	Aeon Global Health	Aeon Global Health SARS-CoV-2 Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
09/30/2020	Alimetrix, Inc.	Alimetrix SARS-CoV-2 RT-PCR Assay	RT-PCR, Microarray Hybridization	H	HCP Patients EUA Summary
09/29/2020	CENTOGENE US, LLC	CentoSure SARS-CoV-2 RT-PCR Assay	Real-time RT-PCR, Screening	H	HCP Patients EUA Summary
09/29/2020	Akron Children’s Hospital	Akron Children’s Hospital SARS-CoV-2 Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
09/29/2020	National Jewish Health	SARS-CoV-2 MassArray Test	RT-PCR and MALDI-TOF Mass Spec.	H	HCP Patients EUA Summary
09/29/2020	DiaSorin, Inc.	DiaSorin LIAISON SARS-CoV-2 IgM Assay	IgM, Indirect CLIA	H, M	HCP Recipients IFU
09/29/2020	NanoEntek America, Inc.	FREND COVID-19 total Ab	Total Antibody, FIA	H, M	HCP Recipients IFU
09/29/2020	Nirmidas Biotech, Inc.	Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit	IgM and IgG, Lateral Flow	H, M	HCP Recipients IFU
09/25/2020	Genetrack Biolabs, Inc.	Genetrack SARS-CoV-2 Molecular Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
09/25/2020	Quotient Suisse SA	MosaiQ COVID-19 Antibody Magazine	Total Antibody, photometric immuno-assay	H	HCP Recipients IFU
09/24/2020	Cepheid	Xpert Xpress SARS-CoV-2/Flu/RSV	Real-time RT-PCR, Multi-analyte	H, M, W	HCP Patients IFU for Labs IFU for Point-of-Care
09/23/2020	Jiangsu Well Biotech Co., Ltd.	Orawell IgM/IgG Rapid Test	IgM and IgG, Lateral Flow	H, M	HCP Recipients IFU
09/23/2020	Clear Labs, Inc.	Clear Dx SARS-CoV-2 Test	RT-PCR and Sequencing	H	HCP Patients IFU
09/22/2020	Quadrant Biosciences Inc.	Clarifi COVID-19 Test Kit	Real-time RT-PCR, Saliva	H	HCP Patients IFU
09/22/2020	Vela Operations Singapore Pte. Ltd.	ViroKey SARS-CoV-2 RT-PCR Test v2.0	Real-time RT-PCR	H	HCP Patients IFU
09/21/2020	KimForest Enterprise Co., Ltd.	KimForest SARS-CoV-2 Detection Kit v1	Real-time RT-PCR	H	HCP Patients IFU
09/18/2020	GK Pharmaceuticals Contract Manufacturing Operations	GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT	Real-time RT-PCR	H	HCP Patients IFU
09/16/2020	Visby Medical, Inc.	Visby Medical COVID-19	RT-PCR	H, M	HCP Patients IFU
09/14/2020	Roche Molecular Systems, Inc.	cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System	Real-time RT-PCR, Multi-analyte	H, M, W	HCP Patients IFU
09/14/2020	Shenzhen New Industries Biomedical Engineering Co., Ltd.	MAGLUMI 2019-nCoV IgM/IgG	IgM and IgG, CLIA	H, M	HCP Recipients IFU
09/09/2020	BioCheck, Inc.	BioCheck SARS-CoV-2 IgM Antibody Test Kit	IgM, CLIA	H, M	HCP Recipients IFU
09/09/2020	BioCheck, Inc.	BioCheck SARS-CoV-2 IgG Antibody Test Kit	IgG, CLIA	H, M	HCP Recipients IFU
09/09/2020	Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.	Wantai SARS-CoV-2 RT-PCR Kit	Real-time RT-PCR	H	HCP Patients IFU
09/08/2020	Verily Life Sciences	Verily COVID-19 RT-PCR Test	Real-time RT-PCR, Pooling	H	HCP Patients EUA Summary
09/04/2020	BillionToOne, Inc.	qSanger-COVID-19 Assay	Sequencing	H	HCP Patients IFU
09/03/2020	Sugentech, Inc.	SGTi-flex COVID-19 IgG	IgG, Lateral Flow	H, M	HCP Recipients IFU
09/03/2020	Roche Molecular Systems, Inc.	cobas SARS-CoV-2 & Influenza A/B	Real-time RT-PCR, Multi-analyte	H, M	HCP Patients IFU
09/02/2020	Real-time RT-PCR	Bio-Speedy Direct RT-qPCR SARS-CoV-2	Molecular	H	HCP Patients IFU
