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 August 10, 2020, there are 174 in vitro diagnostic EUAs (134 molecular, 2 antigen, 37 serology, 1 COVID-19 management IVD) and 184 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 EUA Issued	Manufacturer	Letter of Authorization	Technology	Authorized Settings1	Authorization Documents2
08/07/2020	George Washington University Public Health Laboratory	GWU SARS-CoV-2 RT-PCR Test	Molecular	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	Molecular	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
08/06/2020	Vela Operations Singapore Pte Ltd.	ViroKey SARS-CoV-2 RT-PCR Test	Molecular	H	HCP Patients IFU
08/03/2020	ISPM Labs, LLC dba Capstone Healthcare	Genus SARS-CoV-2 Assay	Molecular	H	HCP Patients EUA Summary
08/03/2020	Wren Laboratories LLC	Wren Laboratories COVID-19 PCR Test	Molecular	H	HCP Patients EUA Summary
08/03/2020	Ethos Laboratories	Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay	Molecular, Home Collection	H	HCP Patients EUA Summary IFU
08/03/2020	Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute	Cleveland Clinic SARS-CoV-2 Assay	Molecular	H	HCP Patients EUA Summary
08/03/2020	Poplar Healthcare	Poplar SARS-CoV-2 TMA Pooling Assay	Molecular, Sample 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)	Molecular	H	HCP Patients IFU
07/31/2020	University of California San Diego Health	UCSD RC SARS-CoV-2 Assay	Molecular, Pooling	H	HCP Patients EUA Summary
07/30/2020	Clinical Reference Laboratory, Inc.	CRL Rapid Response	Molecular, Home Collection	H	HCP Patients EUA Summary IFU (Home Collect)
07/27/2020	Eli Lilly and Company	Lilly SARS-CoV-2 Assay	Molecular	H	HCP Patients EUA Summary
07/27/2020	Sandia National Laboratories	SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay	Molecular	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-Fluorescence Probing)	Molecular	H	HCP Patients IFU
07/23/2020	Helix OpCo LLC (dba Helix)	Helix COVID-19 Test	Molecular	H	HCP Patients EUA Summary
07/21/2020	DiaCarta, Inc.	QuantiVirus SARS-CoV-2 Multiplex Test Kit	Molecular	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	Molecular	H	HCP Patients EUA Summary
07/16/2020	Boston Heart Diagnostics	Boston Heart COVID-19 RT-PCR Test	Molecular	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	Molecular, 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	Molecular, 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	Molecular, 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	Molecular	H	HCP Patients IFU
07/13/2020	Trax Management Services Inc.	PhoenixDx SARS-CoV-2 Multiplex	Molecular	H	HCP Patients IFU
07/13/2020	Compass Laboratory Services, LLC	Compass Laboratory Services SARS-CoV2 Assay	Molecular, Home Collection	H	HCP Patients EUA Summary
07/10/2020	Boston Medical Center	BMC-CReM COVID-19 Test	Molecular	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	Molecular	H	HCP Patients EUA Summary
07/09/2020	BioSewoom, Inc.	Real-Q 2019-nCoV Detection Kit	Molecular	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	Molecular	H	HCP Patients EUA Summary
07/07/2020	Enzo Life Sciences, Inc.	AMPIPROBE SARS-CoV-2 Test System	Molecular	H	HCP Patients IFU
07/07/2020	Access Bio, Inc.	CareStart COVID-19 MDx RT-PCR	Molecular	H	HCP Patients IFU
07/07/2020	Gene By Gene	Gene By Gene SARS-CoV-2 Detection Test	Molecular	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	Molecular	H	HCP Patients EUA Summary
07/02/2020	Becton, Dickinson and Company (BD)	BD Veritor System for Rapid Detection of SARS-CoV-2	Antigen	H, M, W	HCP Patients IFU
07/02/2020	Centers for Disease Control and Prevention (CDC)	Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay	Molecular	H	HCP Patients IFU
07/01/2020	CENTOGENE US, LLC	CentoFast-SARS-CoV-2 RT-PCR Assay	Molecular	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	Molecular	H	HCP Patients EUA Summary
06/30/2020	TNS Co., Ltd (Bio TNS)	COVID-19 RT-PCR Peptide Nucleic Acid (PNA) Kit	Molecular	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	Molecular	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	Molecular	H	HCP Patients EUA Summary
06/25/2020	Diagnostic Solutions Laboratory, LLC	DSL COVID-19 Assay	Molecular	H	HCP Patients EUA Summary
06/25/2020	PreciGenome LLC	FastPlex Triplex SARS-CoV-2 Detection kit (RT-Digital PCR)	Molecular	H	HCP Patients IFU
