Friday, April 3, 2020

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.

Tuesday, March 24, 2020

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

As of September 20, 2020, there are 214 in vitro diagnostic EUAs (163 molecular, 4 antigen, 46 serology, 1 COVID-19 management IVD) and 183 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

09/16/2020
Visby Medical, Inc.
RT-PCR
H, M
09/14/2020
Roche Molecular Systems, Inc.
Real-time RT-PCR, Multi-analyte
H, M, W
09/14/2020
Shenzhen New Industries Biomedical Engineering Co., Ltd.
IgM and IgG, CLIA
H, M
09/09/2020
BioCheck, Inc.
IgM, CLIA
H, M
09/09/2020
BioCheck, Inc.
IgG, CLIA
H, M
09/09/2020
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Real-time RT-PCR
H
09/08/2020
Verily Life Sciences
Real-time RT-PCR, Pooling
H
09/04/2020
BillionToOne, Inc.
Sequencing
H
09/03/2020
Sugentech, Inc.
IgG, Lateral Flow
H, M
09/03/2020
Roche Molecular Systems, Inc.
Real-time RT-PCR, Multi-analyte
H, M
09/02/2020
Real-time RT-PCR
Molecular
H
09/01/2020
Detectachem Inc.
RT-LAMP
H
09/01/2020
OPTOLANE Technologies, Inc.
Real-time RT-PCR
H
08/31/2020
TBG Biotechnology Corp.
IgM and IgG, Lateral Flow
H, M
08/31/2020
University of Arizona Genetics Core for Clinical Services
Total Antibody, ELISA
H
08/31/2020
T2 Biosystems, Inc.
RT, amplification, T2 Magnetic resonance
H
08/31/2020
MiraDx
Real-time RT-PCR
H
08/31/2020
Mammoth Biosciences, Inc.
RT-LAMP, CRISPR
H
08/31/2020
BayCare Laboratories, LLC
Real-time RT-PCR, Pooling
H
08/31/2020
Color Genomics, Inc.
Home Collection Kit
08/28/2020
Patients Choice Laboratories, LLC
Real-time RT-PCR
H
08/28/2020
DxTerity Diagnostics, Inc.
Real-time RT-PCR, Home Collection, Screening, Saliva
H
08/26/2020
Cuur Diagnostics
Real-time RT-PCR
H
08/26/2020
Abbott Diagnostics Scarborough, Inc.
Antigen Lateral Flow, Visual Read
H, M, W
08/25/2020
Biocan Diagnostics Inc.
IgM and IgG, Lateral Flow
H, M
08/25/2020
Fluidigm Corporation
Real-time RT-PCR, Saliva
H
08/25/2020
QDx Pathology Services
Real-time RT-PCR, Home Collection
H
08/21/2020
Guardant Health, Inc.
Sequencing
H
08/21/2020
DxTerity Diagnostics, Inc.
Real-time RT-PCR, Saliva
H
08/21/2020
Texas Department of State Health Services, Laboratory Services Section
Real-time RT-PCR
H
08/18/2020
LumiraDx UK Ltd.
Antigen Microfluidic Immunofluorescence Assay, Instrument Read
H, M, W
08/17/2020
BioCheck, Inc.
IgM and IgG, CLIA
H, M
08/17/2020
Diazyme Laboratories, Inc.
IgM, CLIA
H, M
08/17/2020
ZhuHai Sinochips Bioscience Co., Ltd.
Real-time RT-PCR
H
08/15/2020
Yale School of Public Health, Department of Epidemiology of Microbial Diseases
Real-time RT-PCR, Saliva
H
08/13/2020
Pro-Lab Diagnostics
RT, Isothermal amplification
H
08/11/2020
Biomeme, Inc.
Real-time RT-PCR
H
08/11/2020
LumiraDx UK Ltd.
RT, non-isothermal nucleic acid amplification qSTAR
H
08/10/2020
Solaris Diagnostics
Real-time RT-PCR
H
08/10/2020
Alpha Genomix Laboratories
Real-time RT-PCR
H
08/07/2020