09/01/2020	Detectachem Inc.	MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit	RT-LAMP	H	HCP Patients IFU
09/01/2020	OPTOLANE Technologies, Inc.	Kaira 2019-nCoV Detection Kit	Real-time RT-PCR	H	HCP Patients IFU
08/31/2020	TBG Biotechnology Corp.	TBG SARS-CoV-2 IgG / IgM Rapid Test Kit	IgM and IgG, Lateral Flow	H, M	HCP Recipients IFU
08/31/2020	University of Arizona Genetics Core for Clinical Services	COVID-19 ELISA pan-Ig Antibody Test	Total Antibody, ELISA	H	HCP Recipients EUA Summary
08/31/2020	T2 Biosystems, Inc.	T2SARS-CoV-2 Panel	RT, amplification, T2 Magnetic resonance	H	HCP Patients IFU
08/31/2020	MiraDx	MiraDx SARS-CoV-2 RT-PCR Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
08/31/2020	Mammoth Biosciences, Inc.	SARS-CoV-2 DETECTR Reagent Kit	RT-LAMP, CRISPR	H	HCP Patients IFU
08/31/2020	BayCare Laboratories, LLC	BayCare SARS-CoV-2 RT PCR Assay	Real-time RT-PCR, Pooling	H	HCP Patients EUA Summary
08/31/2020	Color Genomics, Inc.	Color COVID-19 Self-Swab Collection Kit	Home Collection Kit		EUA Summary IFU
08/28/2020	Patients Choice Laboratories, LLC	PCL SARS-CoV-2 Real-Time RT-PCR Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
08/28/2020	DxTerity Diagnostics, Inc.	DxTerity SARS-CoV-2 RT PCR CE Test	Real-time RT-PCR, Home Collection, Screening, Saliva	H	HCP Patients EUA Summary IFU (Home Collect)
08/26/2020	Cuur Diagnostics	Cuur Diagnostics SARS-CoV-2 Molecular Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
08/26/2020	Abbott Diagnostics Scarborough, Inc.	BinaxNOW COVID-19 Ag Card	Antigen Lateral Flow, Visual Read	H, M, W	HCP Patients IFU
08/25/2020	Biocan Diagnostics Inc.	Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test	IgM and IgG, Lateral Flow	H, M	HCP Recipients IFU
08/25/2020	Fluidigm Corporation	Advanta Dx SARS-CoV-2 RT-PCR Assay	Real-time RT-PCR, Saliva	H	HCP Patients IFU
08/25/2020	QDx Pathology Services	QDX SARS-CoV-2 Assay	Real-time RT-PCR, Home Collection	H	HCP Patients EUA Summary IFU (Home Collect)
08/21/2020	Guardant Health, Inc.	Guardant-19	Sequencing	H	HCP Patients EUA Summary
08/21/2020	DxTerity Diagnostics, Inc.	DxTerity SARS-CoV-2 RT-PCR Test	Real-time RT-PCR, Saliva	H	HCP Patients EUA Summary
08/21/2020	Texas Department of State Health Services, Laboratory Services Section	Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
08/18/2020	LumiraDx UK Ltd.	LumiraDx SARS-CoV-2 Ag Test	Antigen Microfluidic Immuno-fluorescence Assay, Instrument Read	H, M, W	HCP Patients IFU
08/17/2020	BioCheck, Inc.	BioCheck SARS-CoV-2 IgG and IgM Combo Test	IgM and IgG, CLIA	H, M	HCP Recipients IFU
08/17/2020	Diazyme Laboratories, Inc.	Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit	IgM, CLIA	H, M	HCP Recipients IFU
08/17/2020	ZhuHai Sinochips Bioscience Co., Ltd.	COVID-19 Nucleic Acid RT-PCR Test Kit	Real-time RT-PCR	H	HCP Patients IFU
08/15/2020	Yale School of Public Health, Department of Epidemiology of Microbial Diseases	SalivaDirect	Real-time RT-PCR, Saliva	H	HCP Patients EUA Summary
08/13/2020	Pro-Lab Diagnostics	Pro-AmpRT SARS-CoV-2 Test	RT, Isothermal amplification	H	HCP Patients EUA Summary
08/11/2020	Biomeme, Inc.	Biomeme SARS-CoV-2 Real-Time RT-PCR Test	Real-time RT-PCR	H	HCP Patients IFU
08/11/2020	LumiraDx UK Ltd.	LumiraDx SARS-CoV-2 RNA STAR	RT, non-isothermal nucleic acid amplification qSTAR	H	HCP Patients IFU