06/25/2020	PlexBio Co., Ltd.	IntelliPlex SARS-CoV-2 Detection Kit	Molecular	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	Molecular	H	HCP Patients EUA Summary
06/23/2020	HealthQuest Esoterics	HealthQuest Esoterics TaqPath SARS-CoV-2 Assay	Molecular	H	HCP Patients EUA Summary
06/23/2020	University of Alabama at Birmingham Fungal Reference Lab	FRL SARS CoV-2 Test	Molecular	H	HCP Patients EUA Summary
06/23/2020	Gencurix, Inc.	GenePro SARS-CoV-2 Test	Molecular	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	Molecular	H	HCP Patients IFU
06/18/2020	3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.	TRUPCR SARS-CoV-2 Kit	Molecular	H	HCP Patients IFU
06/17/2020	The Ohio State University Wexner Medical Center	OSUWMC COVID-19 RT-PCR Test	Molecular	H	HCP Patients EUA Summary
06/17/2020	Omnipath-ology Solutions Medical Corporation	Omni COVID-19 Assay by RT-PCR	Molecular	H	HCP Patients EUA Summary
06/15/2020	Applied BioCode, Inc.	BioCode SARS-CoV-2 Assay	Molecular	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	Molecular	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	Molecular	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	Molecular	H	HCP Patients EUA Summary
06/10/2020	TBG Biotechnology Corp.	ExProbe SARS-CoV-2 Testing Kit	Molecular	H	HCP Patients IFU
06/10/2020	Cue Health Inc.	Cue COVID-19 Test	Molecular	H, W, M	HCP Patients IFU
06/09/2020	Illumina, Inc.	Illumina COVIDSeq Test	Molecular	H	HCP Patients IFU
06/09/2020	ChromaCode Inc.	HDPCR SARS-CoV-2 Assay	Molecular	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	Molecular	H	HCP Patients IFU
06/05/2020	Genetron Health (Beijing) Co., Ltd.	Genetron SARS-CoV-2 RNA Test	Molecular	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	Molecular	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	Molecular	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	Molecular	H	HCP Patients IFU-Home Collect EUA Summary
05/22/2020	dba SpectronRx	Hymon SARS-CoV-2 Test Kit	Molecular	H	HCP Patients IFU
05/21/2020	BioCore Co., Ltd.	BioCore 2019-nCoV Real Time PCR Kit	Molecular	H	HCP Patients IFU
05/21/2020	SolGent Co., Ltd.	DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit	Molecular	H	HCP Patients IFU
05/21/2020	Seasun Biomaterials, Inc.	AQ-TOP COVID-19 Rapid Detection Kit	Molecular	H	HCP Patients IFU
05/21/2020	P23 Labs, LLC.	P23 Labs TaqPath SARS-CoV-2 Assay	Molecular	H	HCP Patients IFU-Home Collect EUA Summary
05/18/2020	Quidel Corporation	Lyra Direct SARS-CoV-2 Assay	Molecular	H	HCP Patients IFU
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	Molecular	H	HCP Patients EUA Summary
05/15/2020	Assurance Scientific Laboratories	Assurance SARS-CoV-2 Panel	Molecular	H	HCP Patients EUA Summary
05/14/2020	Hologic, Inc.	Aptima SARS-CoV-2 assay	Molecular	H	HCP Patients IFU
05/14/2020	GeneMatrix, Inc.	NeoPlex COVID-19 Detection Kit	Molecular	H	HCP Patients IFU
05/13/2020	Applied DNA Sciences, Inc.	Linea COVID-19 Assay Kit	Molecular	H	HCP Patients IFU
05/11/2020	1drop Inc.	1copy COVID-19 qPCR Multi Kit	Molecular	H	HCP Patients IFU
05/11/2020	Abbott Molecular Inc.	Alinity m SARS-CoV-2 assay	Molecular	H, M	HCP Patients IFU
05/08/2020	Quidel Corporation	Sofia 2 SARS Antigen FIA	Antigen	H, M, W	HCP Patients IFU
05/08/2020	Gnomegen LLC	Gnomegen COVID-19-RT-qPCR Detection Kit	Molecular	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	Molecular	H	HCP Patients IFU Home Collect EUA Summary
05/07/2020	Zymo Research Corporation	Quick SARS-CoV-2rRT-PCR Kit	Molecular	H	HCP Patients IFU
05/06/2020	OPTI Medical Systems, Inc.	OPTI SARS-CoV-2 RT PCR Test	Molecular	H	HCP Patients IFU
05/06/2020	Sherlock BioSciences, Inc.	Sherlock CRISPR SARS-CoV-2 Kit	Molecular	H	HCP Patients IFU
05/06/2020	BioMérieux SA	SARS-COV-2 R-GENE	Molecular	H	HCP Patients IFU
05/05/2020	Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company)	FTD SARS-CoV-2	Molecular	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-Fluorescence Probing)	Molecular	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	Molecular	H	HCP Patients IFU
05/01/2020	BioFire Diagnostics, LLC	BioFire Respiratory Panel 2.1 (RP2.1)	Molecular	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	Molecular	H	HCP Patients IFU
04/29/2020	Rheonix, Inc.	Rheonix COVID-19 MDx Assay	Molecular	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	Molecular	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 Immunodiagnostic 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	Molecular	H	HCP Patients IFU
