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 January 5, 2021, there are 281 in vitro diagnostic EUAs (203 molecular/collection, 11 antigen, 64 serology, 3 COVID-19 management IVD) and 133 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 (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. There are several types of SARS-CoV-2 and COVID-19 related IVDs:

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

Serology/Antibody Tests - Tests that detect antibodies (e.g., IgM, IgG) to the SARS-CoV-2 virus. Serology/antibody tests cannot be used to diagnose a current infection.

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

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
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
06/29/2020	LifeHope Labs	LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel	Real-time RT-PCR	H	HCP Patients EUA Summary
06/29/2020	Acupath Laboratories, Inc.	Acupath COVID-19 Real-Time (RT-PCR) Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
06/26/2020	Beckman Coulter, Inc.	Access SARS-CoV-2 IgG	IgG , CLIA	H, M	HCP Recipients IFU
06/26/2020	Inform Diagnostics, Inc.	Inform Diagnostics SARS-CoV-2 RT-PCR Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
06/25/2020	Diagnostic Solutions Laboratory, LLC	DSL COVID-19 Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
06/25/2020	PreciGenome LLC	FastPlex Triplex SARS-CoV-2 Detection kit (RT-Digital PCR)	RT-digital droplet PCR	H	HCP Patients IFU
06/25/2020	PlexBio Co., Ltd.	IntelliPlex SARS-CoV-2 Detection Kit	RT-PCR	H	HCP Patients IFU
06/24/2020	University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory	MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
06/23/2020	HealthQuest Esoterics	HealthQuest Esoterics TaqPath SARS-CoV-2 Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
06/23/2020	University of Alabama at Birmingham Fungal Reference Lab	FRL SARS CoV-2 Test	Real-time RT-PCR	H	HCP Patients EUA Summary
06/23/2020	Gencurix, Inc.	GenePro SARS-CoV-2 Test	Real-time RT-PCR	H	HCP Patients IFU
06/23/2020	Babson Diagnostics, Inc.	Babson Diagnostics aC19G1	IgG , CLIA	H	HCP Recipients EUA Summary
06/19/2020	Hangzhou Laihe Biotech Co., Ltd.	LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)	IgM and IgG Lateral Flow	H, M	HCP Recipients IFU
06/18/2020	Biohit Healthcare (Hefei) Co. Ltd.	Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit	IgM and IgG Lateral Flow	H, M	HCP Recipients IFU
06/18/2020	Jiangsu Bioperfectus Technologies Co., Ltd.	COVID-19 Coronavirus Real Time PCR Kit	Real-time RT-PCR	H	HCP Patients IFU
06/18/2020	3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.	TRUPCR SARS-CoV-2 Kit	Real-time RT-PCR	H	HCP Patients IFU
06/17/2020	The Ohio State University Wexner Medical Center	OSUWMC COVID-19 RT-PCR Test	Real-time RT-PCR	H	HCP Patients EUA Summary
06/17/2020	Omnipath-ology Solutions Medical Corporation	Omni COVID-19 Assay by RT-PCR	Real-time RT-PCR	H	HCP Patients EUA Summary
06/15/2020	Applied BioCode, Inc.	BioCode SARS-CoV-2 Assay	RT-PCR	H	HCP Patients IFU
06/15/2020	Emory Medical Laboratories	SARS-CoV-2 RBD IgG Test	Serology IgG	H	HCP Recipients EUA Summary
06/13/2020	Kaiser Permanente Mid-Atlantic States	KPMAS COVID-19 Test	Real-time RT-PCR, Home Collection, Screening	H	HCP Patients EUA Summary IFU (Home Collect)
06/12/2020	RTA Laboratories Biological Products Pharma-ceutical and Machinery Industry	Diagnovital SARS-CoV-2 Real-Time PCR Kit	Real-time RT-PCR	H	HCP Patients IFU