George Washington University Public Health Laboratory
Real-time RT-PCR
H
08/06/2020
bioMérieux SA
IgM, ELFA
H, M
08/06/2020
bioMérieux SA
IgG, ELFA
H, M
08/06/2020
Helix OpCo LLC (dba Helix)
Sequencing
H
08/05/2020
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Total Antibody, ELISA
H
08/05/2020
Vela Operations Singapore Pte Ltd.
Real-time RT-PCR
H
08/03/2020
ISPM Labs, LLC dba Capstone Healthcare
Real-time RT-PCR
H
08/03/2020
Wren Laboratories LLC
Real-time RT-PCR
H
08/03/2020
Ethos Laboratories
RT-PCR and MALDI-TOF Mass Spec.
H
08/03/2020
Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute
Real-time RT-PCR
H
08/03/2020
Poplar Healthcare
TMA, chemiluminescent, Pooling
H
07/31/2020
Siemens Healthcare Diagnostics Inc.
IgG, Semi-quantitative
H, M
07/31/2020
Siemens Healthcare Diagnostics Inc.
IgG, Semi-quantitative
H, M
07/31/2020
Xiamen Zeesan Biotech Co., Ltd.
Real-time RT-PCR
H
07/31/2020
University of California San Diego Health
Real-time RT-PCR, Pooling
H
07/30/2020
Clinical Reference Laboratory, Inc.
Real-time RT-PCR, Home Collection, Saliva
H
07/27/2020
Eli Lilly and Company
Real-time RT-PCR
H
07/27/2020
Sandia National Laboratories
Real-time RT-PCR
H
07/24/2020
Xiamen Biotime Biotechnology Co., Ltd.
IgM and IgG, Lateral Flow
H, M
07/24/2020
Access Bio, Inc.
IgM and IgG, Lateral Flow
H, M
07/24/2020
Jiangsu CoWin Biotech Co., Ltd.
Real-time RT-PCR
H
07/23/2020
Helix OpCo LLC (dba Helix)
Real-time RT-PCR
H
07/21/2020
DiaCarta, Inc.
Real-time RT-PCR
H
07/17/2020
Megna Health, Inc.
IgM and IgG, Lateral Flow
H, M
07/17/2020
Access Genetics, LLC
Real-time RT-PCR
H
07/16/2020
Boston Heart Diagnostics
Real-time RT-PCR
H
07/16/2020
Luminex Corporation
IgG, FMIA
H
07/15/2020
Quest Diagnostics Infectious Disease, Inc.
Real-time RT-PCR, Home Collection
H
07/15/2020
Quest Diagnostics Infectious Disease, Inc.
Real-time RT-PCR, Home Collection
H
07/15/2020
Quest Diagnostics Infectious Disease, Inc.
TMA, chemiluminescent, Home Collection
H
07/13/2020
Salofa Oy
IgM and IgG, Lateral Flow
H, M
07/13/2020
KogeneBiotech Co., Ltd.
Real-time RT-PCR
H
07/13/2020
Trax Management Services Inc.
Real-time RT-PCR
H
07/13/2020
Compass Laboratory Services, LLC
Real-time RT-PCR, Home Collection
H
07/10/2020
Boston Medical Center
Real-time RT-PCR
H
07/10/2020
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd
Total Antibody, Lateral Flow
H, M
07/09/2020
UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin
RT-LAMP
H
07/09/2020
BioSewoom, Inc.
Real-time RT-PCR
H
07/08/2020
Diazyme Laboratories, Inc.
IgG, CLIA
H, M
07/08/2020
Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard
Real-time RT-PCR
H
07/07/2020
Enzo Life Sciences, Inc.
Real-time RT-PCR
H
07/07/2020
Access Bio, Inc.
Real-time RT-PCR
H
07/07/2020
Gene By Gene
Real-time RT-PCR
H
07/06/2020
Assure Tech. (Hangzhou Co., Ltd)
IgM and IgG, Lateral Flow
H, M
07/06/2020
Laboratorio Clinico Toledo
Real-time RT-PCR
H
07/02/2020
Becton, Dickinson and Company (BD)