04/22/2020	altona Diagnostics GmbH	RealStar SARS-CoV02 RT-PCR Kits U.S.	Molecular	H	HCP Patients IFU
04/21/2020	Seegene, Inc.	Allplex 2019-nCoV Assay	Molecular	H	HCP Patients IFU
04/20/2020	Trax Management Services Inc.	PhoenixDx 2019-CoV	Molecular	H	HCP Patients IFU Letter Granting EUA Amendments (May 11, 2020)
04/18/2020	OSANG Healthcare	GeneFinder COVID-19 Plus RealAmp Kit	Molecular	H	HCP Patients IFU
04/17/2020	Fosun Pharma USA Inc.	Fosun COVID-19 RT-PCR Detection Kit	Molecular	H	HCP Patients IFU
04/16/2020	KorvaLabs Inc.	Curative-Korva SARS-Cov-2 Assay	Molecular	H	HCP Patients EUA Summary
04/16/2020	GenoSensor, LLC	GS™ COVID-19 RT-PCR KIT	Molecular	H	HCP Patients IFU
04/15/2020	Maccura Biotechnology (USA) LLC	SARS-CoV-2 Fluorescent PCR Kit	Molecular	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 Immunodiagnostic 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	Molecular	H	HCP Patients IFU
04/08/2020	DiaCarta, Inc.	QuantiVirus SARS-CoV-2 Test Kit	Molecular	H	HCP Patients IFU
04/08/2020	Becton, Dickinson & Company	BD SARS-CoV-2 Reagents for BD MAX System	Molecular	H, M	HCP Patients IFU
04/07/2020	InBios International, Inc.	Smart Detect SARS-CoV-2 rRT-PCR Kit	Molecular	H	HCP  Patients IFU
04/06/2020	Gnomegen LLC	Gnomegen COVID-19 RT-Digital PCR Detection Kit	Molecular	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	Molecular	H	HCP  Patients IFU
04/03/2020	ScienCell Research Laboratories	ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit	Molecular	H	HCP  Patients IFU
04/03/2020	Luminex Corporation	ARIES SARS-CoV-2 Assay	Molecular	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	Molecular	H, M	HCP  Patients  IFU
04/01/2020	Ipsum Diagnostics, LLC	COV-19 IDx Assay	Molecular	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	Molecular	H, M	HCP  Patients  IFU
03/30/2020	NeuMoDx Molecular, Inc.	NeuMoDx SARS-CoV-2 Assay	Molecular	H, M	HCP Patients IFU Letter Granting EUA Amendment(s) (April 23, 2020)
03/27/2020	Abbott Diagnostics Scarborough, Inc.	ID NOW COVID-19	Molecular	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	Molecular	H	HCP Patients IFU
03/26/2020	BGI Genomics Co. Ltd.	Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV	Molecular	H	HCP Patients IFU Letter Granting EUA Amendment(s) (April 24, 2020)
03/25/2020	Avellino Lab USA, Inc.	AvellinoCoV2 Test	Molecular	H	HCP Patients EUA Summary
03/24/2020	PerkinElmer, Inc.	PerkinElmer New Coronavirus Nucleic Acid Detection Kit	Molecular	H	HCP Patients IFU Letter Granting EUA Amendment(s) (April 1, 2020)
03/23/2020	Mesa Biotech Inc.	Accula SARS-Cov-2 Test	Molecular	H, M, W	HCP Patients IFU Letter Granting EUA Amendment(s) (April 30, 2020)
03/23/2020	BioFire Defense, LLC	BioFire COVID-19 Test	Molecular	H, M	HCP Patients IFU Letter Granting EUA Amendment(s) (April 30, 2020)
03/20/2020	Cepheid	Xpert Xpress SARS-CoV-2 Test	Molecular	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	Molecular	H	HCP Patients IFU Letter Granting EUA Amendment(s) (April 8, 2020)
03/19/2020	GenMark Diagnostics, Inc.	ePlex SARS-CoV-2 Test	Molecular	H, M	HCP Patients IFU
03/19/2020	DiaSorin Molecular LLC	Simplexa COVID-19 Direct Assay	Molecular	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	Molecular	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	Molecular	H	HCP Patients IFU Letter Granting EUA Amendment(s) (March 26, 2020)
03/17/2020	Quidel Corporation	Lyra SARS-CoV-2 Assay	Molecular	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	Molecular	H	HCP Patients EUASummary IFU-Home Collect Letter Granting EUA Amendment(s) (April 14, 2020)
03/16/2020	Hologic, Inc.	Panther Fusion SARS-CoV-2	Molecular	H	HCP Patients IFU Letter Granting EUA Amendment(s) (April 24, 2020)
03/13/2020	Thermo Fisher Scientific, Inc.	TaqPath COVID-19 Combo Kit	Molecular	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	Molecular	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	Molecular	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)	Molecular	H	HCP Patients IFU Letter Granting EUA Amendment(s) (March 30, 2020)

¹ Authorized settings include the following:

• H - authorized for use in Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
• M - authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity and moderate complexity tests.