06/10/2020	InBios International, Inc.	SCoV-2 Detect IgG ELISA	Serology IgG	H	HCP Recipients IFU
06/10/2020	Tide Laboratories, LLC	DTPM COVID-19 RT-PCR Test	Real-time RT-PCR	H	HCP Patients EUA Summary
06/10/2020	TBG Biotechnology Corp.	ExProbe SARS-CoV-2 Testing Kit	Real-time RT-PCR	H	HCP Patients IFU
06/10/2020	Cue Health Inc.	Cue COVID-19 Test	RT, Isothermal amplification	H, W, M	HCP Patients IFU
06/09/2020	Illumina, Inc.	Illumina COVIDSeq Test	Sequencing	H	HCP Patients IFU
06/09/2020	ChromaCode Inc.	HDPCR SARS-CoV-2 Assay	Real-time RT-PCR	H	HCP Patients IFU
06/08/2020	Siemens Healthcare Diagnostics Inc.	Dimension EXL SARS-CoV-2 Total Antibody Assay (CV2T)	Total Antibody	H, M	HCP Recipients IFU
06/08/2020	Euroimmun US Inc.	EURO RealTime SARS-CoV-2	Real-time RT-PCR	H	HCP Patients IFU
06/05/2020	Genetron Health (Beijing) Co., Ltd.	Genetron SARS-CoV-2 RNA Test	Real-time RT-PCR	H	HCP Patients IFU
06/04/2020	Vibrant America Clinical Labs	Vibrant COVID-19 Ab Assay	Serology IgM and IgG	H	HCP Recipients EUA Summary
06/04/2020	Phosphorus Diagnostics LLC	Phosphorus COVID-19 RT-qPCR Test	Real-time RT-PCR, Home Collection, Saliva	H	HCP Patients EUA Summary IFU (Home Collect) IFU (Clinic)
06/04/2020	Hangzhou Biotest Biotech Co., Ltd.	RightSign COVID-19 IgG/IgM Rapid Test Cassette	Serology IgM and IgG	H	HCP Recipients IFU
06/02/2020	Roche Diagnostics	Elecsys IL-6	Immuno-assay IL-6	H, M	HCP Patients IFU
06/01/2020	Gravity Diagnostics, LLC	Gravity Diagnostics COVID-19 Assay	Real-time RT-PCR, Home Collection	H	HCP Patients EUA Summary
05/29/2020	Healgen Scientific LLC	COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)	Serology IgM and IgG	H, M	HCP Recipients IFU
05/29/2020	Siemens Healthcare Diagnostics Inc.	Atellica IM SARS-CoV-2 Total (COV2T)	Total Antibody	H, M	HCP Recipients IFU
05/29/2020	Siemens Healthcare Diagnostics Inc.	ADVIA Centaur SARS-CoV-2 Total (COV2T)	Total Antibody	H, M	HCP Recipients IFU
05/28/2020	PrivaPath Diagnostics, Inc.	LetsGet Checked Coronavirus (COVID-19) Test	TMA, chemiluminescent, Home Collection	H	HCP Patients IFU (Home Collect) EUA Summary
05/22/2020	dba SpectronRx	Hymon SARS-CoV-2 Test Kit	Real-time RT-PCR	H	HCP Patients IFU
05/22/2020	Exact Sciences Laboratories	SARS-CoV-2 (N gene detection) Test	Real-time RT-PCR, Home Collection	H	HCP Patients EUA Summary IFU (Home Collect)
05/21/2020	BioCore Co., Ltd.	BioCore 2019-nCoV Real Time PCR Kit	Real-time RT-PCR	H	HCP Patients IFU
05/21/2020	SolGent Co., Ltd.	DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit	Real-time RT-PCR	H	HCP Patients IFU
05/21/2020	Seasun Biomaterials, Inc.	AQ-TOP COVID-19 Rapid Detection Kit	RT-LAMP	H	HCP Patients IFU
05/21/2020	P23 Labs, LLC.	P23 Labs TaqPath SARS-CoV-2 Assay	Real-time RT-PCR, Home Collection, Saliva	H	HCP Patients IFU1 (Home Collect) IFU2 (Home Collect) EUA Summary
05/18/2020	Quidel Corporation	Lyra Direct SARS-CoV-2 Assay	Real-time RT-PCR	H	HCP Patients IFU
05/18/2020	Color Genomics, Inc.	Color SARS Cov-2 Diagnostic Assay	RT, LAMP, Home Collection	H	HCP Patients EUA Summary IFU (Home Collect) IFU (On-site Collect)
05/15/2020	Everlywell, Inc.	Everlywell COVID-19 Test Home Collection Kit	Home Collection Kit	N/A	HCP EFU Summary
05/15/2020	Fulgent Therapeutics, LLC	Fulgent COVID-19 by RT-PCR Test	Real-time RT-PCR, Home Collection	H	HCP Patients EUA Summary
05/15/2020	Assurance Scientific Laboratories	Assurance SARS-CoV-2 Panel	Real-time RT-PCR, Home Collection	H	HCP Patients EUA Summary IFU (Home Collect)
05/14/2020	Hologic, Inc.	Aptima SARS-CoV-2 assay	TMA, chemiluminescent	H	HCP Patients IFU
