Friday, April 3, 2020

New 2-Day Online Rapid Microbiological Methods Master Class - May 20-21, 2020

Due to an overwhelming request to repeat my online 2-Day Rapid Microbiological Methods Master Class, I have scheduled a new class for May 20 and 21, 2020. This will be a live event where you will learn about the current regulatory policies for implementation and submissions, the scientific principles for commercially-available rapid technologies, a comprehensive, step-by-step strategy for validation, rapid sterility testing for ATMPs (cell therapy), case studies on statistical analyses 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-may2020.php.

Tuesday, March 24, 2020

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

As of May 27, 2020, there are 81 in vitro diagnostic (molecular, serology, home collection) EUAs and 191 validated serology or serum / plasma / whole blood tests (these do not have 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 EUA and FAQs on Testing for SARS-CoV-2 websites. 

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.

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. NOTE: the table should be viewed in landscape mode on smaller handheld devices.

Date EUA Issued
Manufacturer
Letter of Authorization
Technology
Authorized Settings1
Authorization Documents2

05/22/2020
dba SpectronRx
Molecular
H
05/21/2020
BioCore Co., Ltd.
Molecular
H
05/21/2020
SolGent Co., Ltd.
Molecular
H
05/21/2020
Seasun Biomaterials, Inc.
Molecular
H
05/21/2020
P23 Labs, LLC.
Molecular
H
05/18/2020
Quidel Corporation
Molecular
H
05/15/2020
Everlywell, Inc.
Home Collection Kit
N/A
05/15/2020
Fulgent Therapeutics, LLC
Molecular
H
05/15/2020
Assurance Scientific Laboratories
Molecular
H
05/14/2020
Hologic, Inc.
Molecular
H
05/14/2020
GeneMatrix, Inc.
Molecular
H
05/13/2020
Applied DNA Sciences, Inc.
Molecular
H
05/11/2020
1drop Inc.
Molecular
H
05/11/2020
Abbott Molecular Inc.
Molecular
H, M
05/08/2020
Quidel Corporation
Antigen
H, M, W
05/08/2020
Gnomegen LLC
Molecular
H
05/07/2020
Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics - Rutgers University
Molecular
H
05/07/2020
Zymo Research Corporation
Molecular
H
05/06/2020
OPTI Medical Systems, Inc.
Molecular
H
05/06/2020
Sherlock BioSciences, Inc.
Molecular
H
05/06/2020
BioMérieux SA
Molecular
H
05/05/2020
Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company)
Molecular
H
05/04/2020
EUROIMMUN US Inc.
Serology IgG
H
05/04/2020
Sansure BioTech Inc.
Molecular
H
05/02/2020
Roche Diagnostics
Serology Antibody
H, M
05/01/2020
Bio-Rad Laboratories, Inc.
Molecular
H
05/01/2020
BioFire Diagnostics, LLC
Molecular
H, M
04/30/2020
Wadsworth Center, New York State Department of Health
Serology Total Antibody
H
04/29/2020
LabGenomics Co., Ltd.
Molecular
H
04/29/2020
Rheonix, Inc.
Molecular
H
04/29/2020
Bio-Rad Laboratories
Serology Total Antibody
H
04/27/2020
Seasun Biomaterials
Molecular
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.
Molecular
H
04/22/2020
altona Diagnostics GmbH
Molecular
H
04/21/2020
Seegene, Inc.
Molecular
H
04/20/2020
Trax Management Services Inc.
Molecular
H
04/18/2020
OSANG Healthcare
Molecular
H
04/17/2020
Fosun Pharma USA Inc.
Molecular
H
04/16/2020
KorvaLabs Inc.
Molecular
H
04/16/2020
GenoSensor, LLC
Molecular
H
04/15/2020
Maccura Biotechnology (USA) LLC
Molecular
H
04/15/2020
Mount Sinai Laboratory
Serology IgG
H
04/14/2020
Chembio Diagnostic System, Inc.
Serology IgM and IgG
H, M
04/14/2020
Ortho Clinical Diagnostics, Inc.
Serology Total Antibody
H, M
04/10/2020
Atila BioSystems, Inc.
Molecular
H
04/08/2020
DiaCarta, Inc.
Molecular
H

