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 October 26, 2020, there are 250 in vitro diagnostic EUAs (186 molecular/collection, 6 antigen, 56 serology, 2 COVID-19 management IVD) and 173 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
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	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 Patients IFU for Labs IFU for Point-of-Care Letter Granting EUA Amendment(s) (April 28, 2020)
03/20/2020	Primerdesign Ltd.	Primerdesign Ltd COVID-19 genesig Real-Time PCR Assay	Real-time RT-PCR	H	HCP Patients IFU Letter Granting EUA Amendment(s) (April 8, 2020)
03/19/2020	GenMark Diagnostics, Inc.	ePlex SARS-CoV-2 Test	RT-PCR and electro-chemical detection	H, M	HCP Patients IFU
03/19/2020	DiaSorin Molecular LLC	Simplexa COVID-19 Direct Assay	Real-time RT-PCR	H, M	HCP Patients IFU Letter Granting EUA Amendment(s) (March 26, 2020) Letter Granting EUA Amendment(s) (April 13, 2020)
03/18/2020	Abbott Molecular	Abbott RealTime SARS-CoV-2 Assay	Real-time RT-PCR	H	HCP Patients IFU Letter Granting EUA Amendment(s) (April 1, 2020)
03/17/2020	Quest Diagnostics Infectious Disease, Inc.	Quest SARS-CoV-2 rRT-PCR	Real-time RT-PCR, Home Collection, Pooling	H	HCP Patients IFU IFU (Home Collect)
03/17/2020	Quidel Corporation	Lyra SARS-CoV-2 Assay	Real-time RT-PCR	H	HCP Patients IFU Letter Granting EUA Amendment(s) (April 8, 2020)
03/16/2020	Laboratory Corporation of America (LabCorp)	COVID-19 RT-PCR Test	Real-time RT-PCR, Home Collection, Pooling, Screening	H	HCP Patients EUA Summary IFU (Pixel Home Collect) IFU (LabCorp Home Collect)
03/16/2020	Hologic, Inc.	Panther Fusion SARS-CoV-2	Real-time RT-PCR	H	HCP Patients IFU Letter Granting EUA Amendment(s) (April 24, 2020)
03/13/2020	Thermo Fisher Scientific, Inc.	TaqPath COVID-19 Combo Kit	Real-time RT-PCR	H	HCP Patients IFU Letter Granting EUA Amendment(s) (March 24, 2020) Letter Granting EUA Amendment(s) (April 20, 2020) Letter Granting EUA Amendment(s) (May 9, 2020)
03/12/2020	Roche Molecular Systems, Inc. (RMS)	cobas SARS-CoV-2	Real-time RT-PCR	H, M	HCP Patients IFU Letter Granting EUA Amendment(s) (March 31, 2020)
02/29/2020	Wadsworth Center, New York State Department of Public Health's (CDC)	New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel	Real-time RT-PCR	H	HCP Patients IFU Letter Granting EUA Amendment(s) (March 15, 2020)
02/04/2020	Centers for Disease Control and Prevention's (CDC)	CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC)	Real-time RT-PCR	H	HCP Patients IFU Letter Granting EUA Amendment(s) (March 30, 2020)

¹ Authorized settings include the following:

• H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
• M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
• W - Patient care settings operating under a CLIA Certificate of Waiver.

² Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.

³ Abbreviations:

• RT-PCR = reverse transcriptase polymerase chain reaction;
• RT = reverse transcriptase;
• LAMP = loop-mediated isothermal amplification;
• MALDI-TOF = Matrix Assisted Laser Desorption/Ionization - Time of Flight;
• TMA = Transcription Mediated Amplification;
• qSTAR = Selective Temperature Amplification Reaction;
• CRISPR = clustered regularly interspaced short palindromic repeats;
• CLIA = chemiluminescence immunoassay;
• ELISA = enzyme-linked immunosorbent assay;
• ECLIA = electrochemiluminescence immunoassay;
• FMIA = fluorescent microsphere immunoassay;
• CMIA = chemiluminescent microparticle immunoassay;
• ELFA = enzyme-linked fluorescence assay.