• W - authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity and moderate complexity tests, and deemed to be CLIA waived for use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance.

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.


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 (46):

• 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
• 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
• BIONEER Corporation
• BioZentech Co., Ltd., BZ QPCR COVID-19 Kit
• ChromaCode, Inc. HDPCR SARS-CoV-2 Assay
• Co-Diagnostics, Inc. (FDA Authorized)
• Detectachem Inc., MD-Bio BCC19
• ELITechGroup MDx LLC SARS-CoV-2 ELITe MGB Assay
• Enzo Biochem, Inc Enzo AMPIPROBE® SARS-CoV-2 Test System
• Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay
• Gencurix Inc. GenePro SARS-CoV-2 Test
• GeneOne Diagnostics Corporation COVID-19 Nucleic Acid Diagnostic Kit
• GeneReach Biotechnology Corporation POCKIT Central SARS-CoV-2
• GenMark Diagnostics, Inc. ePlex Respiratory Pathogen Panel 2 (ePlex RP2 Panel)
• Genomictree, Inc. AccuraDTect SARS-CoV-2-qPCR Kit
• 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, Inc. Aptima SARS-CoV-2 Assay (FDA Authorized)
• Illucidx Inc., Illucidx COVID-19 Dx RT-LAMP
• LabGenomics, Co., Ltd. LabGun™ COVID-19 Assay Kit (FDA Authorized)
• MatMaCorp, MatMaCorp COVID-19 Test kit (used on the Solas 8)
• 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
• NovaTec Immundiagnosticsa GmBH GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR
• OPTOLANE Technologies Inc. Kaira 2019-nCoV Detection Kit
• OSANG Healthcare Co., Ltd, GeneFinder COVID-19 Plus RealAmp Kit (FDA Authorized)
• QIAGEN QIAstat-Dx Respiratory SARS-CoV-2 Panel Assay (FDA Authorized)
• RTA Labs DIAGNOVITAL SARS-CoV-2
• SA Scientific, SAS™ COVID-19 Antibody Detection Test
• SML GENETREE Co., Ltd. Ezplex SARS-CoV-2 G Kit
• Solgent Co. Ltd., COVID-19 DiaplexQ Diagnostic Kit (FDA Authorized)
• SUREDX V-CHEK Coronavirus (SARS-CoV-2) Antigen Detection Kit
• Suzhou PreciGenome, Ltd., Co., Fastplex Triplex SARS-CoV-2 Detection Kit (RT-PCR)
• T2Biosystems, Inc., T2SARS-CoV-2 Panel
• TAAG Genetics S.A. nPLEX SARS-CoV-2 Detection Kit
• Taigen Bioscience Corporation LabTurbo AIO COVID-19 RNA Testing Kit
• Vela Operations Singapore Pte Ltd. ViroKey SARS-CoV-2 RT-PCR Test v2.0
• VelaDx ViroKey™ SARS-CoV-2 RT-PCR Test
• YD Diagnostics Corp. MolecuTech Real-Time COVID-19
• ZhuHai Sinochips Bioscience Co., Ltd COVID-19 Real-time PCR Test Kit

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.