Antigen Chromatographic Digital Immunoassay, Instrument Read
H, M, W
07/02/2020
Centers for Disease Control and Prevention (CDC)
Real-time RT-PCR, Multi-analyte
H
07/01/2020
CENTOGENE US, LLC
Real-time RT-PCR
H
06/30/2020
InBios International, Inc.
IgM, ELISA
H
06/30/2020
Psomagen, Inc.
Real-time RT-PCR
H
06/30/2020
TNS Co., Ltd (Bio TNS)
RT-PCR
H
06/30/2020
The Kroger Co.
Home Collection Kit
06/29/2020
LifeHope Labs
Real-time RT-PCR
H
06/29/2020
Acupath Laboratories, Inc.
Real-time RT-PCR
H
06/26/2020
Beckman Coulter, Inc.
IgG , CLIA
H, M
06/26/2020
Inform Diagnostics, Inc.
Real-time RT-PCR
H
06/25/2020
Diagnostic Solutions Laboratory, LLC
Real-time RT-PCR
H
06/25/2020
PreciGenome LLC
RT-digital droplet PCR
H
06/25/2020
PlexBio Co., Ltd.
RT-PCR
H
06/24/2020
University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory
Real-time RT-PCR
H
06/23/2020
HealthQuest Esoterics
Real-time RT-PCR
H
06/23/2020
University of Alabama at Birmingham Fungal Reference Lab
Real-time RT-PCR
H
06/23/2020
Gencurix, Inc.
Real-time RT-PCR
H
06/23/2020
Babson Diagnostics, Inc.
IgG , CLIA
H
06/19/2020
Hangzhou Laihe Biotech Co., Ltd.
IgM and IgG Lateral Flow
H, M
06/18/2020
Biohit Healthcare (Hefei) Co. Ltd.
IgM and IgG Lateral Flow
H, M
06/18/2020
Jiangsu Bioperfectus Technologies Co., Ltd.
Real-time RT-PCR
H
06/18/2020
3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.
Real-time RT-PCR
H
06/17/2020
The Ohio State University Wexner Medical Center
Real-time RT-PCR
H
06/17/2020
Omnipath-ology Solutions Medical Corporation
Real-time RT-PCR
H
06/15/2020
Applied BioCode, Inc.
RT-PCR
H
06/15/2020
Emory Medical Laboratories
Serology IgG
H
06/13/2020
Kaiser Permanente Mid-Atlantic States
Real-time RT-PCR, Home Collection, Screening
H
06/12/2020
RTA Laboratories Biological Products Pharma-ceutical and Machinery Industry
Real-time RT-PCR
H
06/10/2020
InBios International, Inc.
Serology IgG
H
06/10/2020
Tide Laboratories, LLC
Real-time RT-PCR
H
06/10/2020
TBG Biotechnology Corp.
Real-time RT-PCR
H
06/10/2020
Cue Health Inc.
RT, Isothermal amplification
H, W, M
06/09/2020
Illumina, Inc.
Sequencing
H
06/09/2020
ChromaCode Inc.
Real-time RT-PCR
H
06/08/2020
Siemens Healthcare Diagnostics Inc.
Total Antibody
H, M
06/08/2020
Euroimmun US Inc.
Real-time RT-PCR
H
06/05/2020
Genetron Health (Beijing) Co., Ltd.
Real-time RT-PCR
H
06/04/2020
Vibrant America Clinical Labs
Serology IgM and IgG
H
06/04/2020
Phosphorus Diagnostics LLC
Real-time RT-PCR, Home Collection, Saliva
H
06/04/2020
Hangzhou Biotest Biotech Co., Ltd.
Serology IgM and IgG
H
06/02/2020
Roche Diagnostics
Immuno-assay IL-6
H, M
06/01/2020
Gravity Diagnostics, LLC
Real-time RT-PCR, Home Collection
H
05/29/2020
Healgen Scientific LLC
Serology IgM and IgG
H, M
05/29/2020
Siemens Healthcare Diagnostics Inc.
Total Antibody
H, M
05/29/2020
Siemens Healthcare Diagnostics Inc.
Total Antibody
H, M
05/28/2020
PrivaPath Diagnostics, Inc.
TMA, chemiluminescent, Home Collection
H
05/22/2020
