COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Medical Devices Pipeline Assessment, 2020

COVID 19 EIA/ELISA are the most widely used assays having high sensitivity and specificity. They are used to detect the recombinant protein and peptide antigens in the samples. ELISA’s are specifically designed to screen large number of samples at a time. GlobalData's Medical Devices sector report, “COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Medical Devices Pipeline Assessment, 2020" provides comprehensive information about the COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

The COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) Pipeline Assessment report provides key information and data related to:

Extensive coverage of the COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) under development

Review details of major pipeline products which include product description, licensing and collaboration details and other developmental activities including pipeline territories, regulatory paths and estimated approval dates

Reviews of major players involved in the pipeline product development.

Provides key clinical trial data related to ongoing clinical trials such as trial phase, trial status, trial start and end dates, and, the number of trials of the major COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) pipeline products.

Review of Recent Developments in the segment / industry

The COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) Pipeline Assessment report enables you to:

Access significant competitor information, analysis, and insights to improve your R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand important and diverse types of Glaucoma Drainage Device sunder development

Formulate market-entry and market expansion strategies

Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline

The major companies covered in the “COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Medical Devices Pipeline Assessment, 2020” report:

1.

2. AgPlus Diagnostics LTD

3. AXO Science SAS

4. Beckman Coulter Inc

5. British Heart Foundation

6. China Medical Technologies Inc (Inactive)

7. Johns Hopkins University

8. Nanosphere Inc

9. Ortho-Clinical Diagnostics Inc

10. Roche Diagnostics International Ltd

11. SDIX LLC

12. Siemens Healthcare Diagnostics Inc

13. Siemens Healthineers AG

14. Singulex Inc

15. Soroka University Medical Center

16. Tosoh Bioscience Inc

17. University of Alberta

18. Upstream Medical Technologies Ltd

Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

The GlobalData Differentiation

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

The data and analysis within this report are driven by GlobalData Medical Intelligence Center (GDMIC) database. GDMIC gives you the key information required to drive sales, investment and deal-making activity in your business. It includes the following:

• 15,000+ data tables showing market size across more than 780 medical equipment segments and 39 countries, from 2015 and forecast to 2025

• 6,700+ industry-leading analysis reports covering sector reports, medipoint reports, country analysis, expert insights and industry analysis (devices and procedures) reports

• 64,000+ medical equipment company profiles

• 5,600+ company profiles of medical equipment manufacturers in China and India

• 2,200+ company profiles of medical equipment manufacturers in Japan

• 1,200+ companies’ revenue splits and market shares

• 1,600+ quarterly and annual medical equipment company financials

• 850+ medical equipment company SWOTs

• 28,000+ pipeline product profiles

• 56,400+ marketed product profiles

• 47,000+ clinical trials

• 41,500+ trial investigators

• 7,000+ reports on companies with products in development

• 44,000+ deals in the medical equipment industry

• 1,100+ surgical and diagnostic procedures by therapy area

• 50+ key healthcare indicators by country

• 431,000+ Themes Content Items

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For more information or to receive a free demonstration of the service, please visit:

https://medical.globaldata.com/home.aspx

Custom Requirements

Contact us to discuss the areas of your business where you need external input, and we will work with you to identify the strongest way forward to meet your needs.

Scope

Extensive coverage of the COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) under development

The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities

The report reviews the major players involved in the development of COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) and list all their pipeline projects

The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage

The report provides key clinical trial data of ongoing trials specific to pipeline products

Recent developments in the segment / industry

Reasons to buy

The report enables you to:

Formulate significant competitor information, analysis, and insights to improve R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand important and diverse types of COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) under development

Develop market-entry and market expansion strategies

Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline

In-depth analysis of the product’s current stage of development, territory and estimated launch date

Companies mentioned

20/20 GeneSystems Inc

Abbott Diagnostics

Abbott Laboratories

Absology Co Ltd

Abwiz Bio Inc

Achira Labs Pvt Ltd

ADiTx Therapeutics Inc

ADMA Biologics Inc

AegirBio AB

Aegis Sciences Corp

AESKU Diagnostics GmbH & Co KG

ALPCO Diagnostics

Anhui Deep Blue Medical Technology Co Ltd

Ansh Labs LLC

Arrayit Corporation

ARUP Laboratories

Avacta Group Plc

Axim Biotechnologies Inc

Axium BioResearch Inc

Babson Diagnostics Inc

Base10 Genetics Inc

Beckman Coulter Inc

Beijing Shengkun Kangru Medical Equipment Co Ltd

Ben-Gurion University of the Negev

Bio Techne Corp

Biohit Healthcare Ltd

BioIQ Inc

Biolinker Synthetic Biology Ltd

Biomerica Inc

Bloom Diagnostics AG

BreviTest Technologies LLC

Calviri Inc

CareHealth America Corp

Cellmid Ltd

Clinomics Inc

Core Technology Co Ltd

DiabetOmics Inc

DiaCarta Inc

Diagnostics Biochem Canada Inc

DIALAB GmbH

DiaSorin Inc

DLS Research and Ventures

DRG International Inc

EDP Biotech Corporation

Empower Clinics Inc

Enable Biosciences Inc

Enzo Biochem Inc

Epigentek Group Inc

Epitope Diagnostics, Inc.

Erba Mannheim

Eurofins Scientific SE

Euroimmun AG

Excelsior Bio-Systems Inc

Ezra AI Inc

Fujirebio Diagnostics Inc

Gauss Surgical Inc

General Biologicals Corp

Genspeed Biotech Gmbh

Hecin Scientific Inc

Icosagen AS

IDvet

Immunodiagnostics Ltd

ImmunoPrecise Antibodies Ltd

Indian Institute of Technology Guwahati

Interpace Biosciences Inc

Kantaro Biosciences LLC

Kephera Diagnostics LLC

KRISHGEN BioSystems

Lansion Biotechnology Co Ltd

Leadgene Biomedical Inc

Leinco Technologies Inc

Lumos Diagnostics Inc

Maxim Biomedical Inc

Module Innovations Pvt Ltd

Mologic Ltd

Monarch Global Health LLC

Monopar Therapeutics Inc

Nanjing Liming Bio-Products Co Ltd

Nirmidas Biotech Inc

Northwestern University

NovaTec Immundiagnostica GmbH

Novo Nordisk AS

OraSure Technologies Inc

Ortho-Clinical Diagnostics Inc

Oy Medix Biochemica Ab

Pepex Biomedical, Inc.