• Immufood, Inc. d/b/a Antibody19
• IMMYLabs
• KSL Diagnostics
• LabCorp Center for Esoteric Testing
• Mayo Clinic
• MEDNA Scientific, Inc.
• OneBlood, Inc.
• Otogenetics
• Phosphorus Diagnostics LLC
• 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 (184):

• Abbott Laboratories SARS-CoV-2 IgG (for use on ARCHITECT) (FDA Authorized)
• Accel Diagnostics, LLC Rapid C2T Total Ab (IgG/IgM) Card
• Access Bio, Inc. CareStart COVID-19 IgM/IgG
• AI DE Diagnostic Co., Ltd. SARS-CoV-2 IgG/IgM Antibody Test
• Akston Biosciences Corporation AntiCoV-ID IgG ELISA Test
• ALPCO SARS-CoV-2 IgG Chemiluminescence ELISA
• ALPCO SARS-CoV-2 IgG ELISA
• ALPCO SARS-CoV-2 IgM Chemiluminescence ELISA
• ALPCO SARS-CoV-2 IgM ELISA
• Alpha Pharma Service srl   IRIS SARS-CoV-2 IgG/IgM Rapid Test
• Ameda Labordiagnostik GmbH AMP Rapid Test SARS-CoV-2 IgG/IgM
• AngelWorld Biotech Manufacturing FZ LLC AngelWorld V2.0 COVID-19 IgG/IgM Antibody Rapid Test
• Ansh Labs SARS-CoV2 IgG ELISA (AL-1001)
• Ansh Labs SARS-CoV2 IgM ELISA (μ-Capture) (AL-1002)
• Antagen Pharmaceuticals, Inc. COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold)
• Antibody BioPharm, Inc. COVID-19 IgM/IgG POCT Kit (Colloidal Gold)
• Arbor Assays DetectX SARS-CoV-2 IgG ELISA Kit
• Asan Pharmaceutical Co., Ltd. Asan Easy Test COVID-19 IgG/IgM
• Assure Tech (Hangzhou) Co., Ltd.'s COVID-19 IgG/IgM Rapid Test Device (FDA Authorized)
• Aurora Biomed Inc. COVID-19 IgG/IgM Rapid Test Cassette (Colloidal Gold)
• Axium BioResearch, Inc. AxiumHealth COVID-19 IgG/IgM Antibody Test
• Beckman Coulter Access SARS-CoV-2 IgG test (Catalog No. C58961), Access SARS-CoV-2 IgG Calibrators (Catalog No. C58963) and Access SARS-CoV-2 IgG QC (Catalog No. C58964) (FDA Authorized)
• Beijing Beier Bioengineering Co., Ltd 2019-New Coronavirus IgG/IgM Rapid Test Cassette (WB/S/P)
• Beijing Diagreat Biotechnologies Co., Ltd. 2019-nCoV IgG Antibody Determination Kit
• Beijing Diagreat Biotechnologies Co., Ltd. 2019-nCoV IgM Antibody Determination Kit
• Beijing Diagreat Biotechnologies Co., Ltd. 2019-nCoV IgG/IgM Antibody Rapid Test Kit
• Beijing Kewei Clinical Diagnostic Reagent Inc. Genonto RapidTest10 COVID-19 IgG/IgM Antibody Rapid Test Kit
• Beijing O&D BIOTECH Co., LTD. Coronavirus disease(COVID-19) Total Antibody Rapid Test (Colloidal Gold)
• Beijing Wantai Biological Pharmaceutical Co., Ltd. TOTAL ANTIBODY WANTAI SARS- COV-2 Ab Rapid Test Kit
• Bethyl Laboratories, Inc. Bethyl SARS-CoV-2 IgG IVD ELISA
• Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test (Cassette Format)
• Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test (Strip Format)
• BioCheck, Inc. BioCheck SARS-CoV-2 IgM Antibody Test
• Biohit Healthcare (Hefei) Co., Ltd. SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method) (FDA Authorized)
• Biolidics Limited 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold)
• bioMérieux SA VIDAS® SARS-COV-2 IgG
• bioMérieux SA VIDAS® SARS-COV-2 IgM
• Bioscience(Tianjin) Diagnostic Technology Co., Ltd. Novel Coronavirus (2019-nCoV) Antibody Rapid Test
• Biosynex SA Biosynex COVID-19 BSS
• Boditech Med Inc AFIAS COVID-19 Ab serological tests
• Boston Bio Lab Inc. Boston Bio EZ Covid-19
• BTNX, Inc. Rapid Response™ COVID-19 IgG/IgM Test Cassette
• Chemtron Biotech, Inc. Chemtrue®Rapid COVID-19 IgM/IgG Antibody Test
• ClearSign Diagnostics Co Novel Coronavirus (SARS-CoV-2) Antibody (IgM/IgG) Test
• Core Technology Co., Ltd. CoreTest COVID-19 IgM/IgG Ab Test