dba SpectronRx
Real-time RT-PCR
H
05/22/2020
Exact Sciences Laboratories
Real-time RT-PCR, Home Collection
H
05/21/2020
BioCore Co., Ltd.
Real-time RT-PCR
H
05/21/2020
SolGent Co., Ltd.
Real-time RT-PCR
H
05/21/2020
Seasun Biomaterials, Inc.
RT-LAMP
H
05/21/2020
P23 Labs, LLC.
Real-time RT-PCR, Home Collection, Saliva
H
05/18/2020
Quidel Corporation
Real-time RT-PCR
H
05/18/2020
Color Genomics, Inc.
RT, LAMP, Home Collection
H
05/15/2020
Everlywell, Inc.
Home Collection Kit
N/A
05/15/2020
Fulgent Therapeutics, LLC
Real-time RT-PCR, Home Collection
H
05/15/2020
Assurance Scientific Laboratories
Real-time RT-PCR, Home Collection
H
05/14/2020
Hologic, Inc.
TMA, chemiluminescent
H
05/14/2020
GeneMatrix, Inc.
Real-time RT-PCR
H
05/13/2020
Applied DNA Sciences, Inc.
Real-time RT-PCR
H
05/11/2020
1drop Inc.
Real-time RT-PCR
H
05/11/2020
Abbott Molecular Inc.
Real-time RT-PCR
H, M
05/08/2020
Quidel Corporation
Antigen Lateral Flow, Fluorescence, Instrument Read
H, M, W
05/08/2020
Gnomegen LLC
Real-time RT-PCR
H
05/07/2020
Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics - Rutgers University
Real-time RT-PCR, Home Collection, Saliva
H
05/07/2020
Zymo Research Corporation
Real-time RT-PCR
H
05/06/2020
OPTI Medical Systems, Inc.
Real-time RT-PCR
H
05/06/2020
Sherlock BioSciences, Inc.
RT-LAMP, CRISPR
H
05/06/2020
BioMérieux SA
Real-time RT-PCR
H
05/05/2020
Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company)
Real-time RT-PCR
H
05/04/2020
EUROIMMUN US Inc.
Serology IgG
H
05/04/2020
Sansure BioTech Inc.
Real-time RT-PCR
H
05/02/2020
Roche Diagnostics
Serology Antibody
H, M
05/01/2020
Bio-Rad Laboratories, Inc.
RT-droplet PCR
H
05/01/2020
BioFire Diagnostics, LLC
RT, Nested multiplex PCR, Multi-analyte
H, M
04/30/2020
Wadsworth Center, New York State Department of Health
Serology Total Antibody
H
04/29/2020
LabGenomics Co., Ltd.
Real-time RT-PCR
H
04/29/2020
Rheonix, Inc.
RT-PCR
H
04/29/2020
Bio-Rad Laboratories
Serology Total Antibody
H
04/27/2020
Seasun Biomaterials
Real-time RT-PCR
H
04/26/2020
Abbott Laboratories Inc.
Serology IgG only
H, M
04/24/2020
DiaSorin Inc.
Serology IgG only
H, M
04/24/2020
Ortho-Clinical Diagnostics, Inc.
Serology IgG only
H, M
04/24/2020
Autobio Diagnostics Co. Ltd.
Serology IgM and IgG
H, M
04/23/2020
SD Biosensor, Inc.
Real-time RT-PCR
H
04/22/2020
altona Diagnostics GmbH
Real-time RT-PCR
H
04/21/2020
Seegene, Inc.
Real-time RT-PCR
H
04/20/2020
Trax Management Services Inc.
Real-time RT-PCR
H
04/18/2020
OSANG Healthcare
Real-time RT-PCR
H
04/17/2020
Fosun Pharma USA Inc.
Real-time RT-PCR
H
04/16/2020
KorvaLabs Inc.
Real-time RT-PCR
H
04/16/2020
GenoSensor, LLC
Real-time RT-PCR
H
04/15/2020
Maccura Biotechnology (USA) LLC
Real-time RT-PCR
H
04/15/2020
Mount Sinai Laboratory
Serology IgG
H
04/14/2020
Ortho Clinical Diagnostics, Inc.
Serology Total Antibody
H, M
04/10/2020
Atila BioSystems, Inc.
RT, Isothermal amplification
H
04/08/2020
DiaCarta, Inc.
Real-time RT-PCR
H