Commercial Manufacturers Distributing Test Kits Under the Policy Outlined in Section IV.C of the Policy for Coronavirus Disease-2019 Tests:

As stated in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution to clinical laboratories of diagnostic test kits to perform assays to detect SARS-CoV-2 for a reasonable period of time after the manufacturer's validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test's performance characteristics on the manufacturer's website. Transparency can help mitigate potential adverse impacts from a poorly designed test by facilitating better informed decisions by potential purchasers and users. As noted in the guidance, the believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high-complexity testing, including testing at the point-of-care when the site is covered by the laboratory's CLIA certificate for high-complexity testing. This policy does not apply to at home testing, including at-home specimen collection.

The commercial manufacturers listed below have notified FDA that they have validated and intend to distribute diagnostic test kits as set forth in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. If this designation is not shown, the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the test, and the test is included in this list to provide transparency regarding the notification submitted to FDA.

Manufacturer Notifications (71):

• AccuPower SARS-CoV-2 Multiplex Real-Time RT-PCR Kit
• Agena Bioscience SARS-CoV-2 Panel
• American BioSources Inc., DBA Genomic Diagnostics GDx GrandPerformance SARS-CoV-2 Detection Kit
• AMSBIOInc., A+CheQ COVID-19 High-Speed RT-qPCR Detection Kit
• BD BioGx SARS-CoV-2 Reagents for BD MAX System (FDA Authorized)
• BGI Genomics Co. Ltd (FDA Authorized)
• Biomeme, Inc. Biomeme SARS-CoV-2 Test Kit (FDA Authorized)
• BIONEER Corporation
• Biopoa, Co. Ltd., Rapid COVID-19 PoaCheck
• BioZentech Co., Ltd., BZ QPCR COVID-19 Kit
• Caspr Biotech Corporation, Caspr Lyo-CRISPR SARS-CoV-2
• Caspr Biotech Corporation, Direct Caspr Lyo-CRISPR SARS-CoV-2
• ChromaCode, Inc. HDPCR SARS-CoV-2 Assay (FDA Authorized)
• Clinomics USA Inc., TrioDx RT-PCR COVID-19 Test
• Co-Diagnostics, Inc. (FDA Authorized)
• Detectachem Inc., MD-Bio BCC19 (FDA Authorized)
• DowGene Co., Ltd., Dow QuickFinderTM 2019-nCov Real-Time PCR Kit
• ELITechGroup MDx LLC SARS-CoV-2 ELITe MGB Assay
• Enzo Biochem, Inc Enzo AMPIPROBE® SARS-CoV-2 Test System (FDA Authorized)
• Eryigit medical Devices, Sentebiolab Senteligo SARS CoV-2 (COVID-19) Multiplex qPCR Detection Kit
• Eurofins ARCA Technology, Inc., ARCA Straight Shot SARS-CoV-2 Extraction Free (EF) Assay
• Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay (FDA Authorized)
• Gencurix Inc. GenePro SARS-CoV-2 Test (FDA Authorized)
• GeneOne Diagnostics Corporation COVID-19 Nucleic Acid Diagnostic Kit
• General Biologicals Corporation, GB SARS-CoV-2 Real-Time RT-PCR
• GeneReach Biotechnology Corporation POCKIT Central SARS-CoV-2
• Genes Laboratories, NEXdiaTM 2019-nCoV Detection Kit
• Genetic Signatures Limited, EasyScreen™ SARS-CoV-2 Detection Kit