PerkinElmer Inc

Phadia AB

Pinnacle BioLabs

Prantae Solutions Pvt Ltd

Premier Medical Corporation

ProGnosis Biotech SA

Promega Corp

ProMIS Neurosciences Inc

Qiagen NV

Qlife Holding AB

Quanterix Corp

Roche Diagnostics International Ltd

Safetest Comercio de Diagnosticos Ltd

Sciteck Diagnostics Inc

Shenzhen Kingfocus Biomedical Engineering Co Ltd

Shenzhen Tisenc Medical Devices Co Ltd

Shijiazhuang Hipro Biotechnology Co Ltd

Siemens Healthcare Diagnostics Inc

Siemens Healthineers AG

SQI Diagnostics Inc

St Petersburg Research Institute of Vaccines and Sera

Stream Bio Ltd

Syngene

Sysmex Corp

Taizhou ZECEN Biotech Co Ltd

The Binding Site Inc

ThermoGenesis Holdings Inc

Trinity Biotech Plc

University of Melbourne

VidaCheck LLC

Vivera Pharmaceuticals Inc

Vyriad Inc

West Virginia University School of Medicine

Zalgen Labs LLC

Zandcell AB

ZEUS Scientific Inc

Table of Contents

1 Table of Contents 2

1.1 List of Tables 8

1.2 List of Figures 16

2 Introduction 17

2.1 COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) Overview 17

3 Products under Development 18

3.1 COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Pipeline Products by Stage of Development 18

3.2 COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Pipeline Products by Territory 19

3.3 COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Pipeline Products by Regulatory Path 20

3.4 COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Pipeline Products by Estimated Approval Date 21

3.5 COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Ongoing Clinical Trials 22

4 COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Pipeline Products under Development by Companies 23

4.1 COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) Companies – Pipeline Products by Stage of Development 23

4.2 COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Pipeline Products by Stage of Development 28

5 COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) Companies and Product Overview 33

5.1 20/20 GeneSystems Inc Company Overview 33

5.1.1 20/20 GeneSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 33

5.2 Abbott Diagnostics Company Overview 34

5.2.1 Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 34

5.3 Abbott Laboratories Company Overview 36

5.3.1 Abbott Laboratories Pipeline Products & Ongoing Clinical Trials Overview 36

5.4 Absology Co Ltd Company Overview 37

5.4.1 Absology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 37

5.5 Abwiz Bio Inc Company Overview 38

5.5.1 Abwiz Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 38

5.6 Achira Labs Pvt Ltd Company Overview 39

5.6.1 Achira Labs Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 39

5.7 ADiTx Therapeutics Inc Company Overview 40

5.7.1 ADiTx Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 40

5.8 ADMA Biologics Inc Company Overview 41

5.8.1 ADMA Biologics Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.9 AegirBio AB Company Overview 42

5.9.1 AegirBio AB Pipeline Products & Ongoing Clinical Trials Overview 42

5.10 Aegis Sciences Corp Company Overview 43

5.10.1 Aegis Sciences Corp Pipeline Products & Ongoing Clinical Trials Overview 43

5.11 AESKU Diagnostics GmbH & Co KG Company Overview 44

5.11.1 AESKU Diagnostics GmbH & Co KG Pipeline Products & Ongoing Clinical Trials Overview 44

5.12 ALPCO Diagnostics Company Overview 46

5.12.1 ALPCO Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 46

5.13 Anhui Deep Blue Medical Technology Co Ltd Company Overview 49

5.13.1 Anhui Deep Blue Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

5.14 Ansh Labs LLC Company Overview 52

5.14.1 Ansh Labs LLC Pipeline Products & Ongoing Clinical Trials Overview 52

5.15 Arrayit Corporation Company Overview 54

5.15.1 Arrayit Corporation Pipeline Products & Ongoing Clinical Trials Overview 54

5.16 ARUP Laboratories Company Overview 55

5.16.1 ARUP Laboratories Pipeline Products & Ongoing Clinical Trials Overview 55

5.17 Avacta Group Plc Company Overview 56

5.17.1 Avacta Group Plc Pipeline Products & Ongoing Clinical Trials Overview 56

5.18 Axim Biotechnologies Inc Company Overview 59

5.18.1 Axim Biotechnologies Inc Pipeline Products & Ongoing Clinical Trials Overview 59

5.19 Axium BioResearch Inc Company Overview 60

5.19.1 Axium BioResearch Inc Pipeline Products & Ongoing Clinical Trials Overview 60

5.20 Babson Diagnostics Inc Company Overview 61

5.20.1 Babson Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 61

5.21 Base10 Genetics Inc Company Overview 63

5.21.1 Base10 Genetics Inc Pipeline Products & Ongoing Clinical Trials Overview 63

5.22 Beckman Coulter Inc Company Overview 64

5.22.1 Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 64

5.23 Beijing Shengkun Kangru Medical Equipment Co Ltd Company Overview 66

5.23.1 Beijing Shengkun Kangru Medical Equipment Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 66

5.24 Ben-Gurion University of the Negev Company Overview 67

5.24.1 Ben-Gurion University of the Negev Pipeline Products & Ongoing Clinical Trials Overview 67

5.25 Bio Techne Corp Company Overview 68

5.25.1 Bio Techne Corp Pipeline Products & Ongoing Clinical Trials Overview 68

5.26 Biohit Healthcare Ltd Company Overview 69

5.26.1 Biohit Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 69

5.27 BioIQ Inc Company Overview 71

5.27.1 BioIQ Inc Pipeline Products & Ongoing Clinical Trials Overview 71

5.28 Biolinker Synthetic Biology Ltd Company Overview 72

5.28.1 Biolinker Synthetic Biology Ltd Pipeline Products & Ongoing Clinical Trials Overview 72

5.29 Biomerica Inc Company Overview 73

5.29.1 Biomerica Inc Pipeline Products & Ongoing Clinical Trials Overview 73

5.30 Bloom Diagnostics AG Company Overview 74

5.30.1 Bloom Diagnostics AG Pipeline Products & Ongoing Clinical Trials Overview 74

5.31 BreviTest Technologies LLC Company Overview 75

5.31.1 BreviTest Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 75

5.32 Calviri Inc Company Overview 76

5.32.1 Calviri Inc Pipeline Products & Ongoing Clinical Trials Overview 76

5.33 CareHealth America Corp Company Overview 77

5.33.1 CareHealth America Corp Pipeline Products & Ongoing Clinical Trials Overview 77

5.34 Cellmid Ltd Company Overview 78

5.34.1 Cellmid Ltd Pipeline Products & Ongoing Clinical Trials Overview 78

5.35 Clinomics Inc Company Overview 79

5.35.1 Clinomics Inc Pipeline Products & Ongoing Clinical Trials Overview 79

5.36 Core Technology Co Ltd Company Overview 80

5.36.1 Core Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 80

5.37 DiabetOmics Inc Company Overview 81

5.37.1 DiabetOmics Inc Pipeline Products & Ongoing Clinical Trials Overview 81

5.38 DiaCarta Inc Company Overview 82