• Core Technology Co., Ltd. RapidTest COVID-19 IgM/IgG Ab Test
• Coronacide™ COVID-19 IgM/IgG Rapid Test
• CTK Biotech, Inc. OnSite® COVID-19 IgG/IgM Rapid Test
• DIALAB(ZJG) Biotech Co., Ltd. Device Name: SARS-CoV-2 IgG/IgM Antibody Test (Fluorescence Immunoassay)
• DiaSorin Inc. LIAISON SARS-CoV-2 IgM
• Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit (FDA Authorized)
• Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-Cov-2 IgM CLIA Kit
• Dynamiker Biotechnology (Tianjin) Co., Ltd. RapidCOV™ 2019-nCOV IgG/IgM Rapid Test
• Eachy Biopharmaceuticals Co., Ltd. AccuRapid™ SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay)
• Eachy Biopharmaceuticals Co., Ltd. AccuRapid™ SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay)
• Eachy Biopharmaceuticals Co., Ltd. SmartScreen COVID-19 IgM/IgG Test Kit
• Enable Biosciences Inc. ADAP SARS-CoV-2 Total Antibody Assay
• EpiGentek SeroFlash SARS-CoV-2 IgM/IgG Antibody Detection Kit
• Epitope Diagnostics, Inc. EDI COVID-19 Nucleocapsid IgG Quantitative ELISA Kit Not FDA Authorized H
• Epitope Diagnostics, Inc. KT-1032 EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit
• Epitope Diagnostics, Inc. KT-1033 EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit
• ET Healthcare Inc. Pylon COVID-19 IgM/IgG Assay
• EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgA)
• EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgG) (FDA Authorized)
• Genelogic Research Limited Genelogic COVID-19 IgM/IgG Antibody Rapid Test
• GeneOne Diagnostics Corporation COVID-19 Nucleic Acid Diagnostic Kit
• GeneScan Diagnostics, LLC AmeriDx® SARS-CoV-2 IgG/IgM Rapid Test Kit
• GeneScan Diagnostics, LLC AmeriDx® SARS-CoV-2 IgG/IgM-T Antibody Rapid Test Kit
• Genesprint Group, Ltd. Genesprint Diagnostic Kit for IgG/IgM Antibody to SARS-CoV-2 Test
• Genrui Biotech Inc. Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold)
• Gold Standard Diagnostics INgezim® COVID 19 DR ELISA Test Kit
• Goldsite Diagnostics Inc SARS-CoV-2 IgG/IgM Kit
• Guangzhou Wondfo Biotech Co., Ltd. SARS-CoV-2 Antibody Test
• H&Z Life Science Co. Ltd. Anti-COVID-19 Virus IgM/IgG Test Kit (lateral flow assay)
• Hangzhou AllTest Biotech Co., Ltd. AllTest 2019-nCoV IgG/IgM Rapid Test Cassette
• Hangzhou AllTest Biotech Co., Ltd. AllTest COVID IgG/IgM Rapid Test Dipstick
• Hangzhou Biotest Biotech's COVID-19 IgG/IgM Rapid Test Cassette (FDA Authorized)
• Hangzhou Clongene Biotech Co., Ltd. Clungene COVID-19 IgM/IgG Rapid Test Cassette
• Hangzhou Realy Tech Co Ltd. 2019-nCOV IgG/IgM Rapid Test
• Hangzhou Sejoy Electronics & Instrument Co., Ltd. COVID-19 IgG/IgM Rapid Test Cassette
• Healgen Scientific, LLC. COVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma) (FDA Authorized)
• HUMASIS Co., Ltd. Humasis COVID-19 IgG/IgM Test
• INNOVITA (Tangshan) Biological Technology Co., Ltd. 2019-nCoV Ab Test (Colloidal Gold)
• Jiangsu Dablood Pharmaceutical Co, Ltd. AssuranceAB™ COVID-19 IgM/IgG Rapid Antibody Test
• Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. SARS-CoV-2 IgM/IgG Rapid Assay Kit (Colloidal Gold)
• Jiangsu Superbio Biomedical (Nanjing) Co., Ltd. SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)
• Jiangsu Superbio Biomedical (Nanjing) Co., Ltd. ThermoGenesis SARS-CoV-2(COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)
• Jiangsu Well Biotech Co., Ltd. COVID-19 IgM/IgG Rapid Test (Colloidal Gold)
• JOYSBIO (Tianjin) Biotechnology Co., Ltd. COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)
