EUA data source table

Date EUA Issued	Manufacturer	Diagnostic (Letter of Authorization)	Technology	Authorized Setting(s)	Authorization Documents: EUA Summary
9/9/2020	Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.	Wantai SARS-CoV-2 RT-PCR Kit	Molecular	H	None
9/8/2020	Verily Life Sciences	Verily COVID-19 RT-PCR Test	Molecular, Pooling	H	EUA Summary
9/4/2020	BillionToOne, Inc.	qSanger-COVID-19 Assay	Molecular	H	None
9/3/2020	Roche Molecular Systems, Inc.	cobas SARS-CoV-2 & Influenza A/B	Molecular, Multi-analyte	H, M	None
9/2/2020	Bioeksen R&D Technologies Ltd.	Bio-Speedy Direct RT-qPCR SARS-CoV-2	Molecular	H	None
9/1/2020	Detectachem Inc.	MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit	Molecular	H	None
9/1/2020	OPTOLANE Technologies, Inc.	Kaira 2019-nCoV Detection Kit	Molecular	H	None
8/31/2020	T2 Biosystems, Inc.	T2SARS-CoV-2 Panel	Molecular	H	None
8/31/2020	MiraDx	MiraDx SARS-CoV-2 RT-PCR assay	Molecular, Home Collection, Screening, Saliva	H	EUA Summary
8/31/2020	Mammoth Biosciences, Inc.	SARS-CoV-2 DETECTR Reagent Kit	Molecular	H	None
8/31/2020	BayCare Laboratories, LLC	BayCare SARS-CoV-2 RT PCR Assay	Molecular	H	EUA Summary
8/31/2020	Color Genomics, Inc.	Color COVID-19 Test Unmonitored Collection Kit	Home Collection Kit		EUA Summary
8/28/2020	Patients Choice Laboratories, LLC	PCL SARS-CoV-2 Real-Time RT-PCR Assay	Molecular	H	EUA Summary
8/28/2020	DxTerity Diagnostics, Inc.	DxTerity SARS-CoV-2 RT PCR CE Test	Molecular, Home Collection, Screening, Saliva	H	EUA Summary
8/26/2020	Cuur Diagnostics	Cuur Diagnostics SARS-CoV-2 Molecular Assay	Molecular	H	EUA Summary
8/25/2020	Fluidigm Corporation	Advanta Dx SARS-CoV-2 RT-PCR Assay	Molecular	H	None
8/25/2020	QDx Pathology Services	QDX SARS-CoV-2 Assay	Molecular, Home Collection	H	EUA Summary
8/21/2020	Guardant Health, Inc.	Guardant-19	Molecular	H	EUA Summary
8/21/2020	DxTerity Diagnostics, Inc.	DxTerity SARS-CoV-2 RT-PCR Test	Molecular	H	EUA Summary
8/21/2020	Texas Department of State Health Services, Laboratory Services Section	Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay	Molecular	H	EUA Summary
8/17/2020	ZhuHai Sinochips Bioscience Co., Ltd.	COVID-19 Nucleic Acid RT-PCR Test Kit	Molecular	H	None
8/15/2020	Yale School of Public Health, Department of Epidemiology of Microbial Diseases	SalivaDirect	Molecular	H	EUA Summary
8/13/2020	Pro-Lab Diagnostics	Pro-AmpRT SARS-CoV-2 Test	Molecular	H	EUA Summary
8/11/2020	Biomeme, Inc.	Biomeme SARS-CoV-2 Real-Time RT-PCR Test	Molecular	H	None
8/11/2020	LumiraDx UK Ltd.	LumiraDx SARS-CoV-2 RNA STAR	Molecular	H	None
8/10/2020	Solaris Diagnostics	Solaris Multiplex SARS-CoV-2 Assay	Molecular	H	EUA Summary
8/10/2020	Alpha Genomix Laboratories	Alpha Genomix TaqPath SARS-CoV-2 Combo Assay	Molecular	H	EUA Summary
8/7/2020	George Washington University Public Health Laboratory	GWU SARS-CoV-2 RT-PCR Test	Molecular	H	EUA Summary
8/6/2020	Helix OpCo LLC (dba Helix)	Helix COVID-19 NGS Test	Molecular	H	EUA Summary
8/5/2020	Vela Operations Singapore Pte Ltd	ViroKey SARS-CoV-2 RT-PCR Test	Molecular	H	None