• GenMark Diagnostics, Inc. ePlex Respiratory Pathogen Panel 2 (ePlex RP2 Panel)
• GenMark Diagnostics, Inc., eSensor SARS-CoV-2 Panel
• Genomictree, Inc. AccuraDTect SARS-CoV-2-qPCR Kit
• Genrui Biotech Inc, Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR)
• Gerbion GmbH & Co. KG., Gerbion virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0
• GK Pharmaceuticals Contract Manufacturing Operations, ACCU-RIGHT SARS-COV-2 RT-PCR KIT
• Grifols Diagnostic Solutions Inc. Procleix SARS-CoV-2 Assay
• GUANGDONG ARDENT BIOMED Co., Ltd, Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit (PCR-fluorescent Probe)
• Hologic Aptima SARS-CoV-2 Assay Pooled Samples Workflow
• Hologic Panther Fusion SARS-CoV-2 Assay Pooled Samples Workflow (FDA Authorized)
• Hologic, Inc. Aptima SARS-CoV-2 Assay (FDA Authorized)
• iCubate, Inc., iC-COVID-19 Assay
• Illucidx Inc., Illucidx COVID-19 Dx RT-LAMP
• LabGenomics, Co., Ltd. LabGun™ COVID-19 Assay Kit (FDA Authorized)
• Melbourne Biotech MB QRT-PCR TEST SARS-COV2(COVID-19)
• MiCo BioMed Co., Ltd. Veri-Q COVID-19 Multiplex Detection Kit
• Molecular Epidemiology Inc., IEH SARS-CoV-2 RT-PCR Test
• Nanjing Liming Bio-Products Co., Ltd., StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit
• NovaTec Immundiagnosticsa GmBH GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR
• OPTOLANE Technologies Inc. Kaira 2019-nCoV Detection Kit (FDA Authorized)
• OSANG Healthcare Co., Ltd, GeneFinder COVID-19 Plus RealAmp Kit (FDA Authorized)
• ProteomeTech Inc. GENEdania COVID-19 qRT-PCR
• QIAGEN QIAstat-Dx Respiratory SARS-CoV-2 Panel Assay (FDA Authorized)
• Roche Molecular Systems Pooling Sample Workflow for the cobas® SARS-CoV-2 for use on the cobas® 6800/8800 Systems
• RTA Laboratuvarlari Biyolojik Urunler Ilac ve Makine San. Tic. A.S., Diagnovital SARS-CoV-2 Multiplex
• RTA Labs DIAGNOVITAL SARS-CoV-2 (FDA Authorized)
• SA Scientific, SAS™ COVID-19 Antibody Detection Test
• Sacace Biotechnologies s.r.1., SARS-CoV-2 Real-TM
• Sanigen Co. Ltd., Genelix™ COVID-19 Real-Time PCR Kit
• Shimadzu Corporation, 2019 Novel Coronavirus Detection Kit
• SML GENETREE Co., Ltd. Ezplex SARS-CoV-2 G Kit
• Solgent Co. Ltd., COVID-19 DiaplexQ Diagnostic Kit (FDA Authorized)
• Suzhou PreciGenome, Ltd., Co., Fastplex Triplex SARS-CoV-2 Detection Kit (RT-PCR)
• T2Biosystems, Inc., T2SARS-CoV-2 Panel (FDA Authorized)
• TAAG Genetics S.A. nPLEX SARS-CoV-2 Detection Kit
• Taigen Bioscience Corporation LabTurbo AIO COVID-19 RNA Testing Kit
• TCM Bioscience, TCM-Q Corona III Test
• Todos Medical USA Inc., TODOS 2019-nCoV RT-qPCR Detection Kit
• UStar Biotechnologies (Hangzhou) Ltd., EasyNAT® Diagnostic Kit for Novel-Coronavirus (COVID-19) RNA (Isothermal Amplification-Real Time Fluorescence Assay)
• Vela Operations Singapore Pte Ltd. ViroKey SARS-CoV-2 RT-PCR Test v2.0 (FDA Authorized)
• VelaDx ViroKey™ SARS-CoV-2 RT-PCR Test (FDA Authorized)
• YD Diagnostics Corp. MolecuTech Real-Time COVID-19
• ZhuHai Sinochips Bioscience Co., Ltd COVID-19 Real-time PCR Test Kit (FDA Authorized)