05/14/2020	GeneMatrix, Inc.	NeoPlex COVID-19 Detection Kit	Real-time RT-PCR	H	HCP Patients IFU
05/13/2020	Applied DNA Sciences, Inc.	Linea COVID-19 Assay Kit	Real-time RT-PCR	H	HCP Patients IFU
05/11/2020	1drop Inc.	1copy COVID-19 qPCR Multi Kit	Real-time RT-PCR	H	HCP Patients IFU
05/11/2020	Abbott Molecular Inc.	Alinity m SARS-CoV-2 assay	Real-time RT-PCR	H, M	HCP Patients IFU
05/08/2020	Quidel Corporation	Sofia 2 SARS Antigen FIA	Antigen Lateral Flow, Fluore-scence, Instrument Read	H, M, W	HCP Patients IFU
05/08/2020	Gnomegen LLC	Gnomegen COVID-19-RT-qPCR Detection Kit	Real-time RT-PCR	H	HCP Patients IFU
05/07/2020	Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics - Rutgers University	Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-Assay	Real-time RT-PCR, Home Collection, Saliva	H	HCP Patients IFU (Home Collect) EUA Summary
05/07/2020	Zymo Research Corporation	Quick SARS-CoV-2rRT-PCR Kit	Real-time RT-PCR	H	HCP Patients IFU
05/06/2020	OPTI Medical Systems, Inc.	OPTI SARS-CoV-2 RT PCR Test	Real-time RT-PCR	H	HCP Patients IFU
05/06/2020	Sherlock BioSciences, Inc.	Sherlock CRISPR SARS-CoV-2 Kit	RT-LAMP, CRISPR	H	HCP Patients IFU
05/06/2020	BioMérieux SA	SARS-COV-2 R-GENE	Real-time RT-PCR	H	HCP Patients IFU
05/05/2020	Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company)	FTD SARS-CoV-2	Real-time RT-PCR	H	HCP Patients IFU
05/04/2020	EUROIMMUN US Inc.	Anti-SARS-CoV-2 ELISA (IgG)	Serology IgG	H	HCP Recipients IFU
05/04/2020	Sansure BioTech Inc.	Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluore-scence Probing)	Real-time RT-PCR	H	HCP Patients IFU
05/02/2020	Roche Diagnostics	Elecsys Anti-SARS-CoV-2	Serology Antibody	H, M	HCP Recipients IFU
05/01/2020	Bio-Rad Laboratories, Inc.	Bio-Rad SARS-CoV-2 ddPCR Test	RT-droplet PCR	H	HCP Patients IFU
05/01/2020	BioFire Diagnostics, LLC	BioFire Respiratory Panel 2.1 (RP2.1)	RT, Nested multiplex PCR, Multi-analyte	H, M	HCP Patients IFU
04/30/2020	Wadsworth Center, New York State Department of Health	New York SARS-CoV Microsphere Immunoassay for Antibody Detection	Serology Total Antibody	H	HCP Recipients EUA Summary
04/29/2020	LabGenomics Co., Ltd.	LabGun COVID-19 RT-PCR Kit	Real-time RT-PCR	H	HCP Patients IFU
04/29/2020	Rheonix, Inc.	Rheonix COVID-19 MDx Assay	RT-PCR	H	HCP Patients IFU
04/29/2020	Bio-Rad Laboratories	Platelia SARS-CoV-2 Total Ab assay	Serology Total Antibody	H	HCP Recipients IFU
04/27/2020	Seasun Biomaterials	U-TOP COVID-19 Detection Kit	Real-time RT-PCR	H	HCP Patients IFU
04/26/2020	Abbott Laboratories Inc.	SARS-CoV-2 IgG Assay	Serology IgG only	H, M	HCP Recipients IFU-ARCHITECT IFU-Alinity i Letter Granting EUA Amendment(s) (May 9, 2020)
04/24/2020	DiaSorin Inc.	LIAISON SARS-CoV-2 S1/S2 IgG	Serology IgG only	H, M	HCP Recipients IFU
04/24/2020	Ortho-Clinical Diagnostics, Inc.	VITROS Immuno-diagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack	Serology IgG only	H, M	HCP Recipients IFU
04/24/2020	Autobio Diagnostics Co. Ltd.	Anti-SARS-CoV-2 Rapid Test	Serology IgM and IgG	H, M	HCP Recipients IFU
04/23/2020	SD Biosensor, Inc.	STANDARD M nCoV Real-Time Detection Kit	Real-time RT-PCR	H	HCP Patients IFU
04/22/2020	altona Diagnostics GmbH	RealStar SARS-CoV02 RT-PCR Kits U.S.	Real-time RT-PCR	H	HCP Patients IFU
04/21/2020	Seegene, Inc.	Allplex 2019-nCoV Assay	Real-time RT-PCR	H	HCP Patients IFU
04/20/2020	Trax Management Services Inc.	PhoenixDx 2019-CoV	Real-time RT-PCR	H	HCP Patients IFU Letter Granting EUA Amendments (May 11, 2020)