8/3/2020	Wren Laboratories LLC	Wren Laboratories COVID-19 PCR Test	Molecular	H	EUA Summary
8/3/2020	Ethos Laboratories	Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay	Molecular, Home Collection	H	EUA Summary
8/3/2020	Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute	Cleveland Clinic SARS-CoV-2 Assay	Molecular	H	EUA Summary
8/3/2020	Poplar Healthcare	Poplar SARS-CoV-2 TMA Pooling assay	Molecular, Sample Pooling	H	EUA Summary
8/3/2020	ISPM Labs, LLC dba Capstone Healthcare	Genus SARS-CoV-2 Assay	Molecular	H	EUA Summary
7/31/2020	Xiamen Zeesan Biotech Co., Ltd.	SARS-CoV-2 Test Kit (Real-time PCR)	Molecular	H	None
7/31/2020	University of California San Diego Health	UCSD RC SARS-CoV-2 Assay	Molecular, Pooling	H	EUA Summary
7/30/2020	Clinical Reference Laboratory, Inc.	CRL Rapid Response	Molecular, Home Collection	H	EUA Summary
7/27/2020	Eli Lilly and Company	Lilly SARS-CoV-2 Assay	Molecular	H	EUA Summary
7/27/2020	Sandia National Laboratories	SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay	Molecular	H	EUA Summary
7/24/2020	Jiangsu CoWin Biotech Co., Ltd.	Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)	Molecular	H	None
7/23/2020	Helix OpCo LLC (dba Helix)	Helix COVID-19 Test	Molecular	H	EUA Summary
7/21/2020	DiaCarta, Inc.	QuantiVirus SARS-CoV-2 Multiplex Test Kit	Molecular	H	None
7/17/2020	Access Genetics, LLC	OraRisk COVID-19 RT-PCR	Molecular	H	EUA Summary
7/16/2020	Boston Heart Diagnostics	Boston Heart COVID-19 RT-PCR Test	Molecular	H	EUA Summary
7/15/2020	Quest Diagnostics Infectious Disease, Inc.	Quest Diagnostics PF SARS-CoV-2 Assay	Molecular, Home Collection	H	EUA Summary
7/15/2020	Quest Diagnostics Infectious Disease, Inc.	Quest Diagnostics RC SARS-CoV-2 Assay	Molecular, Home Collection	H	EUA Summary
7/15/2020	Quest Diagnostics Infectious Disease, Inc.	Quest Diagnostics HA SARS-CoV-2 Assay	Molecular, Home Collection	H	EUA Summary
7/13/2020	KogeneBiotech Co., Ltd.	PowerChek 2019-nCoV Real-time PCR Kit	Molecular	H	None
7/13/2020	Trax Management Services Inc.	PhoenixDx SARS-CoV-2 Multiplex	Molecular	H	None
7/13/2020	Compass Laboratory Services, LLC	Compass Laboratory Services SARS-CoV2 Assay	Molecular, Home Collection	H	EUA Summary
7/10/2020	Boston Medical Center	BMC-CReM COVID-19 Test	Molecular	H	EUA Summary
7/9/2020	UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin	SARS-CoV-2 RNA DETECTR Assay	Molecular	H	EUA Summary
7/9/2020	BioSewoom, Inc.	Real-Q 2019-nCoV Detection Kit	Molecular	H	None
7/8/2020	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	Molecular	H	EUA Summary
7/7/2020	Enzo Life Sciences, Inc.	AMPIPROBE SARS-CoV-2 Test System	Molecular	H	None
7/7/2020	Access Bio, Inc.	CareStart COVID-19 MDx RT-PCR	Molecular	H	None
7/7/2020	Gene By Gene	Gene By Gene SARS-CoV-2 Detection Test	Molecular	H	EUA Summary
7/6/2020	Laboratorio Clinico Toledo	Laboratorio Clinico Toledo SARS-CoV-2 Assay	Molecular	H	EUA Summary
7/2/2020	Centers for Disease Control and Prevention (CDC)	Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay	Molecular, Multi-analyte	H	None
7/1/2020	CENTOGENE US, LLC	CentoFast-SARS-CoV-2 RT-PCR Assay	Molecular	H	EUA Summary