Laboratories Offering Serology Tests Under the Policy Outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests:

As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, while laboratories are encouraged to submit EUA requests for serology tests, the FDA does not intend to object to the development and use of serology tests to identify antibodies to SARS-CoV-2 by laboratories that are certified under CLIA to perform high-complexity testing, where the test has been validated, notification is provided to FDA, and information that helps users and patients understand the test results, such as the following, is included in the test reports:

• This test has not been reviewed by the FDA.
• Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
• Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

This policy does not apply to at-home testing, including at-home specimen collection.

The laboratories in the list below have notified the FDA that they have validated and intend to distribute a serology test as set forth in Section IV.D of the Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. If this designation is not shown, the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the manufacturer's test, and the test is included in this list to provide transparency regarding the notification submitted to the FDA.


If an EUA request is not submitted within a reasonable period of time, or if significant problems are identified with a test and cannot be or have not been addressed in a timely manner, FDA intends to remove the manufacturer and test from this list, would expect the manufacturer to suspend distribution of the test, and may take additional actions as appropriate.

Laboratory Notifications (30):

• Allermetrix, Inc.
• BioDiagnostic Labs LLC
• Brigham and Women's Hospital
• Center for Cellular Therapy Medical University of South Carolina
• Cincinnati Children's Hospital Medical Center
• CQuentia NGS, LLC
• DLS Research & Ventures
• EDP Biotech Corporation
• Emory Medical Laboratories
• Enzo Clinical Labs
• Ethos Laboratories
• Exsera Biolabs at the University of Colorado Anschutz Medical Campus
• Genalyte, Inc
• IGeneX Inc.
• IMMYLabs
• KSL Diagnostics
• LabCorp Center for Esoteric Testing
• Mayo Clinic
• OneBlood, Inc.
• Otogenetics
• Pan Laboratories
• Phosphorus Diagnostics LLC
• ProterixBio, Inc.
• Sciteck Diagnostics
• Stanford Health Care
• Symbiotica, Inc.
• University of Arizona Genetics Core for Clinical Services
• University of Minnesota Advanced Research and Diagnostic Laboratory
• Vibrant America Clinical Labs
• White Coat Sciences

Commercial Manufacturers Distributing Test Kits Under the Policy Outlined in Section IV.D of the Policy for Diagnostic Tests for Coronavirus Disease-2019:

As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution of serology tests to identify antibodies to SARS-CoV-2 for a reasonable period of time, where the test has been validated and while the manufacturer is preparing its EUA request, where the manufacturer gives notification to the FDA and information that helps users and patients understand the test results, such as the following, is included in the instructions for use:

• This test has not been reviewed by the FDA.
• Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
• Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

As noted in the guidance, the FDA believes that 10 business days is a reasonable period of time to prepare an EUA submission for such tests. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory's CLIA certificate for high-complexity testing.

This policy does not apply to at-home testing, including at-home specimen collection.

The commercial manufacturers in the list below have notified the FDA that they have validated and intend to distribute a serology test as set forth in Section IV.D of the Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. If this designation is not shown, the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the manufacturer's test, and the test is included in this list to provide transparency regarding the notification submitted to the FDA.
If an EUA request is not submitted within a reasonable period of time, or if significant problems are identified with a test and cannot be or have not been addressed in a timely manner, FDA intends to remove the manufacturer and test from this list, would expect the manufacturer to suspend distribution of the test, and may take additional actions as appropriate. Commercial manufacturers may also voluntarily withdraw their test notification. For these reasons, the number of tests listed below may change (up or down) on a daily basis.

Manufacturer Notifications (173):

• Abbott Laboratories SARS-CoV-2 IgG (for use on ARCHITECT) (FDA Authorized)
• Absology Co., Ltd. Absoludy COVID-19 IgM/IgG Combo
• Absology Co., Ltd. Absoludy COVID-19 IgM/IgG RAPID
• Absology Co., Ltd. INIST COVID-19 IgM/IgG RAPID
• Accel Diagnostics, LLC Rapid C2T Total Ab (IgG/IgM) Card
• Access Bio, Inc. CareStart COVID-19 IgM/IgG (FDA Authorized)
• ADVAITE, Inc. RapCov™ COVID-19 Rapid Test
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• AnyGo Technology Co., Ltd: COVID-19 Capture ELISA Assay
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• Bloom Diagnostics AG Bloom COVID-19 Test
• Boditech Med Inc AFIAS COVID-19 Ab serological tests
• Boston Bio Lab Inc. Boston Bio EZ Covid-19
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• Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. SARS-CoV-2 IgM/IgG Rapid Assay Kit (Colloidal Gold)
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• Qualigen, Inc. FastPack® SARS-CoV-2 IgG Immunoassay
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• Ring Biotechnology Co Ltd COVID-19 IgM/IgG Rapid Test Kit
• Roche Diagnostics GmbH Elecsys Anti-SARS-CoV-2 (FDA Authorized)
• SA Scientific Ltd. SAS™ COVID-19 Total Antibody Detection Test
• SA Scientific SAS™ COVID-19 Antibody Detection Test
• Salofa Oy Clarity COVIBLOCK™ COVID-19 IgG/IgM Antibody Test
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• ScheBo® • Biotech AG ScheBo® • SARS-CoV-2 Quick
• Sciteck Diagnostics COVID19 Automated Antibody Assay
• Shandong ThinkLab Biotechnology Co., Ltd.: 2019-nCoV IgM/IgG antibody Test Kit (Colloidal-gold Assay)
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