04/08/2020
Becton, Dickinson & Company
Molecular
H, M

04/07/2020
InBios International, Inc.
Molecular
H

04/06/2020
Gnomegen LLC
Molecular
H

04/03/2020
Co-Diagnostics, Inc.
Molecular
H

04/03/2020
ScienCell Research Laboratories
Molecular
H

04/03/2020
Luminex Corporation
Molecular
H, M

04/02/2020
Becton, Dickinson & Company (BD)
Molecular
H, M

04/01/2020
Ipsum Diagnostics, LLC
Molecular
H

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

03/30/2020
QIAGEN GmbH
Molecular
H, M

03/30/2020
NeuMoDx Molecular, Inc.
Molecular
H, M

03/27/2020
Abbott Diagnostics Scarborough, Inc.
Molecular
H, M, W

03/27/2020
Luminex Molecular Diagnostics, Inc.
Molecular
H

03/26/2020
BGI Genomics Co. Ltd.
Molecular
H

03/25/2020
Avellino Lab USA, Inc.
Molecular
H

03/24/2020
PerkinElmer, Inc.
Molecular
H

03/23/2020
Mesa Biotech Inc.
Molecular
H, M, W

03/23/2020
BioFire Defense, LLC
Molecular
H, M

03/20/2020
Cepheid
Molecular
H, M, W

03/20/2020
Primerdesign Ltd.
Molecular
H

03/19/2020
GenMark Diagnostics, Inc.
Molecular
H, M

03/19/2020
DiaSorin Molecular LLC
Molecular
H, M

03/18/2020
Abbott Molecular
Molecular
H

03/17/2020
Quest Diagnostics Infectious Disease, Inc.
Molecular
H

03/17/2020
Quidel Corporation
Molecular
H

03/16/2020
Laboratory Corporation of America (LabCorp)
Molecular
H

03/16/2020
Hologic, Inc.
Molecular
H

03/13/2020
Thermo Fisher Scientific, Inc.
Molecular
H

03/12/2020
Roche Molecular Systems, Inc. (RMS)
Molecular
H, M

02/29/2020
Wadsworth Center, New York State Department of Public Health's (CDC)
Molecular
H

02/04/2020
Centers for Disease Control and Prevention's (CDC)
Molecular
H



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 (19):

  • Advanced Biological Laboratories (ABL) S.A. UltraGene Combo2Screen SARS-CoV-2 Assay
  • Alpha Pharma Service srl, IRIS SARS-CoV-2 IgG/IgM Rapid Test
  • 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
  • ChromaCode, Inc. HDPCR SARS-CoV-2 Assay
  • Co-Diagnostics, Inc. (FDA Authorized)
  • GeneOne Diagnostics Corporation COVID-19 Nucleic Acid Diagnostic Kit
  • Genomictree, Inc. AccuraDTect SARS-CoV-2-qPCR Kit
  • Hologic, Inc. Aptima SARS-CoV-2 Assay
  • LabGenomics, Co., Ltd. LabGun™ COVID-19 Assay Kit (FDA Authorized)
  • 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
  • Solgent Co. Ltd., COVID-19 DiaplexQ Diagnostic Kit
  • VelaDx ViroKey™ SARS-CoV-2 RT-PCR Test
  • YD Diagnostics Corp. MolecuTech Real-Time COVID-19

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 (17):

  • Arrayit Corporation
  • BioDiagnostic Labs LLC
  • Center for Cellular Therapy Medical University of South Carolina
  • DLS Research & Ventures
  • EDP Biotech Corporation
  • Emory Medical Laboratories
  • Enzo Clinical Labs
  • Genalyte, Inc
  • IGeneX Inc.
  • IMMYLabs
  • KSL Diagnostics
  • LabCorp Center for Esoteric Testing
  • OneBlood, 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 (191):