5.38.1 DiaCarta Inc Pipeline Products & Ongoing Clinical Trials Overview 82

5.39 Diagnostics Biochem Canada Inc Company Overview 83

5.39.1 Diagnostics Biochem Canada Inc Pipeline Products & Ongoing Clinical Trials Overview 83

5.40 DIALAB GmbH Company Overview 86

5.40.1 DIALAB GmbH Pipeline Products & Ongoing Clinical Trials Overview 86

5.41 DiaSorin Inc Company Overview 87

5.41.1 DiaSorin Inc Pipeline Products & Ongoing Clinical Trials Overview 87

5.42 DLS Research and Ventures Company Overview 88

5.42.1 DLS Research and Ventures Pipeline Products & Ongoing Clinical Trials Overview 88

5.43 DRG International Inc Company Overview 89

5.43.1 DRG International Inc Pipeline Products & Ongoing Clinical Trials Overview 89

5.44 EDP Biotech Corporation Company Overview 91

5.44.1 EDP Biotech Corporation Pipeline Products & Ongoing Clinical Trials Overview 91

5.45 Empower Clinics Inc Company Overview 92

5.45.1 Empower Clinics Inc Pipeline Products & Ongoing Clinical Trials Overview 92

5.46 Enable Biosciences Inc Company Overview 93

5.46.1 Enable Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 93

5.47 Enzo Biochem Inc Company Overview 94

5.47.1 Enzo Biochem Inc Pipeline Products & Ongoing Clinical Trials Overview 94

5.48 Epigentek Group Inc Company Overview 95

5.48.1 Epigentek Group Inc Pipeline Products & Ongoing Clinical Trials Overview 95

5.49 Epitope Diagnostics, Inc. Company Overview 96

5.49.1 Epitope Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 96

5.50 Erba Mannheim Company Overview 98

5.50.1 Erba Mannheim Pipeline Products & Ongoing Clinical Trials Overview 98

5.51 Eurofins Scientific SE Company Overview 99

5.51.1 Eurofins Scientific SE Pipeline Products & Ongoing Clinical Trials Overview 99

5.52 Euroimmun AG Company Overview 100

5.52.1 Euroimmun AG Pipeline Products & Ongoing Clinical Trials Overview 100

5.53 Excelsior Bio-Systems Inc Company Overview 104

5.53.1 Excelsior Bio-Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 104

5.54 Ezra AI Inc Company Overview 105

5.54.1 Ezra AI Inc Pipeline Products & Ongoing Clinical Trials Overview 105

5.55 Fujirebio Diagnostics Inc Company Overview 106

5.55.1 Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 106

5.56 Gauss Surgical Inc Company Overview 107

5.56.1 Gauss Surgical Inc Pipeline Products & Ongoing Clinical Trials Overview 107

5.57 General Biologicals Corp Company Overview 108

5.57.1 General Biologicals Corp Pipeline Products & Ongoing Clinical Trials Overview 108

5.58 Genspeed Biotech Gmbh Company Overview 109

5.58.1 Genspeed Biotech Gmbh Pipeline Products & Ongoing Clinical Trials Overview 109

5.59 Hecin Scientific Inc Company Overview 110

5.59.1 Hecin Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 110

5.60 Icosagen AS Company Overview 111

5.60.1 Icosagen AS Pipeline Products & Ongoing Clinical Trials Overview 111

5.61 IDvet Company Overview 113

5.61.1 IDvet Pipeline Products & Ongoing Clinical Trials Overview 113

5.62 Immunodiagnostics Ltd Company Overview 114

5.62.1 Immunodiagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 114

5.63 ImmunoPrecise Antibodies Ltd Company Overview 116

5.63.1 ImmunoPrecise Antibodies Ltd Pipeline Products & Ongoing Clinical Trials Overview 116

5.64 Indian Institute of Technology Guwahati Company Overview 117

5.64.1 Indian Institute of Technology Guwahati Pipeline Products & Ongoing Clinical Trials Overview 117

5.65 Interpace Biosciences Inc Company Overview 118

5.65.1 Interpace Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 118

5.66 Kantaro Biosciences LLC Company Overview 119

5.66.1 Kantaro Biosciences LLC Pipeline Products & Ongoing Clinical Trials Overview 119

5.67 Kephera Diagnostics LLC Company Overview 120

5.67.1 Kephera Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 120

5.68 KRISHGEN BioSystems Company Overview 121

5.68.1 KRISHGEN BioSystems Pipeline Products & Ongoing Clinical Trials Overview 121

5.69 Lansion Biotechnology Co Ltd Company Overview 124

5.69.1 Lansion Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 124

5.70 Leadgene Biomedical Inc Company Overview 125

5.70.1 Leadgene Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 125

5.71 Leinco Technologies Inc Company Overview 126

5.71.1 Leinco Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 126

5.72 Lumos Diagnostics Inc Company Overview 127

5.72.1 Lumos Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 127

5.73 Maxim Biomedical Inc Company Overview 128

5.73.1 Maxim Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 128

5.74 Module Innovations Pvt Ltd Company Overview 131

5.74.1 Module Innovations Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 131

5.75 Mologic Ltd Company Overview 132

5.75.1 Mologic Ltd Pipeline Products & Ongoing Clinical Trials Overview 132

5.76 Monarch Global Health LLC Company Overview 135

5.76.1 Monarch Global Health LLC Pipeline Products & Ongoing Clinical Trials Overview 135

5.77 Monopar Therapeutics Inc Company Overview 136

5.77.1 Monopar Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 136

5.78 Nanjing Liming Bio-Products Co Ltd Company Overview 137

5.78.1 Nanjing Liming Bio-Products Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 137

5.79 Neurix SA Company Overview 138

5.79.1 Neurix SA Pipeline Products & Ongoing Clinical Trials Overview 138

5.80 Nirmidas Biotech Inc Company Overview 139

5.80.1 Nirmidas Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 139

5.81 Northwestern University Company Overview 141

5.81.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 141

5.82 NovaTec Immundiagnostica GmbH Company Overview 142

5.82.1 NovaTec Immundiagnostica GmbH Pipeline Products & Ongoing Clinical Trials Overview 142

5.83 Novo Nordisk AS Company Overview 145

5.83.1 Novo Nordisk AS Pipeline Products & Ongoing Clinical Trials Overview 145

5.84 OraSure Technologies Inc Company Overview 147

5.84.1 OraSure Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 147

5.85 Ortho-Clinical Diagnostics Inc Company Overview 148

5.85.1 Ortho-Clinical Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 148

5.86 Oy Medix Biochemica Ab Company Overview 153

5.86.1 Oy Medix Biochemica Ab Pipeline Products & Ongoing Clinical Trials Overview 153

5.87 Pepex Biomedical, Inc. Company Overview 154

5.87.1 Pepex Biomedical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 154

5.88 PerkinElmer Inc Company Overview 155

5.88.1 PerkinElmer Inc Pipeline Products & Ongoing Clinical Trials Overview 155

5.89 Phadia AB Company Overview 156

5.89.1 Phadia AB Pipeline Products & Ongoing Clinical Trials Overview 156

5.90 Pinnacle BioLabs Company Overview 157

5.90.1 Pinnacle BioLabs Pipeline Products & Ongoing Clinical Trials Overview 157