04/08/2020
Becton, Dickinson & Company
Real-time RT-PCR
H, M

04/07/2020
InBios International, Inc.
Real-time RT-PCR
H

04/06/2020
Gnomegen LLC
Real-time RT-digital PCR
H

04/03/2020
Co-Diagnostics, Inc.
RT-PCR, CoPrimer technology
H

04/03/2020
ScienCell Research Laboratories
Real-time RT-PCR
H

04/03/2020
Luminex Corporation
RT-PCR
H, M

04/02/2020
Becton, Dickinson & Company (BD)
Real-time RT-PCR
H, M

04/01/2020
Ipsum Diagnostics, LLC
Real-time RT-PCR
H

04/01/2020
Cellex Inc.
Serology IgM and IgG
H, M

03/30/2020
QIAGEN GmbH
Real-time RT-PCR, Multi-analyte
H, M

03/30/2020
NeuMoDx Molecular, Inc.
RT-PCR
H, M

03/27/2020
Abbott Diagnostics Scarborough, Inc.
RT, Isothermal amplification
H, M, W

03/27/2020
Luminex Molecular Diagnostics, Inc.
RT-PCR
H

03/26/2020
BGI Genomics Co. Ltd.
Real-time RT-PCR
H

03/25/2020
Avellino Lab USA, Inc.
Real-time RT-PCR
H

03/24/2020
PerkinElmer, Inc.
Real-time RT-PCR
H

03/23/2020
Mesa Biotech Inc.
RT and amplification
H, M, W

03/23/2020
BioFire Defense, LLC
RT, Nested multiplex PCR
H, M

03/20/2020
Cepheid
Real-time RT-PCR
H, M, W

03/20/2020
Primerdesign Ltd.
Real-time RT-PCR
H

03/19/2020
GenMark Diagnostics, Inc.
RT-PCR and electrochemical detection
H, M

03/19/2020
DiaSorin Molecular LLC
Real-time RT-PCR
H, M

03/18/2020
Abbott Molecular
Real-time RT-PCR
H

03/17/2020
Quest Diagnostics Infectious Disease, Inc.
Real-time RT-PCR, Home Collection, Pooling
H

03/17/2020
Quidel Corporation
Real-time RT-PCR
H

03/16/2020
Laboratory Corporation of America (LabCorp)
Real-time RT-PCR, Home Collection, Pooling, Screening
H

03/16/2020
Hologic, Inc.
Real-time RT-PCR
H

03/13/2020
Thermo Fisher Scientific, Inc.
Real-time RT-PCR
H

03/12/2020
Roche Molecular Systems, Inc. (RMS)
Real-time RT-PCR
H, M

02/29/2020
Wadsworth Center, New York State Department of Public Health's (CDC)
Real-time RT-PCR
H

02/04/2020
Centers for Disease Control and Prevention's (CDC)
Real-time RT-PCR
H



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 (61):