6/30/2020	Psomagen, Inc.	Psoma COVID-19 RT Test	Molecular	H	EUA Summary
6/30/2020	TNS Co., Ltd (Bio TNS)	COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit	Molecular	H	None
6/30/2020	The Kroger Co.	Kroger Health COVID-19 Test Home Collection Kit	Home Collection Kit		EUA Summary
6/29/2020	LifeHope Labs	LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel	Molecular	H	EUA Summary
6/29/2020	Acupath Laboratories, Inc.	Acupath COVID-19 Real-Time (RT-PCR) Assay	Molecular	H	EUA Summary
6/26/2020	Inform Diagnostics, Inc.	Inform Diagnostics SARS-CoV-2 RT-PCR Assay	Molecular	H	EUA Summary
6/25/2020	Diagnostic Solutions Laboratory, LLC	DSL COVID-19 Assay	Molecular	H	EUA Summary
6/25/2020	PreciGenome LLC	FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR)	Molecular	H	None
6/25/2020	PlexBio Co., Ltd.	IntelliPlex SARS-CoV-2 Detection Kit	Molecular	H	None
6/24/2020	University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory	MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay	Molecular	H	EUA Summary
6/23/2020	HealthQuest Esoterics	HealthQuest Esoterics TaqPath SARS-CoV-2 Assay	Molecular	H	EUA Summary
6/23/2020	University of Alabama at Birmingham Fungal Reference Lab	FRL SARS CoV-2 Test	Molecular	H	EUA Summary
6/23/2020	Gencurix, Inc.	GenePro SARS-CoV-2 Test	Molecular	H	None
6/18/2020	Jiangsu Bioperfectus Technologies Co., Ltd.	COVID-19 Coronavirus Real Time PCR Kit	Molecular	H	None
6/18/2020	3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.	TRUPCR SARS-CoV-2 Kit	Molecular	H	None
6/17/2020	The Ohio State University Wexner Medical Center	OSUWMC COVID-19 RT-PCR test	Molecular	H	EUA Summary
6/17/2020	Omnipathology Solutions Medical Corporation	Omni COVID-19 Assay by RT-PCR	Molecular	H	EUA Summary
6/15/2020	Applied BioCode, Inc.	BioCode SARS-CoV-2 Assay	Molecular	H	None
6/13/2020	Kaiser Permanente Mid-Atlantic States	KPMAS COVID-19 Test	Molecular, Home Collection	H	EUA Summary
6/12/2020	RTA Laboratories Biological Products Pharmaceutical and Machinery Industry	Diagnovital SARS-CoV-2 Real-Time PCR Kit	Molecular	H	None
6/10/2020	Tide Laboratories, LLC	DTPM COVID-19 RT-PCR Test	Molecular	H	EUA Summary
6/10/2020	TBG Biotechnology Corp.	ExProbe SARS-CoV-2 Testing Kit	Molecular	H	None
6/10/2020	Cue Health Inc.	Cue COVID-19 Test	Molecular	H, M, W	None
6/9/2020	Illumina, Inc.	Illumina COVIDSeq Test	Molecular	H	None
6/9/2020	ChromaCode Inc.	HDPCR SARS-CoV-2 Assay	Molecular	H	None
6/8/2020	Euroimmun US, Inc.	EURORealTime SARS-Cov-2	Molecular	H	None
6/5/2020	Genetron Health (Beijing) Co., Ltd.	Genetron SARS-CoV-2 RNA Test	Molecular	H	None
6/4/2020	Phosphorus Diagnostics LLC	Phosphorus COVID-19 RT-qPCR Test	Molecular, Home Collection	H	EUA Summary,
6/1/2020	Gravity Diagnostics, LLC	Gravity Diagnostics COVID-19 Assay	Molecular	H	EUA Summary
5/28/2020	PrivaPath Diagnostics, Inc.	LetsGetChecked Coronavirus (COVID-19) Test	Molecular, Home Collection	H	EUA Summary
5/22/2020	dba SpectronRX	Hymon SARS-CoV-2 Test Kit	Molecular	H	None
5/22/2020	Exact Sciences Laboratories	SARS-CoV-2 (N gene detection) Test	Molecular, Home Collection	H	EUA Summary