5.91 Prantae Solutions Pvt Ltd Company Overview 158

5.91.1 Prantae Solutions Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 158

5.92 Premier Medical Corporation Company Overview 159

5.92.1 Premier Medical Corporation Pipeline Products & Ongoing Clinical Trials Overview 159

5.93 ProGnosis Biotech SA Company Overview 160

5.93.1 ProGnosis Biotech SA Pipeline Products & Ongoing Clinical Trials Overview 160

5.94 Promega Corp Company Overview 162

5.94.1 Promega Corp Pipeline Products & Ongoing Clinical Trials Overview 162

5.95 ProMIS Neurosciences Inc Company Overview 163

5.95.1 ProMIS Neurosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 163

5.96 Qiagen NV Company Overview 164

5.96.1 Qiagen NV Pipeline Products & Ongoing Clinical Trials Overview 164

5.97 Qlife Holding AB Company Overview 167

5.97.1 Qlife Holding AB Pipeline Products & Ongoing Clinical Trials Overview 167

5.98 Quanterix Corp Company Overview 168

5.98.1 Quanterix Corp Pipeline Products & Ongoing Clinical Trials Overview 168

5.99 Roche Diagnostics International Ltd Company Overview 170

5.99.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 170

5.100 Safetest Comercio de Diagnosticos Ltd Company Overview 172

5.100.1 Safetest Comercio de Diagnosticos Ltd Pipeline Products & Ongoing Clinical Trials Overview 172

5.101 Sciteck Diagnostics Inc Company Overview 173

5.101.1 Sciteck Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 173

5.102 Shenzhen Kingfocus Biomedical Engineering Co Ltd Company Overview 174

5.102.1 Shenzhen Kingfocus Biomedical Engineering Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 174

5.103 Shenzhen Tisenc Medical Devices Co Ltd Company Overview 175

5.103.1 Shenzhen Tisenc Medical Devices Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 175

5.104 Shijiazhuang Hipro Biotechnology Co Ltd Company Overview 176

5.104.1 Shijiazhuang Hipro Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 176

5.105 Siemens Healthcare Diagnostics Inc Company Overview 177

5.105.1 Siemens Healthcare Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 177

5.106 Siemens Healthineers AG Company Overview 179

5.106.1 Siemens Healthineers AG Pipeline Products & Ongoing Clinical Trials Overview 179

5.107 SQI Diagnostics Inc Company Overview 181

5.107.1 SQI Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 181

5.108 St Petersburg Research Institute of Vaccines and Sera Company Overview 182

5.108.1 St Petersburg Research Institute of Vaccines and Sera Pipeline Products & Ongoing Clinical Trials Overview 182

5.109 Stream Bio Ltd Company Overview 183

5.109.1 Stream Bio Ltd Pipeline Products & Ongoing Clinical Trials Overview 183

5.110 Syngene Company Overview 184

5.110.1 Syngene Pipeline Products & Ongoing Clinical Trials Overview 184

5.111 Sysmex Corp Company Overview 185

5.111.1 Sysmex Corp Pipeline Products & Ongoing Clinical Trials Overview 185

5.112 Taizhou ZECEN Biotech Co Ltd Company Overview 186

5.112.1 Taizhou ZECEN Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 186

5.113 The Binding Site Inc Company Overview 189

5.113.1 The Binding Site Inc Pipeline Products & Ongoing Clinical Trials Overview 189

5.114 The Johns Hopkins Bloomberg School of Public Health Company Overview 190

5.114.1 The Johns Hopkins Bloomberg School of Public Health Pipeline Products & Ongoing Clinical Trials Overview 190

5.115 ThermoGenesis Holdings Inc Company Overview 191

5.115.1 ThermoGenesis Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 191

5.116 Trinity Biotech Plc Company Overview 192

5.116.1 Trinity Biotech Plc Pipeline Products & Ongoing Clinical Trials Overview 192

5.117 University of Melbourne Company Overview 193

5.117.1 University of Melbourne Pipeline Products & Ongoing Clinical Trials Overview 193

5.118 VidaCheck LLC Company Overview 194

5.118.1 VidaCheck LLC Pipeline Products & Ongoing Clinical Trials Overview 194

5.119 Vivera Pharmaceuticals Inc Company Overview 195

5.119.1 Vivera Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 195

5.120 Vyriad Inc Company Overview 196

5.120.1 Vyriad Inc Pipeline Products & Ongoing Clinical Trials Overview 196

5.121 West Virginia University School of Medicine Company Overview 197

5.121.1 West Virginia University School of Medicine Pipeline Products & Ongoing Clinical Trials Overview 197

5.122 Zalgen Labs LLC Company Overview 198

5.122.1 Zalgen Labs LLC Pipeline Products & Ongoing Clinical Trials Overview 198

5.123 Zandcell AB Company Overview 201

5.123.1 Zandcell AB Pipeline Products & Ongoing Clinical Trials Overview 201

5.124 ZEUS Scientific Inc Company Overview 202

5.124.1 ZEUS Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 202

6 COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA)- Recent Developments 203

6.1 Oct 07, 2020: For COVID-19 detection and epidemiology, xMAP technology offers unique advantages 203

6.2 May 28, 2020: GeneTex releases high-affinity recombinant monoclonal antibodies to accelerate SARS-CoV-2 research 204

6.3 Apr 15, 2020: Todos Medical achieves medical importer status with US FDA 205

6.4 Mar 24, 2020: Helping expand COVID-19 antibody testing capacity 205

7 Appendix 206

7.1 Methodology 206

7.2 About GlobalData 210

7.3 Contact Us 210

List of Tables

Table 1: COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Pipeline Products by Stage of Development 18

Table 2: COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Pipeline Products by Territory 19

Table 3: COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Pipeline Products by Regulatory Path 20

Table 4: COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Pipeline Products by Estimated Approval Date 21

Table 5: COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Ongoing Clinical Trials 22

Table 6: COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) Companies – Pipeline Products by Stage of Development 23

Table 7: COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Pipeline Products by Stage of Development 28

Table 8: 20/20 GeneSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 33

Table 9: Quantitative Antibody Test – COVID-19 – Product Status 33

Table 10: Quantitative Antibody Test – COVID-19 – Product Description 33

Table 11: Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 34

Table 12: Alinity i AdviseDx SARS-CoV-2 IgM Assay – Product Status 34

Table 13: Alinity i AdviseDx SARS-CoV-2 IgM Assay – Product Description 34

Table 14: Alinity i System – SARS-CoV-2 IgG Test – Product Status 35

Table 15: Alinity i System – SARS-CoV-2 IgG Test – Product Description 35

Table 16: Abbott Laboratories Pipeline Products & Ongoing Clinical Trials Overview 36