  • 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
  • BIONEER Corporation
  • BioZentech Co., Ltd., BZ QPCR COVID-19 Kit
  • ChromaCode, Inc. HDPCR SARS-CoV-2 Assay
  • Clinomics USA Inc., TrioDx RT-PCR COVID-19 Test
  • Co-Diagnostics, Inc. (FDA Authorized)
  • Detectachem Inc., MD-Bio BCC19
  • 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
  • Eryigit medical Devices, Sentebiolab Senteligo SARS CoV-2 (COVID-19) Multiplex qPCR Detection Kit
  • Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay
  • Gencurix Inc. GenePro SARS-CoV-2 Test (FDA Authorized)
  • GeneOne Diagnostics Corporation COVID-19 Nucleic Acid Diagnostic Kit
  • GeneReach Biotechnology Corporation POCKIT Central SARS-CoV-2
  • 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)
  • 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
  • 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
  • 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)
  • 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
  • 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
  • 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
  • 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

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 (28):

  • 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
  • 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 (183):

  • Abbott Laboratories SARS-CoV-2 IgG (for use on ARCHITECT) (FDA Authorized)
  • 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
  • AdvanSure™ SARS-CoV-2 IgG (S1) ELISA
  • AESKU.DIAGNOSTICS GmbH & Co. KG AESKULISA® SARS-CoV-2 NP IgG
  • AESKU.DIAGNOSTICS GmbH & Co. KG AESKULISA® SARS-Co
  • 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
  • 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)
  • AnyGo Technology Co., Ltd: COVID-19 Capture ELISA Assay
  • Assure Tech (Hangzhou) Co., Ltd.'s COVID-19 IgG/IgM Rapid Test Device (FDA Authorized)
  • Beckman Coulter Access SARS-CoV-2 IgG Test, Access SARS-CoV-2 IgG Calibrators and Access SARS-CoV-2 IgG QC (FDA Authorized)
  • Beckman Coulter, Inc. Access SARS-CoV-2 IgM test, Access SARS-CoV-2 IgM Calibrators, and Access SARS-CoV-2 IgM QC
  • Beijing Beier Bioengineering Co., Ltd 2019-New Coronavirus IgG/IgM Rapid Test Cassette (WB/S/P)
  • 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 (FDA Authorized)
  • 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) (FDA Authorized)
  • 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 (FDA Authorized)
  • Biohit Healthcare (Hefei) Co., Ltd. SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method) (FDA Authorized)
  • Biomerica, Inc. COVID-19 IgG ELISA Test
  • bioMérieux SA VIDAS® SARS-COV-2 IgG (FDA Authorized)
  • bioMérieux SA VIDAS® SARS-COV-2 IgM (FDA Authorized)
  • Bioscience(Tianjin) Diagnostic Technology Co., Ltd. Novel Coronavirus (2019-nCoV) Antibody Rapid Test
  • Biosynex SA Biosynex COVID-19 BSS
  • 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
  • BreviTest Technologies, LLC Brevitest IgG Plasma/Serum Serology Test for SARS-CoV-2
  • BTNX, Inc. Rapid Response™ COVID-19 IgG/IgM Test Cassette
  • CareHealth America Corporation CoviCheck™ COVID-19 IgM/IgG Antibody Test
  • Cell ID Pte Ltd Smart COVID-19 IgM/IgG Rapid Diagnostic Test (RDT)
  • ClearSign Diagnostics Co Novel Coronavirus (SARS-CoV-2) Antibody (IgM/IgG) Test
  • ClearSign Diagnostics Co., LLC ClearSign Diagnostics SARS-CoV-2 Antibody (IgM and IgG) Test
  • Core Technology Co., Ltd. CoreTest COVID-19 IgM/IgG Ab Test
  • Core Technology Co., Ltd. RapidTest COVID-19 IgM/IgG Ab Test
  • CoreMedica Laboratories, Inc. Capillary Blood Collection Kit & Laboratory Analysis for SARS-CoV-2 ELISA IgG and IgM
  • CTK Biotech, Inc. OnSite® COVID-19 IgG/IgM Rapid Test
  • Diabetomics, Inc CovAbScreen™ SARS-CoV-2 Ab 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 (FDA Authorized)