• Lifeassay Diagnostics (Pty) Ltd Test-it COVID-19 IgM/IgG Lateral Flow Assay
• LumiQuick Diagnostics, Inc., QuickProfile™ 2019-nCoV IgG/IgM Antibody Test
• Maccura Biotechnology Co., Ltd. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method
• MedicalSystem Biotechnology Co., Ltd. Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit
• MedMira Inc. REVEALCOVID-19™ Total Antibody Test
• Megna Health Inc. Megna Rapid COVID-19 IgG/IgM Combo Test Kit (FDA Authorized)
• Melbourne Biotech MB COVID-19 Antibody Detection Kit
• Micropoint Biosciences, Inc. mLabs® SARS-CoV-2 IgG and IgM Assay
• Mokobio Biotechnology R&D Center Inc COVID-19 IgM & IgG Rapid Test (Colloidal Gold Assay)
• Mokobio Biotechnology R&D Center SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay
• Multi-G bvba COVID-19 IgG/IgM Rapid Test Cassette
• Nanjing Liming Bio-products Co.,Ltd SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit
• Nanjing Norman Biological Technology Co., Ltd Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold)
• Nanjing SYNTHGENE Medical Technology Co., Ltd. SYNTHGENE COVID-19 IgM/IgG Rapid Detection Kit (Colloidal Gold Method)
• Nano-Ditech Corporation Nano-Check COVID-19 IgG/IgM Antibody Test
• NanoResearch, Inc. NanoMedicina™ SARS-COV-2 IgM/IgG Antibody Rapid Test
• Nantong Diagnos Biotechnology Co., Ltd. (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold)
• Naturitious LLC Viralert COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT
• NewScen Coast Bio-Pharmaceutical Co., Ltd. Covid-19 IgG/IgM Rapid Test
• NewScen Coast Bio-Pharmaceutical Co., Ltd. COVID-19 Microfluidic Combo Test
• Nirmidas Biotech, Inc. COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit
• Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold)
• Ortho Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack
• Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator (FDA Authorized)
• Pacific Connect Group LLC (US) SARS-CoV-2 IgG/IgM Rapid Test Kit
• PerGrande BioTech Development Co., Ltd. SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay)
• Pharmact GmbH, BelTEST It SARS CoV-2 IgM/IgG Rapid Test (Pharmact CoV-2 Rapid Test)
• Plexense, Inc. ACCEL ELISA COVID-19
• Promedical Equipment Pty Ltd Promedical IgM/IgG Rapid Detection Kit
• Promega Corporation Lumit™ Dx SARS-CoV-2 Immunoassay
• Prometheus Bio Inc. 2019-nCoV IgG/IgM Test (Whole blood/Serum/Plasma) Colloidal Gold
• ProteomeTech Inc. KOVIcheck COVID-19 IgG/IgM
• Qualigen, Inc. FastPack® SARS-CoV-2 IgG Immunoassay
• Qingdao Hightop Biotech Co., Ltd. HIGHTOP 2019-nCoV IgM/IgG Rapid Test
• Quansys Biosciences Q-Plex™ SARS-CoV-2 Human IgG (4-Plex)
• Quotient Suisse SA MosaiQ COVID-19 Antibody Magazine
• Reszon Diagnostics International Sdn. Bhd. RESZON (COVID-19) (Sars-Cov-2) IgG/IgM Antibody Test
• 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
• Salofa Oy Sienna™ COVID-19 IgG/IgM Rapid Test Cassette
• ScheBo® • Biotech AG ScheBo® • SARS-CoV-2 Quick
• Sciteck Diagnostics COVID19 Automated Antibody Assay
• Sensing Self Pte. Ltd. COVID-19 Rapid IgM/IgG Combined Antibody Assay Pre-Screening Kit<.li>
• Shandong ThinkLab Biotechnology Co., Ltd.: 2019-nCoV IgM/IgG antibody Test Kit (Colloidal-gold Assay)
• Shanghai Fosun Long March Medical Science Co., Ltd. Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit
• Shanghai Liangrun Biomedicine Technology Co., Ltd. Liangrun COVID-19 IgM/IgG Antibody Test
• Shenzhen Lvshiyuan Biotechnology Co., Ltd COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit
• Shenzhen Watmind Medical Co. SARS-CoV-2 IgG/IgM Ab Diagnostic Test Kit
• Shijiazhuang Hipro Biotechnology Co., Ltd. COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold)
• ShinJin Medics Inc. DIAKEY COVID-19 IgM/IgG Rapid Test
• Siemens Healthcare Diagnostics ADVIA Centaur SARS-CoV-2 Total (COV2T) (FDA Authorized)
• Siemens Healthcare Diagnostics Atellica IM SARS-CoV-2 Total (COV2T) (FDA Authorized)
• Siemens Healthcare Diagnostics Dimension EXL SARS-CoV-2 Total antibody Assay (COV2T) (FDA Authorized)
• Siemens Healthcare Diagnostics Dimension Vista SARS-CoV-2 Total Antibody Assay (COV2T) (FDA Authorized)
• Siemens Healthcare Diagnostics Inc. ADVIA Centaur® SARS-CoV-2 IgG (COV2G) (FDA Authorized)
• Siemens Healthcare Diagnostics Inc. Atellica® IM SARS-CoV-2 IgG (COV2G) (FDA Authorized)
• Singuway Biotech Inc. COVID-19 IgG/IgM Detection Kit (Colloidal Gold)
• Sinocare, Inc. SARS-CoV-2 Antibody Test Kit (Colloidal Gold Method)
• Sober Holdings, LLC COVID-19 IgG/IgM Rapid Test Kit (Whole Blood/Serum/Plasma)
• Spring Health Care AG COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
• Sunbeam Laboratories, LLC. Sunbeam Laboratories Covid-19 Rapid Test Kit
• SUREDX V-CHEK™ SARS-CoV-2 Antibody Rapid Test Kit
• TBG Biotechnology Corp. SARS-CoV-2 IgG / IgM Rapid Test Kit
• Telepoint Medical Services SARS-CoV-2 IgG/IgM Rapid Qualitative Test
• Tetracore Inc. Tetracore FlexImmArray SARS-CoV-2 Human IgG Test
• Tianjin New Bay Bioresearch Co., Ltd. Quikpac II COVID-19 IgG/IgM
• Türklab Tibbi Malzemeler San. ve Tic. A.Ş. INFO SARS-CoV-2 IgM/IgG Ab Test
• Türklab Tibbi Malzemeler San. ve Tic. A.Ş. TOYO SARS-CoV-2 IgM/IgG Ab Test
• UC Berkeley Innovative Genomic Institute
• United Biomedical, Inc. UBI® SARS-CoV-2 ELISA
• VicTorch Meditek Inc. COVID-19 IgG/IgM Rapid test Cassette
• VicTorch Meditek Inc.  COVID-19 Serology IgG ELISA
• VicTorch Meditek Inc.  COVID-19 Serology IgM ELISA
• VirIntel, LLC VirIntel COVID-19 Antibody Test
• Virotech Diagnostics GmbH Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit
• Virotech Diagnostics GmbH Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit
• Vitro Diagnostics Vitro Diagnostics COVID 19 IgG/IgM Rapid Test Cassette Serology Device
• VivaChek Biotech (Hangzhou) Co., Ltd. VivaDiag COVID-19 IgM/IgG Rapid Test
• Vivera Pharmaceuticals, Inc. COVx-RT
• Vivera Pharmaceuticals, Inc. Vivera Pharma COVID-19 Rapid Test
• Wuhan UNscience Biotechnology Co., Ltd. Coronavirus-19 (COVID-19) Antibody (IgM/IgG) Rapid Test Kit (Colloidal gold immunochromatography)
• Wuhu 3H Biotechnology Co. Ltd. COVID-19 IgG/IgM Test Kit (Colloidal Gold Method)
• Xiamen AmonMed Biotechnology Co., Ltd. COVID-19 IgM/IgG test kit (Colloidal Gold)
• Xiamen Biotime Biotechnology Co., Ltd. Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test
• Xiamen Wiz Biotech Co., Ltd. Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2
• Zalgen Labs, LLC. ReSARS CoV-2 (N) IgG ELISA
• ZEUS Scientific, Inc. ELISA SARS-CoV-2 IgG Test System
• ZEUS Scientific, Inc. ZEUS ELISA SARS-CoV-2 Total Antibody Test System
• Zhejiang GENE SCIENCE Co., Ltd Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit (Latex Chromatography)
• Zhejiang Orient Gene Biotech, Co., Ltd. COVID-19 IgG/IgM Rapid Test Cassette
• Zhuhai Keyu Biological Engineering Co., Ltd. SARS-CoV-2 IgG/IgM Rapid Test Kit
• Zybio Inc. SARS-CoV-2 IgM/IgG Antibody Assay Kit (Colloidal Gold Method)

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