Table 17: Architect AdviseDx Sars-Cov-2 IgM Assay – Product Status 36

Table 18: Architect AdviseDx Sars-Cov-2 IgM Assay – Product Description 36

Table 19: Absology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 37

Table 20: INIST COVID-19 IgM/IgG Rapid Test – Product Status 37

Table 21: INIST COVID-19 IgM/IgG Rapid Test – Product Description 37

Table 22: Abwiz Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 38

Table 23: RabWiz Ultra Sensitive COIV-19 Viral Antigen Test Kit – Product Status 38

Table 24: RabWiz Ultra Sensitive COIV-19 Viral Antigen Test Kit – Product Description 38

Table 25: Achira Labs Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 39

Table 26: ELISA Diagnostic Kit – COVID-19 – Product Status 39

Table 27: ELISA Diagnostic Kit – COVID-19 – Product Description 39

Table 28: ADiTx Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 40

Table 29: AditxtScore – COVID-19 Assay – Product Status 40

Table 30: AditxtScore – COVID-19 Assay – Product Description 40

Table 31: ADMA Biologics Inc Pipeline Products & Ongoing Clinical Trials Overview 41

Table 32: ImmunoRank Neutralization MICRO-ELISA Assay – Product Status 41

Table 33: ImmunoRank Neutralization MICRO-ELISA Assay – Product Description 41

Table 34: AegirBio AB Pipeline Products & Ongoing Clinical Trials Overview 42

Table 35: COVID-19 Test – Product Status 42

Table 36: COVID-19 Test – Product Description 42

Table 37: Aegis Sciences Corp Pipeline Products & Ongoing Clinical Trials Overview 43

Table 38: IgM And IgG Antibody Test – COVID-19 – Product Status 43

Table 39: IgM And IgG Antibody Test – COVID-19 – Product Description 43

Table 40: AESKU Diagnostics GmbH & Co KG Pipeline Products & Ongoing Clinical Trials Overview 44

Table 41: AESKULISA SARS-CoV-2 NP IgG Antibody Test – Product Status 44

Table 42: AESKULISA SARS-CoV-2 NP IgG Antibody Test – Product Description 44

Table 43: AESKULISA SARS-CoV-2 NP IgM Antibody Test – Product Status 45

Table 44: AESKULISA SARS-CoV-2 NP IgM Antibody Test – Product Description 45

Table 45: ALPCO Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 46

Table 46: ALPCO SARS-CoV-2 IgG Chemiluminescence ELISA – Product Status 46

Table 47: ALPCO SARS-CoV-2 IgG Chemiluminescence ELISA – Product Description 46

Table 48: ALPCO SARS-CoV-2 IgG ELISA – Product Status 47

Table 49: ALPCO SARS-CoV-2 IgG ELISA – Product Description 47

Table 50: ALPCO SARS-CoV-2 IgM Chemiluminescence ELISA – Product Status 47

Table 51: ALPCO SARS-CoV-2 IgM Chemiluminescence ELISA – Product Description 48

Table 52: ALPCO SARS-CoV-2 IgM ELISA – Product Status 48

Table 53: ALPCO SARS-CoV-2 IgM ELISA – Product Description 48

Table 54: Anhui Deep Blue Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

Table 55: COVID- 19(SARS-CoV-2)IgG Antibody Test Kit – Product Status 49

Table 56: COVID- 19(SARS-CoV-2)IgG Antibody Test Kit – Product Description 49

Table 57: COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (Colloidal Gold) – Product Status 50

Table 58: COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (Colloidal Gold) – Product Description 50

Table 59: COVID-19(SARS-CoV-2) IgM Antibody Test Kit – Product Status 50

Table 60: COVID-19(SARS-CoV-2) IgM Antibody Test Kit – Product Description 51

Table 61: Ansh Labs LLC Pipeline Products & Ongoing Clinical Trials Overview 52

Table 62: SARS-CoV-2 IgG ELISA – Product Status 52

Table 63: SARS-CoV-2 IgG ELISA – Product Description 52

Table 64: SARS-CoV2 IgM ELISA – µ-Capture – Product Status 53

Table 65: SARS-CoV2 IgM ELISA – µ-Capture – Product Description 53

Table 66: Arrayit Corporation Pipeline Products & Ongoing Clinical Trials Overview 54

Table 67: Finger Stick Test – SARS-CoV-2 (COVID-19) Antibody – Product Status 54

Table 68: Finger Stick Test – SARS-CoV-2 (COVID-19) Antibody – Product Description 54

Table 69: ARUP Laboratories Pipeline Products & Ongoing Clinical Trials Overview 55

Table 70: COVID-19 Test – Product Status 55

Table 71: COVID-19 Test – Product Description 55

Table 72: Avacta Group Plc Pipeline Products & Ongoing Clinical Trials Overview 56

Table 73: Affimer-Based BAMS Coronavirus Antigen Test – Product Status 56

Table 74: Affimer-Based BAMS Coronavirus Antigen Test – Product Description 56

Table 75: Avacta Group Plc – Ongoing Clinical Trials Overview 57

Table 76: Affimer-Based BAMS Coronavirus Antigen Test – Study to Evaluate and Clinically Validate the High Throughput COVID-19 Bead-Assisted Mass Spectrometry 58

Table 77: Axim Biotechnologies Inc Pipeline Products & Ongoing Clinical Trials Overview 59

Table 78: NeuCovix-HT – Product Status 59

Table 79: NeuCovix-HT – Product Description 59

Table 80: Axium BioResearch Inc Pipeline Products & Ongoing Clinical Trials Overview 60

Table 81: COVID-19 IgG/IgM Antibody Test – Product Status 60

Table 82: COVID-19 IgG/IgM Antibody Test – Product Description 60

Table 83: Babson Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 61

Table 84: SARS-CoV-2 IgA Assay – Product Status 61

Table 85: SARS-CoV-2 IgA Assay – Product Description 61

Table 86: SARS-CoV-2 IgM Assay – Product Status 62

Table 87: SARS-CoV-2 IgM Assay – Product Description 62

Table 88: Base10 Genetics Inc Pipeline Products & Ongoing Clinical Trials Overview 63

Table 89: AccuFind COVID19 IgG Test – Product Status 63

Table 90: AccuFind COVID19 IgG Test – Product Description 63

Table 91: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 64

Table 92: Access SARS-CoV-2 IgG II Assay – Product Status 64

Table 93: Access SARS-CoV-2 IgG II Assay – Product Description 64

Table 94: Antigen Test – COVID-19 – Product Status 65

Table 95: Antigen Test – COVID-19 – Product Description 65

Table 96: SARS-CoV-2 Quantitative IgG Assay – Product Status 65

Table 97: SARS-CoV-2 Quantitative IgG Assay – Product Description 65

Table 98: Beijing Shengkun Kangru Medical Equipment Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 66