04/18/2020	OSANG Healthcare	GeneFinder COVID-19 Plus RealAmp Kit	Real-time RT-PCR	H	HCP Patients IFU
04/17/2020	Fosun Pharma USA Inc.	Fosun COVID-19 RT-PCR Detection Kit	Real-time RT-PCR	H	HCP Patients IFU
04/16/2020	KorvaLabs Inc.	Curative-Korva SARS-Cov-2 Assay	Real-time RT-PCR	H	HCP Patients EUA Summary
04/16/2020	GenoSensor, LLC	GS™ COVID-19 RT-PCR KIT	Real-time RT-PCR	H	HCP Patients IFU
04/15/2020	Maccura Biotechnology (USA) LLC	SARS-CoV-2 Fluorescent PCR Kit	Real-time RT-PCR	H	HCP Patients IFU
04/15/2020	Mount Sinai Laboratory	COVID-19 ELISA IgG Antibody Test	Serology IgG	H	HCP Patients EUA Summary
04/14/2020	Ortho Clinical Diagnostics, Inc.	VITROS Immuno-diagnostic Products Anti-SARS-CoV-2 Total Reagent Pack	Serology Total Antibody	H, M	HCP Patients IFU Letter Granting EUA Amendment(s) (May 9, 2020)
04/10/2020	Atila BioSystems, Inc.	iAMP COVID-19 Detection Kit	RT, Isothermal amplification	H	HCP Patients IFU
04/08/2020	DiaCarta, Inc.	QuantiVirus SARS-CoV-2 Test Kit	Real-time RT-PCR	H	HCP Patients IFU
04/08/2020	Becton, Dickinson & Company	BD SARS-CoV-2 Reagents for BD MAX System	Real-time RT-PCR	H, M	HCP Patients IFU
04/07/2020	InBios International, Inc.	Smart Detect SARS-CoV-2 rRT-PCR Kit	Real-time RT-PCR	H	HCP  Patients IFU
04/06/2020	Gnomegen LLC	Gnomegen COVID-19 RT-Digital PCR Detection Kit	Real-time RT-digital PCR	H	HCP  Patients IFU Letter Granting EUA Amendment(s) (April 28, 2020)
04/03/2020	Co-Diagnostics, Inc.	Logix Smart Coronavirus Disease 2019 (COVID-19) Kit	RT-PCR, CoPrimer technology	H	HCP  Patients IFU
04/03/2020	ScienCell Research Laboratories	ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit	Real-time RT-PCR	H	HCP  Patients IFU
04/03/2020	Luminex Corporation	ARIES SARS-CoV-2 Assay	RT-PCR	H, M	HCP Patients IFU Letter Granting EUA Amendment(s) (May 11, 2020)
04/02/2020	Becton, Dickinson & Company (BD)	BioGX SARS-CoV-2 Reagents for BD MAX System	Real-time RT-PCR	H, M	HCP  Patients  IFU
04/01/2020	Ipsum Diagnostics, LLC	COV-19 IDx Assay	Real-time RT-PCR	H	HCP  Patients  EUA Summary
04/01/2020	Cellex Inc.	qSARS-CoV-2 IgG/IgM Rapid Test	Serology IgM and IgG	H, M	HCP Patients IFU
03/30/2020	QIAGEN GmbH	QIAstat-Dx Respiratory SARS-CoV-2 Panel	Real-time RT-PCR, Multi-analyte	H, M	HCP  Patients  IFU
03/30/2020	NeuMoDx Molecular, Inc.	NeuMoDx SARS-CoV-2 Assay	RT-PCR	H, M	HCP Patients IFU Letter Granting EUA Amendment(s) (April 23, 2020)
03/27/2020	Abbott Diagnostics Scarborough, Inc.	ID NOW COVID-19	RT, Isothermal amplification	H, M, W	HCP Patients IFU Letter Granting EUA Amendment(s) (April 21, 2020)
03/27/2020	Luminex Molecular Diagnostics, Inc.	NxTAG CoV Extended Panel Assay	RT-PCR	H	HCP Patients IFU
03/26/2020	BGI Genomics Co. Ltd.	Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV	Real-time RT-PCR	H	HCP Patients IFU Letter Granting EUA Amendment(s) (April 24, 2020)
03/25/2020	Avellino Lab USA, Inc.	AvellinoCoV2 Test	Real-time RT-PCR	H	HCP Patients EUA Summary
03/24/2020	PerkinElmer, Inc.	PerkinElmer New Coronavirus Nucleic Acid Detection Kit	Real-time RT-PCR	H	HCP Patients IFU Letter Granting EUA Amendment(s) (April 1, 2020)
03/23/2020	Mesa Biotech Inc.	Accula SARS-Cov-2 Test	RT and amplification	H, M, W	HCP Patients IFU Letter Granting EUA Amendment(s) (April 30, 2020)
03/23/2020	BioFire Defense, LLC	BioFire COVID-19 Test	RT, Nested multiplex PCR	H, M	HCP Patients IFU Letter Granting EUA Amendment(s) (April 30, 2020)
03/20/2020	Cepheid	Xpert Xpress SARS-CoV-2 Test	Real-time RT-PCR	H, M, W	HCP