5/21/2020	P23 Labs, LLC.	P23 Labs TaqPath SARS-CoV-2 Assay	Molecular, Home Collection	H	EUA Summary
5/21/2020	Seasun Biomaterials, Inc.	AQ-TOP COVID-19 Rapid Detection Kit	Molecular	H	None
5/21/2020	SolGent Co., Ltd	DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit	Molecular	H	None
5/21/2020	BioCore Co., Ltd.	BioCore 2019-nCoV Real Time PCR Kit	Molecular	H	None
5/18/2020	Quidel Corporation	Lyra Direct SARS-CoV-2 Assay	Molecular	H	None
5/18/2020	Color Genomics, Inc.	Color Genomics SARS-CoV-2 RT-LAMP Diagnostic Assay	Molecular, Home Collection	H	EUA Summary
5/15/2020	Fulgent Therapeutics, LLC	Fulgent COVID-19 by RT-PCR Test	Molecular, Home Collection	H	EUA Summary
5/15/2020	Everlywell, Inc.	Everlywell COVID-19 Test Home Collection Kit	Home Collection Kit	N/A	EUA Summary
5/15/2020	Assurance Scientific Laboratories	Assurance SARS-CoV-2 Panel	Molecular, Home Collection	H	EUA Summary
5/14/2020	Hologic, Inc.	Aptima SARS-CoV-2 assay	Molecular	H	None
5/14/2020	GeneMatrix, Inc.	NeoPlex COVID-19 Detection Kit	Molecular	H	None
5/13/2020	Applied DNA Sciences, Inc.	Linea COVID-19 Assay Kit	Molecular	H	None
5/11/2020	1drop Inc.	1copy COVID-19 qPCR Multi Kit	Molecular	H	None
5/11/2020	Abbott Molecular Inc.	Alinity m SARS-CoV-2 assay	Molecular	H, M	None
5/8/2020	Gnomegen LLC	Gnomegen COVID-19-RT-qPCR Detection Kit	Molecular	H	None
5/7/2020	Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics – Rutgers University	Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-Assay	Molecular, Home Collection	H	EUA Summary
5/7/2020	Zymo Research Corporation	Quick SARS-CoV-2rRT-PCR Kit	Molecular	H	None
5/6/2020	OPTI Medical Systems, Inc.	OPTI SARS-CoV-2 RT PCR Test	Molecular	H	None
5/6/2020	Sherlock BioSciences, Inc.	Sherlock CRISPR SARS-CoV-2 Kit	Molecular	H	None
5/6/2020	BioMérieux SA	SARS-COV-2 R-GENE	Molecular	H	None
5/5/2020	Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company)	FTD SARS-CoV-2	Molecular	H	None
5/4/2020	Sansure BioTech Inc.	Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	Molecular	H	None
5/1/2020	Bio-Rad Laboratories, Inc	Bio-Rad SARS-CoV-2 ddPCR Test	Molecular	H	None
5/1/2020	BioFire Diagnostics, LLC	BioFire Respiratory Panel 2.1 (RP2.1)	Molecular, Multi-analyte	H, M	None
4/29/2020	LabGenomics Co., Ltd.	LabGun COVID-19 RT-PCR Kit	Molecular	H	None
4/29/2020	Rheonix, Inc.	Rheonix COVID-19 MDx Assay	Molecular	H	None
4/27/2020	SEASUN BIOMATERIALS	U-TOP COVID-19 Detection Kit	Molecular	H	None
4/23/2020	SD Biosensor, Inc.	STANDARD M nCoV Real-Time Detection Kit	Molecular	H	None
4/22/2020	altona Diagnostics GmbH	RealStar SARS-CoV02 RT-PCR Kits U.S.	Molecular	H	None
4/21/2020	Seegene, Inc.	Allplex 2019-nCoV Assay	Molecular	H	None
4/20/2020	Trax Management Services Inc.	PhoenixDx 2019-CoV	Molecular	H	None
4/18/2020	OSANG Healthcare	GeneFinder COVID-19 Plus RealAmp Kit	Molecular	H	None
4/17/2020	Fosun Pharma USA Inc.	Fosun COVID-19 RT-PCR Detection Kit	Molecular	H	None
4/16/2020	KorvaLabs Inc.	Curative-Korva SARS-Cov-2 Assay	Molecular	H	EUA Summary