Table 99: 2019-nCoV Detection Kit – Product Status 66

Table 100: 2019-nCoV Detection Kit – Product Description 66

Table 101: Ben-Gurion University of the Negev Pipeline Products & Ongoing Clinical Trials Overview 67

Table 102: Immune Response Test – COVID-19 – Product Status 67

Table 103: Immune Response Test – COVID-19 – Product Description 67

Table 104: Bio Techne Corp Pipeline Products & Ongoing Clinical Trials Overview 68

Table 105: ELLA Cytokine Storm Panel – COVID-19 – Product Status 68

Table 106: ELLA Cytokine Storm Panel – COVID-19 – Product Description 68

Table 107: Biohit Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 69

Table 108: Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit – Product Status 69

Table 109: Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit – Product Description 69

Table 110: SARS-CoV-2 Antigen Assay Kit – Product Status 70

Table 111: SARS-CoV-2 Antigen Assay Kit – Product Description 70

Table 112: BioIQ Inc Pipeline Products & Ongoing Clinical Trials Overview 71

Table 113: IgG/IgM Antibody Detection Test – COVID-19 – Product Status 71

Table 114: IgG/IgM Antibody Detection Test – COVID-19 – Product Description 71

Table 115: Biolinker Synthetic Biology Ltd Pipeline Products & Ongoing Clinical Trials Overview 72

Table 116: Diagnostic Test – COVID-19 – Product Status 72

Table 117: Diagnostic Test – COVID-19 – Product Description 72

Table 118: Biomerica Inc Pipeline Products & Ongoing Clinical Trials Overview 73

Table 119: Serological ELISA Test – COVID-19 – Product Status 73

Table 120: Serological ELISA Test – COVID-19 – Product Description 73

Table 121: Bloom Diagnostics AG Pipeline Products & Ongoing Clinical Trials Overview 74

Table 122: Bloom COVID-19 Test – Product Status 74

Table 123: Bloom COVID-19 Test – Product Description 74

Table 124: BreviTest Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 75

Table 125: BreviTest SARS-CoV-2 IgG Test – Product Status 75

Table 126: BreviTest SARS-CoV-2 IgG Test – Product Description 75

Table 127: Calviri Inc Pipeline Products & Ongoing Clinical Trials Overview 76

Table 128: Immunosignaturing Test – SARS-CoV-2 – Product Status 76

Table 129: Immunosignaturing Test – SARS-CoV-2 – Product Description 76

Table 130: CareHealth America Corp Pipeline Products & Ongoing Clinical Trials Overview 77

Table 131: CoviCheck COVID-19 IgM/IgG Antibody Test – Product Status 77

Table 132: CoviCheck COVID-19 IgM/IgG Antibody Test – Product Description 77

Table 133: Cellmid Ltd Pipeline Products & Ongoing Clinical Trials Overview 78

Table 134: SARS-CoV-2 S1 IgG ELISA Kit – Product Status 78

Table 135: SARS-CoV-2 S1 IgG ELISA Kit – Product Description 78

Table 136: Clinomics Inc Pipeline Products & Ongoing Clinical Trials Overview 79

Table 137: TrioDx RT-PCR COVID-19 Test – Product Status 79

Table 138: TrioDx RT-PCR COVID-19 Test – Product Description 79

Table 139: Core Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 80

Table 140: CoreTest COVID-19 IgM/IgG Ab Test – Product Status 80

Table 141: CoreTest COVID-19 IgM/IgG Ab Test – Product Description 80

Table 142: DiabetOmics Inc Pipeline Products & Ongoing Clinical Trials Overview 81

Table 143: CovAbScreen SARS-CoV-2 Ab Test – Product Status 81

Table 144: CovAbScreen SARS-CoV-2 Ab Test – Product Description 81

Table 145: DiaCarta Inc Pipeline Products & Ongoing Clinical Trials Overview 82

Table 146: QuantiVirus Anti-SARS-CoV-2 IgG Test – Product Status 82

Table 147: QuantiVirus Anti-SARS-CoV-2 IgG Test – Product Description 82

Table 148: Diagnostics Biochem Canada Inc Pipeline Products & Ongoing Clinical Trials Overview 83

Table 149: Anti-SARS-CoV-2 IgA Elisa Kit – Product Status 83

Table 150: Anti-SARS-CoV-2 IgA Elisa Kit – Product Description 83

Table 151: Anti-SARS-Cov-2 IgM Elisa Kit – Product Status 84

Table 152: Anti-SARS-Cov-2 IgM Elisa Kit – Product Description 84

Table 153: Anti-SARS-CoV-2 Total Antibody (Ab) ELISA Kit – Product Status 84

Table 154: Anti-SARS-CoV-2 Total Antibody (Ab) ELISA Kit – Product Description 85

Table 155: DIALAB GmbH Pipeline Products & Ongoing Clinical Trials Overview 86

Table 156: SARS-CoV-2 IgG/IgM Antibody Test (Fluorescence Immunoassay) – Product Status 86

Table 157: SARS-CoV-2 IgG/IgM Antibody Test (Fluorescence Immunoassay) – Product Description 86

Table 158: DiaSorin Inc Pipeline Products & Ongoing Clinical Trials Overview 87

Table 159: LIAISON SARS-CoV-2 Ag – Product Status 87

Table 160: LIAISON SARS-CoV-2 Ag – Product Description 87

Table 161: DLS Research and Ventures Pipeline Products & Ongoing Clinical Trials Overview 88

Table 162: SCOV Immune Response Test – Product Status 88

Table 163: SCOV Immune Response Test – Product Description 88

Table 164: DRG International Inc Pipeline Products & Ongoing Clinical Trials Overview 89

Table 165: EIA-6146 SARS-CoV-2 IgG ELISA Kit – Product Status 89

Table 166: EIA-6146 SARS-CoV-2 IgG ELISA Kit – Product Description 89

Table 167: EIA-6147 SARS-CoV-2 IgM ELISA Kit – Product Status 90

Table 168: EIA-6147 SARS-CoV-2 IgM ELISA Kit – Product Description 90

Table 169: EDP Biotech Corporation Pipeline Products & Ongoing Clinical Trials Overview 91

Table 170: Antibody Test – COVID 19 – Product Status 91

Table 171: Antibody Test – COVID 19 – Product Description 91

Table 172: Empower Clinics Inc Pipeline Products & Ongoing Clinical Trials Overview 92

Table 173: Rapid COVID-19 Antibody Test Kits – Product Status 92

Table 174: Rapid COVID-19 Antibody Test Kits – Product Description 92

Table 175: Enable Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 93

Table 176: ADAP SARS-CoV-2 Total Antibody Assay – Product Status 93

Table 177: ADAP SARS-CoV-2 Total Antibody Assay – Product Description 93

Table 178: Enzo Biochem Inc Pipeline Products & Ongoing Clinical Trials Overview 94