  • Abbexa Ltd abx294171 - COVID-19 IgG/IgM Rapid Test Kit
  • Abbott Laboratories SARS-CoV-2 IgG (for use on ARCHITECT) (FDA Authorized)
  • Access Bio, Inc. CareStart COVID-19 IgM/IgG
  • AccoBiotech SDN.BHD ACCO COVID-19 IgM/IgG Test
  • Alfa Scientific Designs, Inc. Instant-view plus COVID-19 IgG/IgM Antibody Test
  • Alfa Scientific Designs, Inc. Clarity COVID-19 IgG/IgM Antibody Test
  • Ameda Labordiagnostik GmbH AMP Rapid Test SARS-CoV-2 IgG/IgM
  • 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)
  • Assure Tech (Hangzhou) Co., Ltd.'s COVID-19 IgG/IgM Rapid Test Device
  • Atlas Link (Beijing)Technology Co., Ltd NovaTest: One Step COVID-19 IgG/IgM Rapid Test
  • Aurora Biomed Inc. COVID-19 IgG/IgM Rapid Test Cassette (Colloidal Gold)
  • Autobio Diagnostics' Anti-SARS-CoV-2 Rapid Test (FDA Authorized)
  • 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)
  • Beijing Beier Bioengineering Co., Ltd 2019-New Coronavirus IgG/IgM Rapid Test Cassette (WB/S/P)
  • Beijing Decombio Biotechnology Co., Ltd. Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette (Serum/Plasma/Whole blood)
  • 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
  • Beroni Group SARS-CoV-2 IgG/IgM Antibody Detection Kit
  • 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)
  • Biogate Laboratories Ltd COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)
  • Biohit Healthcare (Hefei) Co., Ltd. SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method)
  • Biolidics Limited 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold)
  • Biomerica, Inc. COVID-19 IgG/IgM Rapid Test
  • 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
  • BioSys Laboratories, Inc. BioSys Plus COVID-19 IgM/IgG Rapid Test
  • Boditech Med Inc AFIAS COVID-19 Ab Serological Tests
  • Boston Bio Lab Inc. Novel Corona Virus (COVID-19) IgM/IgG Rapid Test Device
  • Boston Biopharma Inc. BB Rapid-MT
  • BTNX, Inc. Rapid Response™ COVID-19 IgG/IgM Test Cassette
  • Calbiotech, Inc. ErbaLisa® COVID-19 IgG
  • Camtech Diagnostics Pte Ltd Camtech Covid-19 IgM/IgG 2C Rapid Test
  • Camtech Diagnostics Pte Ltd Camtech Covid-19 IgM/IgG 1C Rapid Test
  • Chembio Diagnostic Systems, Inc. DPP COVID-19 IgM/IgG System (FDA Authorized)
  • 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)
  • Diazyme Laboratories, Inc. Diazyme DZ-LITE SARS-CoV-2 IgG CLIA Kit
  • Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-Cov-2 IgM CLIA Kit
  • Diazyme Laboratories, Inc. Diazyme SARS-CoV-2 Antibody Rapid Test
  • 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. 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)
  • Fosun Pharma USA Inc. Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit
  • GenBody Inc. GenBody COVID-19 IgM/IgG
  • 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
  • Genobio Pharmaceutical Co., Ltd. COVID-19 IgM/IgG Lateral Flow Assay
  • Genrui Biotech Inc. Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold)
  • Getein Biotech Inc. One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold)
  • Goldsite Diagnostics Inc SARS-CoV-2 IgG/IgM Kit
  • Guangdong Hecin Scientific, Inc. SARS-CoV-2 IgM Antibody Rapid Test Kit
  • Guangzhou Decheng biotechnology DOCHEK™ SARS-CoV-2 Antibody Rapid Test Kit
  • Guangzhou Fenghua Bioengineering Co., Ltd. SARS-CoV-2 IgG/IgM Rapid Test
  • 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)
  • H-Guard (China) Co., Ltd. Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold)
  • 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
  • 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)
  • HUMASIS Co., Ltd. Humasis COVID-19 IgG/IgM Test
  • ICT international 2019-nCoV IgG/IgM Rapid Test Cassette
  • Innovation Biotech (Beijing) Co., Ltd. SARS-COV-2 IgM/IgG Antibody Rapid Test (Immunochromatographic Method)
  • 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 Dablood Pharmaceutical Co. Ltd. COVID-19 IgM/IgG Rapid 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. DualTec SARS-CoV-2(COVID-19) IgM/IgG Antibody Fast Detection 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)
  • Lepu Medical Technology (Beijing) Co., Ltd. Lepu SARS-CoV-2 Antibody Test (colloidal gold immunochromatography)