  • 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)
  • Excelsior Bio-System, Inc. EBSALERT SARS-CoV-2 Antibody Rapid test
  • Freedom For All Diagnostics™, Inc SARS-CoV-2 IgM/IgG Antibody Assay Kit
  • 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
  • Genrui Biotech Inc. Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold)
  • Gold Standard Diagnostics INgezim® COVID 19 CROM Rapid Test Kit
  • 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)
  • Horizon Pharmaceuticals, Inc. Horizon RDT SARS CoV-2 IgM/IgG Antibody Test
  • 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 Well Biotech Co., Ltd. COVID-19 IgM/IgG Rapid Test (Colloidal Gold)
  • LG Chem, Ltd., AdvanSure™ SARS-CoV-2 IgG(S1) ELISA
  • Liming BioProducts Co. Ltd. SARS-CoV-2 lgM/lgG Antibody Rapid Test
  • Maccura Biotechnology Co., Ltd. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method
  • MBio Diagnostics, Inc. LightDeck® COVID-19 Total Antibody Test
  • MedMira Inc. REVEALCOVID-19™ Total Antibody Test
  • Megna Health Inc. Megna Rapid COVID-19 IgG/IgM Combo Test Kit (FDA Authorized)
  • 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
  • Molecular Innovations SARS-CoV-2 IgG Seroconversion ELISA Kit
  • Monarch Global Health LLC Magellan IgM and IgG Antibody Rapid Test Kit for Serum
  • 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)
  • Nanjing Weiyun Biotechnology Co., Ltd. SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)
  • NanoResearch, Inc. NanoMedicina™ SARS-COV-2 IgM/IgG Antibody Rapid Test
  • Nantong Diagnos Biotechnology Co., Ltd. (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold)
  • 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
  • Nirmidas Biotech, Inc. MidaSpot™ COVID-19 Antibody Combo Detection Kit
  • Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold)
  • Oncosem Onkolojik Sistemler San.ve Tic. A.S CRT (COVID-19 Rapid Test)
  • 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)
  • Pharmact GmbH, BelTEST It SARS CoV-2 IgM/IgG Rapid Test (Pharmact CoV-2 Rapid Test)
  • Plexense, Inc. ACCEL ELISA COVID-19
  • Profarma, UAB ProRapid Coronavirus Disease (SARS-CoV-2) IgG/IgM Rapid Test Cassette Single Use Kit
  • ProGnosis Biotech SA Bio-Shield 2019-nCoV Total Ig ELISA
  • ProGnosis Biotech SA Rapid Test 2019-nCoV Total Ig S
  • 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
  • Qiagen GmbH Access Anti-SARS-CoV-2 Total Test
  • Qingdao Hightop Biotech Co., Ltd. HIGHTOP 2019-nCoV IgM/IgG Rapid Test
  • Qualigen, Inc. FastPack® SARS-CoV-2 IgG Immunoassay
  • Quansys Biosciences Q-Plex™ SARS-CoV-2 Human IgG (4-Plex)
  • Quanterix Simoa Quantitative SARS-CoV-2 IgG Antibody Test
  • Quotient Suisse SA MosaiQ COVID-19 Antibody Magazine
  • 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 (FDA Authorized)
  • 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 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
  • 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)
  • 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 (FDA Authorized)
  • Tetracore Inc. Tetracore FlexImmArray SARS-CoV-2 Human IgG Test
  • TheraTest Laboratories, Inc. EL-Anti-SARS-CoV-2 IgG
  • 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
  • Victory Square Health Canada, Inc. Safetest-COVID19 IgG / IgM - Elisa Kit
  • 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
  • VivaChek Biotech (Hangzhou) Co., Ltd. VivaDiag COVID-19 IgM/IgG Rapid Test
  • Vivera Pharmaceuticals, Inc. COVx-RT
  • Wuhan UNscience Biotechnology Co., Ltd. Coronavirus-19 (COVID-19) Antibody (IgM/IgG) Rapid Test Kit (Colloidal gold immunochromatography)
  • 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
  • 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
  • Zybio Inc. SARS-CoV-2 IgM/IgG Antibody Assay Kit (Colloidal Gold Method)