Table 179: IgG/IgM Antibody Test – COVID-19 – Product Status 94

Table 180: IgG/IgM Antibody Test – COVID-19 – Product Description 94

Table 181: Epigentek Group Inc Pipeline Products & Ongoing Clinical Trials Overview 95

Table 182: SeroFlash SARS-CoV-2 IgG/IgM Antibody Detection Kit – Product Status 95

Table 183: SeroFlash SARS-CoV-2 IgG/IgM Antibody Detection Kit – Product Description 95

Table 184: Epitope Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 96

Table 185: EDI Novel Coronavirus COVID-19 IgG ELISA Kit – Product Status 96

Table 186: EDI Novel Coronavirus COVID-19 IgG ELISA Kit – Product Description 96

Table 187: EDI Novel Coronavirus COVID-19 IgM ELISA Kit – Product Status 97

Table 188: EDI Novel Coronavirus COVID-19 IgM ELISA Kit – Product Description 97

Table 189: Erba Mannheim Pipeline Products & Ongoing Clinical Trials Overview 98

Table 190: ErbaLisa COVID-19 IgG ELISA Kit – Product Status 98

Table 191: ErbaLisa COVID-19 IgG ELISA Kit – Product Description 98

Table 192: Eurofins Scientific SE Pipeline Products & Ongoing Clinical Trials Overview 99

Table 193: Pooled PCR Test – Product Status 99

Table 194: Pooled PCR Test – Product Description 99

Table 195: Euroimmun AG Pipeline Products & Ongoing Clinical Trials Overview 100

Table 196: Anti-SARS-CoV-2 Elisa (IgA) – Product Status 100

Table 197: Anti-SARS-CoV-2 Elisa (IgA) – Product Description 100

Table 198: Anti-SARS-CoV-2 QuantiVac ELISA (IgG) Assay – Product Status 101

Table 199: Anti-SARS-CoV-2 QuantiVac ELISA (IgG) Assay – Product Description 101

Table 200: Euroimmun AG – Ongoing Clinical Trials Overview 102

Table 201: Anti-SARS-CoV-2 Elisa (IgA) – Evaluation of the Immune Response in Symptomatic and Asymptomatic Patients Diagnosed with COVID-19 103

Table 202: Excelsior Bio-Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 104

Table 203: EBSALERT SARS-CoV-2 Antibody Rapid Test – Product Status 104

Table 204: EBSALERT SARS-CoV-2 Antibody Rapid Test – Product Description 104

Table 205: Ezra AI Inc Pipeline Products & Ongoing Clinical Trials Overview 105

Table 206: Antibody Testing Kit – COVID-19 – Product Status 105

Table 207: Antibody Testing Kit – COVID-19 – Product Description 105

Table 208: Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 106

Table 209: Lumipulse SARS CoV-2 Antigen Assay – Product Status 106

Table 210: Lumipulse SARS CoV-2 Antigen Assay – Product Description 106

Table 211: Gauss Surgical Inc Pipeline Products & Ongoing Clinical Trials Overview 107

Table 212: AI-enabled COVID-19 Rapid Antigen Test – Product Status 107

Table 213: AI-enabled COVID-19 Rapid Antigen Test – Product Description 107

Table 214: General Biologicals Corp Pipeline Products & Ongoing Clinical Trials Overview 108

Table 215: Total Antibody ELISA Test – Product Status 108

Table 216: Total Antibody ELISA Test – Product Description 108

Table 217: Genspeed Biotech Gmbh Pipeline Products & Ongoing Clinical Trials Overview 109

Table 218: Combined COVID19 IgG/Ag Test – Product Status 109

Table 219: Combined COVID19 IgG/Ag Test – Product Description 109

Table 220: Hecin Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 110

Table 221: COVID-19 IgM Antibody Test Kit – Product Status 110

Table 222: COVID-19 IgM Antibody Test Kit – Product Description 110

Table 223: Icosagen AS Pipeline Products & Ongoing Clinical Trials Overview 111

Table 224: COVID-19 Neutralising Antibody ELISA Test – Product Status 111

Table 225: COVID-19 Neutralising Antibody ELISA Test – Product Description 111

Table 226: SARS-CoV-2 Antigen Test – Product Status 112

Table 227: SARS-CoV-2 Antigen Test – Product Description 112

Table 228: IDvet Pipeline Products & Ongoing Clinical Trials Overview 113

Table 229: ID Screen SARS-CoV-2-N IgG Indirect – Product Status 113

Table 230: ID Screen SARS-CoV-2-N IgG Indirect – Product Description 113

Table 231: Immunodiagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 114

Table 232: Colloidal Gold-Based SARS-CoV-2 IgG/IgM Detection Kit – Product Status 114

Table 233: Colloidal Gold-Based SARS-CoV-2 IgG/IgM Detection Kit – Product Description 114

Table 234: SARS-CoV-2 NP IgG ELISA Kit – Product Status 115

Table 235: SARS-CoV-2 NP IgG ELISA Kit – Product Description 115

Table 236: ImmunoPrecise Antibodies Ltd Pipeline Products & Ongoing Clinical Trials Overview 116

Table 237: Real-Time Cell-Phone Based COVID-19 Antibody Diagnostic Test – Product Status 116

Table 238: Real-Time Cell-Phone Based COVID-19 Antibody Diagnostic Test – Product Description 116

Table 239: Indian Institute of Technology Guwahati Pipeline Products & Ongoing Clinical Trials Overview 117

Table 240: ELISA Test – COVID-19 – Product Status 117

Table 241: ELISA Test – COVID-19 – Product Description 117

Table 242: Interpace Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 118

Table 243: Serology Test – COVID-19 – Product Status 118

Table 244: Serology Test – COVID-19 – Product Description 118

Table 245: Kantaro Biosciences LLC Pipeline Products & Ongoing Clinical Trials Overview 119

Table 246: Serology Test Kit – COVID-19 – Product Status 119

Table 247: Serology Test Kit – COVID-19 – Product Description 119

Table 248: Kephera Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 120

Table 249: KDx COVID-19 IgG and IgM ELISA Test – Product Status 120

Table 250: KDx COVID-19 IgG and IgM ELISA Test – Product Description 120

Table 251: KRISHGEN BioSystems Pipeline Products & Ongoing Clinical Trials Overview 121

Table 252: GENLISA Human Anti-SARS-CoV-2 (COVID-19) Nucleocapsid Protein IgG ELISA – Product Status 121

Table 253: GENLISA Human Anti-SARS-CoV-2 (COVID-19) Nucleocapsid Protein IgG ELISA – Product Description 121

Table 254: GENLISA Human Anti-SARS-CoV-2 (COVID-19) Spike Protein IgG ELISA – Product Status 122

Table 255: GENLISA Human Anti-SARS-CoV-2 (COVID-19) Spike Protein IgG ELISA – Product Description 122