08/10/2020	Solaris Diagnostics	Solaris Multiplex SARS-CoV-2 Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
08/10/2020	Alpha Genomix Laboratories	Alpha Genomix TaqPath SARS-CoV-2 Combo Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
08/07/2020	George Washington University Public Health Laboratory	GWU SARS-CoV-2 RT-PCR Test	Real-time RT-PCR	H	HCP Patients EUA Summary
08/06/2020	bioMérieux SA	VIDAS SARS-CoV-2 IgM	IgM, ELFA	H, M	HCP Recipients IFU
08/06/2020	bioMérieux SA	VIDAS SARS-CoV-2 IgG	IgG, ELFA	H, M	HCP Recipients IFU
08/06/2020	Helix OpCo LLC (dba Helix)	Helix COVID-19 NGS Test	Sequencing	H	HCP Patients EUA Summary
08/05/2020	Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.	WANTAI SARS-CoV-2 Ab ELISA	Total Antibody, ELISA	H	HCP Recipients IFU
08/05/2020	Vela Operations Singapore Pte Ltd.	ViroKey SARS-CoV-2 RT-PCR Test	Real-time RT-PCR	H	HCP Patients IFU
08/03/2020	ISPM Labs, LLC dba Capstone Healthcare	Genus SARS-CoV-2 Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
08/03/2020	Wren Laboratories LLC	Wren Laboratories COVID-19 PCR Test	Real-time RT-PCR	H	HCP Patients EUA Summary
08/03/2020	Ethos Laboratories	Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay	RT-PCR and MALDI-TOF Mass Spec.	H	HCP Patients EUA Summary IFU (Home Collect)
08/03/2020	Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute	Cleveland Clinic SARS-CoV-2 Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
08/03/2020	Poplar Healthcare	Poplar SARS-CoV-2 TMA Pooling Assay	TMA, chemiluminescent, Pooling	H	HCP Patients EUA Summary
07/31/2020	Siemens Healthcare Diagnostics Inc.	Atellica IM SARS-CoV-2 IgG (COV2G)	IgG, Semi-quantitative	H, M	HCP Recipients IFU
07/31/2020	Siemens Healthcare Diagnostics Inc.	ADVIA Centaur SARS-CoV-2 IgG (COV2G)	IgG, Semi-quantitative	H, M	HCP Recipients IFU
07/31/2020	Xiamen Zeesan Biotech Co., Ltd.	SARS-CoV-2 Test Kit (Real-time PCR)	Real-time RT-PCR	H	HCP Patients IFU
07/31/2020	University of California San Diego Health	UCSD RC SARS-CoV-2 Assay	Real-time RT-PCR, Pooling	H	HCP Patients EUA Summary
07/30/2020	Clinical Reference Laboratory, Inc.	CRL Rapid Response	Real-time RT-PCR, Home Collection, Saliva	H	HCP Patients EUA Summary IFU (Home Collect)
07/27/2020	Eli Lilly and Company	Lilly SARS-CoV-2 Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
07/27/2020	Sandia National Laboratories	SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
07/24/2020	Xiamen Biotime Biotechnology Co., Ltd.	BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test	IgM and IgG, Lateral Flow	H, M	HCP Recipients IFU
07/24/2020	Access Bio, Inc.	CareStart COVID-19 IgM/IgG	IgM and IgG, Lateral Flow	H, M	HCP Recipients IFU
07/24/2020	Jiangsu CoWin Biotech Co., Ltd.	Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluore-scence Probing)	Real-time RT-PCR	H	HCP Patients IFU
07/23/2020	Helix OpCo LLC (dba Helix)	Helix COVID-19 Test	Real-time RT-PCR	H	HCP Patients EUA Summary
07/21/2020	DiaCarta, Inc.	QuantiVirus SARS-CoV-2 Multiplex Test Kit	Real-time RT-PCR	H	HCP Patients IFU
07/17/2020	Megna Health, Inc.	Rapid COVID-19 IgM/IgG Combo Test Kit	IgM and IgG, Lateral Flow	H, M	HCP Recipients IFU
07/17/2020	Access Genetics, LLC	OraRisk COVID-19 RT-PCR	Real-time RT-PCR	H	HCP Patients EUA Summary
07/16/2020	Boston Heart Diagnostics	Boston Heart COVID-19 RT-PCR Test	Real-time RT-PCR	H	HCP Patients EUA Summary