  • 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
  • Melbourne Biotech MB COVID-19 Antibody Detection Kit
  • 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 SYNTHGENE Medical Technology Co., Ltd. SYNTHGENE COVID-19 IgM/IgG Rapid Detection Kit (Colloidal Gold Method)
  • Nanjing Vazyme Medical Technology Co., LTD. 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based)
  • NanoEntek, Inc. FREND COVID-19 IgG/IgM Duo
  • NanoResearch, Inc. NanoMedicina™ SARS-COV-2 IgM/IgG Antibody Rapid Test
  • Nantong Diagnos Biotechnology Co., Ltd. (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold)
  • Nantong Egens Biotechnology Co., Ltd EGENS COVID-19 IgG/IgM Rapid Test Kit
  • Naturitious LLC Viralert COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT
  • NewScen Coast Bio-Pharmaceutical Co., Ltd. Covid-19 IgG/IgM Rapid Test
  • Nirmidas Biotech, Inc. COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit
  • Norman Biological Technology Co., Ltd Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold)
  • Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold)
  • One Milo, Inc. InstantRapid® SARS CoV-2 IgG IgM 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)
  • Pacific Connect Group LLC (US) SARS-CoV-2 IgG/IgM Rapid Test Kit
  • PCL Inc. COVID19 IgG/IgM Rapid Gold
  • PerGrande BioTech Development Co., Ltd. SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay)
  • Phamatech Inc. COVID19 IgG/IgM Rapid Test
  • Promedical Equipment Pty Ltd Promedical IgM/IgG Rapid Detection Kit
  • Prometheus Bio Inc. 2019-nCoV IgG/IgM Test (Whole blood/Serum/Plasma) Colloidal Gold
  • 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
  • RayBiotech, Inc. Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method)
  • RayBiotech, Inc. Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method)
  • 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)
  • Safecare Biotech (Hangzhou) Co., Ltd SAFECARE COVID-19 IgG/IgM Rapid Test Device
  • 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
  • SD Biosensor STANDARD Q COVID-19 IgM/IgG Duo
  • Sensing Self Pte. Ltd. COVID-19 Rapid IgM/IgG Combined Antibody Assay Pre-Screening Kit<.li>
  • 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
  • Shanghai Outdo Biotech Co., Ltd. Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) 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)
  • 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)
  • Sugentech, Inc. SGTi-flex COVID-19 IgM/IgG
  • Sure Bio-tech API Covid-Rapid IgM/IgG Antibody Test Kit
  • SUREDX V-CHEK™ SARS-CoV-2 Antibody Rapid Test Kit
  • Suzhou Kangheshun Medical Technology Co., Ltd SARS-CoV-2 IgG/IgM Rapid Test Cassette
  • 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 Beroni Biotechnology Co. Ltd SARS-CoV-2 IgG/IgM Antibody Detection Kit
  • 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
  • Universal Meditech Inc. DiagnosUS® SARS-CoV-2 Antibody (IgG/IgM) Test
  • VicTorch Meditek Inc. COVID-19 IgG/IgM Rapid test Cassette
  • Virotech Diagnostics GmbH Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit
  • Virotech Diagnostics GmbH Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit
  • Virotech Diagnostics GmbH Gold Standard Diagnostics SARS-CoV-2 IgA ELISG Test Kit
  • VivaChek Biotech (Hangzhou) Co., Ltd. VivaDiag COVID-19 IgM/IgG Rapid Test
  • Vivera Pharmaceuticals, Inc. Vivera Pharma COVID-19 Rapid Test
  • W.H.P.M. Inc., COVID-19 IgM/IgG Rapid Test
  • W.H.P.M. Inc., COVISURE™ COVID-19 IgM/IgG Rapid Test
  • Wuhan EasyDiagnosis Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody 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 Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold)
  • 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. ZEUS Rapid SARS-CoV-2 IgM/IgG 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 Encode Medical Engineering Co., Ltd Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device
  • Zhuhai Keyu Biological Engineering Co., Ltd. SARS-CoV-2 IgG/IgM Rapid Test Kit
  • Zhuhai Livzon Diagnostics, Inc. Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold)
  • Zybio Inc. SARS-CoV-2 IgM/IgG Antibody Assay Kit (Colloidal Gold Method)