4/16/2020	GenoSensor, LLC	GS”¢ COVID-19 RT-PCR KIT	Molecular	H	None
4/15/2020	Maccura Biotechnology (USA) LLC	SARS-CoV-2 Fluorescent PCR Kit	Molecular	H	None
4/10/2020	Atila BioSystems, Inc.	iAMP COVID-19 Detection Kit	Molecular	H	None
4/8/2020	DiaCarta, Inc	QuantiVirus SARS-CoV-2 Test kit	Molecular	H	None
4/8/2020	Becton, Dickinson & Company	BD SARS-CoV-2Reagents for BD MAX System	Molecular	H, M	None
4/7/2020	InBios International, Inc	Smart Detect SARS-CoV-2 rRT-PCR Kit	Molecular	H	None
4/6/2020	Gnomegen LLC	Gnomegen COVID-19 RT-Digital PCR Detection Kit	Molecular	H	None
4/3/2020	Co-Diagnostics, Inc.	Logix Smart Coronavirus Disease 2019 (COVID-19) Kit	Molecular	H	None
4/3/2020	ScienCell Research Laboratories	ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit	Molecular	H	None
4/3/2020	Luminex Corporation	ARIES SARS-CoV-2 Assay	Molecular	H, M	None
4/2/2020	Becton, Dickinson & Company (BD)	BioGX SARS-CoV-2 Reagents for BD MAX System	Molecular	H, M	None
4/1/2020	Ipsum Diagnostics, LLC	COV-19 IDx assay	Molecular	H	EUA Summary
3/30/2020	QIAGEN GmbH	QIAstat-Dx Respiratory SARS-CoV-2 Panel	Molecular, Multi-analyte	H, M	None
3/30/2020	NeuMoDx Molecular, Inc.	NeuMoDx SARS-CoV-2 Assay	Molecular	H, M	None
3/27/2020	Luminex Molecular Diagnostics, Inc.	NxTAG CoV Extended Panel Assay	Molecular	H	None
3/27/2020	Abbott Diagnostics Scarborough, Inc.	ID NOW COVID-19	Molecular	H, M, W	None
3/26/2020	BGI Genomics Co. Ltd	Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2	Molecular	H	None
3/25/2020	Avellino Lab USA, Inc.	AvellinoCoV2 test	Molecular	H	EUA Summary
3/24/2020	PerkinElmer, Inc.	PerkinElmer New Coronavirus Nucleic Acid Detection Kit	Molecular	H	None
3/23/2020	Mesa Biotech Inc.	Accula SARS-Cov-2 Test	Molecular	H, M, W	None
3/23/2020	BioFire Defense, LLC	BioFire COVID-19 Test	Molecular	H, M	None
3/20/2020	Cepheid	Xpert Xpress SARS-CoV-2 test	Molecular	H, M, W
3/20/2020	Primerdesign Ltd.	Primerdesign Ltd COVID-19 genesig Real-Time PCR assay	Molecular	H	None
3/19/2020	GenMark Diagnostics, Inc.	ePlex SARS-CoV-2 Test	Molecular	H, M	None
3/19/2020	DiaSorin Molecular LLC	Simplexa COVID-19 Direct assay	Molecular	H, M	None
3/18/2020	Abbott Molecular	Abbott RealTime SARS-CoV-2 assay	Molecular	H	None
3/17/2020	Quest Diagnostics Infectious Disease, Inc.	Quest SARS-CoV-2 rRT-PCR	Molecular, Home Collection, Sample Pooling	H	None
3/17/2020	Quidel Corporation	Lyra SARS-CoV-2 Assay	Molecular	H	None
3/16/2020	Laboratory Corporation of America (LabCorp)	COVID-19 RT-PCR Test	Molecular, Home Collection, Pooling, Screening	H	EUA Summary
3/16/2020	Hologic, Inc.	Panther Fusion SARS-CoV-2 Assay	Molecular	H	None
3/13/2020	Thermo Fisher Scientific, Inc.	TaqPath COVID-19 Combo Kit	Molecular	H	None
3/12/2020	Roche Molecular Systems, Inc. (RMS)	cobas SARS-CoV-2	Molecular	H, M	None
2/29/2020	Wadsworth Center, New York State Department of Public Health’s (CDC)	New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel	Molecular	H	None
2/4/2020	Centers for Disease Control and Prevention’s (CDC)	CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC)	Molecular	H	None