07/16/2020	Luminex Corporation	xMAP SARS-CoV-2 Multi-Antigen IgG Assay	IgG, FMIA	H	HCP Recipients IFU
07/15/2020	Quest Diagnostics Infectious Disease, Inc.	Quest Diagnostics PF SARS-CoV-2 Assay	Real-time RT-PCR, Home Collection	H	HCP Patients EUA Summary IFU (Home Collect)
07/15/2020	Quest Diagnostics Infectious Disease, Inc.	Quest Diagnostics RC SARS-CoV-2 Assay	Real-time RT-PCR, Home Collection	H	HCP Patients EUA Summary IFU (Home Collect)
07/15/2020	Quest Diagnostics Infectious Disease, Inc.	Quest Diagnostics HA SARS-CoV-2 Assay	TMA, chemiluminescent, Home Collection	H	HCP Patients EUA Summary IFU (Home Collect)
07/13/2020	Salofa Oy	Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette	IgM and IgG, Lateral Flow	H, M	HCP Recipients IFU
07/13/2020	KogeneBiotech Co., Ltd.	PowerChek 2019-nCoV Real-time PCR Kit	Real-time RT-PCR	H	HCP Patients IFU
07/13/2020	Trax Management Services Inc.	PhoenixDx SARS-CoV-2 Multiplex	Real-time RT-PCR	H	HCP Patients IFU
07/13/2020	Compass Laboratory Services, LLC	Compass Laboratory Services SARS-CoV2 Assay	Real-time RT-PCR, Home Collection	H	HCP Patients EUA Summary
07/10/2020	Boston Medical Center	BMC-CReM COVID-19 Test	Real-time RT-PCR	H	HCP Patients EUA Summary
07/10/2020	Beijing Wantai Biological Pharmacy Enterprise Co., Ltd	WANTAI SARS-CoV-2 Ab Rapid Test	Total Antibody, Lateral Flow	H, M	HCP Recipients IFU
07/09/2020	UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin	SARS-CoV-2 RNA DETECTR Assay	RT-LAMP	H	HCP Patients EUA Summary
07/09/2020	BioSewoom, Inc.	Real-Q 2019-nCoV Detection Kit	Real-time RT-PCR	H	HCP Patients IFU
07/08/2020	Diazyme Laboratories, Inc.	Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit	IgG, CLIA	H, M	HCP Recipients IFU
07/08/2020	Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard	CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
07/07/2020	Enzo Life Sciences, Inc.	AMPIPROBE SARS-CoV-2 Test System	Real-time RT-PCR	H	HCP Patients IFU
07/07/2020	Access Bio, Inc.	CareStart COVID-19 MDx RT-PCR	Real-time RT-PCR	H	HCP Patients IFU
07/07/2020	Gene By Gene	Gene By Gene SARS-CoV-2 Detection Test	Real-time RT-PCR	H	HCP Patients EUA Summary
07/06/2020	Assure Tech. (Hangzhou Co., Ltd)	Assure COVID-19 IgG/IgM Rapid Test Device	IgM and IgG, Lateral Flow	H, M	HCP Recipients IFU
07/06/2020	Laboratorio Clinico Toledo	Laboratorio Clinico Toledo SARS-CoV-2 Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
07/02/2020	Becton, Dickinson and Company (BD)	BD Veritor System for Rapid Detection of SARS-CoV-2	Antigen Chromato-graphic Digital Immuno-assay, Instrument Read	H, M, W	HCP Patients IFU
07/02/2020	Centers for Disease Control and Prevention (CDC)	Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay	Real-time RT-PCR, Multi-analyte	H	HCP Patients IFU
07/01/2020	CENTOGENE US, LLC	CentoFast-SARS-CoV-2 RT-PCR Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
06/30/2020	InBios International, Inc.	SCoV-2 Detect IgM ELISA	IgM, ELISA	H	HCP Recipients IFU
06/30/2020	Psomagen, Inc.	Psoma COVID-19 RT Test	Real-time RT-PCR	H	HCP Patients EUA Summary
06/30/2020	TNS Co., Ltd (Bio TNS)	COVID-19 RT-PCR Peptide Nucleic Acid (PNA) Kit	RT-PCR	H	HCP Patients IFU
06/30/2020	The Kroger Co.	Kroger Health COVID-19 Test Home Collection Kit	Home Collection Kit		IFU EUA Summary