Table 256: GENLISA Human SARS-CoV Antigen ELISA – Product Status 122

Table 257: GENLISA Human SARS-CoV Antigen ELISA – Product Description 123

Table 258: GENLISA Human SARS-CoV-2 (COVID-19) ELISA – Product Status 123

Table 259: GENLISA Human SARS-CoV-2 (COVID-19) ELISA – Product Description 123

Table 260: Lansion Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 124

Table 261: (COVID-19) IgM/IgG Antibody Test Kit – Product Status 124

Table 262: (COVID-19) IgM/IgG Antibody Test Kit – Product Description 124

Table 263: Leadgene Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 125

Table 264: LEADGENE COVID-19 IgG/IgM Antibody ELISA Kit – Product Status 125

Table 265: LEADGENE COVID-19 IgG/IgM Antibody ELISA Kit – Product Description 125

Table 266: Leinco Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 126

Table 267: COVID-19 Trace IgG MICRO-ELISA – Product Status 126

Table 268: COVID-19 Trace IgG MICRO-ELISA – Product Description 126

Table 269: Lumos Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 127

Table 270: COV-ID – Product Status 127

Table 271: COV-ID – Product Description 127

Table 272: Maxim Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 128

Table 273: Antibody EIA Kit – Product Status 128

Table 274: Antibody EIA Kit – Product Description 128

Table 275: Antibody IgM/IgG Rapid Test Kit – Product Status 129

Table 276: Antibody IgM/IgG Rapid Test Kit – Product Description 129

Table 277: Combo Ag/Ab Rapid Test Kit – Product Status 129

Table 278: Combo Ag/Ab Rapid Test Kit – Product Description 130

Table 279: Maxim SARS-CoV-2 Rapid Antigen Diagnostic Test – Product Status 130

Table 280: Maxim SARS-CoV-2 Rapid Antigen Diagnostic Test – Product Description 130

Table 281: Module Innovations Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 131

Table 282: nCoVSENSe – Product Status 131

Table 283: nCoVSENSe – Product Description 131

Table 284: Mologic Ltd Pipeline Products & Ongoing Clinical Trials Overview 132

Table 285: Diagnostic ELISA Test – COVID-19 – Product Status 132

Table 286: Diagnostic ELISA Test – COVID-19 – Product Description 132

Table 287: Mologic Ltd – Ongoing Clinical Trials Overview 133

Table 288: Diagnostic ELISA Test – COVID-19 – Development and Assessment of Rapid Testing for SARS-CoV-2 Outbreak (DARTS) 134

Table 289: Monarch Global Health LLC Pipeline Products & Ongoing Clinical Trials Overview 135

Table 290: Magellan IgM and IgG Antibody Test Kit – Product Status 135

Table 291: Magellan IgM and IgG Antibody Test Kit – Product Description 135

Table 292: Monopar Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 136

Table 293: suPAR-based COVID-19 Test – Product Status 136

Table 294: suPAR-based COVID-19 Test – Product Description 136

Table 295: Nanjing Liming Bio-Products Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 137

Table 296: StrongStep SARS-CoV-2 lgM/IgG Antibody Rapid Test – Product Status 137

Table 297: StrongStep SARS-CoV-2 lgM/IgG Antibody Rapid Test – Product Description 137

Table 298: Neurix SA Pipeline Products & Ongoing Clinical Trials Overview 138

Table 299: Spike Neutralization Assay – Product Status 138

Table 300: Spike Neutralization Assay – Product Description 138

Table 301: Nirmidas Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 139

Table 302: MidaSpot COVID-19 Antibody Combo Detection Kit – Product Status 139

Table 303: MidaSpot COVID-19 Antibody Combo Detection Kit – Product Description 139

Table 304: pGOLD COVID-19 High Accuracy IgG/IgM Antibody Assay – Product Status 140

Table 305: pGOLD COVID-19 High Accuracy IgG/IgM Antibody Assay – Product Description 140

Table 306: Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 141

Table 307: Antibody Test – SARS-CoV-2 – Product Status 141

Table 308: Antibody Test – SARS-CoV-2 – Product Description 141

Table 309: NovaTec Immundiagnostica GmbH Pipeline Products & Ongoing Clinical Trials Overview 142

Table 310: NovaLisa COVID-19 (SARS-CoV-2) IgA – Product Status 142

Table 311: NovaLisa COVID-19 (SARS-CoV-2) IgA – Product Description 142

Table 312: NovaLisa COVID-19 (SARS-CoV-2) IgG – Product Status 143

Table 313: NovaLisa COVID-19 (SARS-CoV-2) IgG – Product Description 143

Table 314: NovaLisa COVID-19 (SARS-CoV-2) IgM – Product Status 143

Table 315: NovaLisa COVID-19 (SARS-CoV-2) IgM – Product Description 144

Table 316: Novo Nordisk AS Pipeline Products & Ongoing Clinical Trials Overview 145

Table 317: Direct ELISA Test – SARS-CoV-2 – Product Status 145

Table 318: Direct ELISA Test – SARS-CoV-2 – Product Description 145

Table 319: Sandwich ELISA Test – SARS-CoV-2 – Product Status 146

Table 320: Sandwich ELISA Test – SARS-CoV-2 – Product Description 146

Table 321: OraSure Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 147

Table 322: Oral Fluid ELISA Test – COVID-19 – Product Status 147

Table 323: Oral Fluid ELISA Test – COVID-19 – Product Description 147

Table 324: Ortho-Clinical Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 148

Table 325: VITROS Anti-SARS-CoV-2 IgG Test – Product Status 148

Table 326: VITROS Anti-SARS-CoV-2 IgG Test – Product Description 148

Table 327: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack – Product Status 149

Table 328: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack – Product Description 149

Table 329: VITROS SARS-CoV-2 Antigen Test – Product Status 149

Table 330: VITROS SARS-CoV-2 Antigen Test – Product Description 150

Table 331: Ortho-Clinical Diagnostics Inc – Ongoing Clinical Trials Overview 151

Table 332: VITROS Anti-SARS-CoV-2 IgG Test – Seroprevalence of SARS CoV2 Antibodies among Adults in Kingman AZ 152

Table 333: Oy Medix Biochemica Ab Pipeline Products & Ongoing Clinical Trials Overview 153

Table 334: Actim ELISA SARS CoV-2 IgG/IgM – Product Status 153

Table 335: Actim ELISA SARS CoV-2 IgG/IgM – Product Description 153

Table 336: Pepex Biomedical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 154

Table 337: COVID-19 Antibody Detection Test – Product Status 154

Table 338: COVID-19 Antibody Detection Test – Product Description 154

Table 339: PerkinElmer Inc Pipeline Products & Ongoing Clinical Trials Overview 155

Table 340: Dry Blood Spot Test – COVID 19 – Product Status 155

Table 341: Dry Blood Spot Test – COVID 19 – Product Description 155

Table 342: Phadia AB Pipeline Products & Ongoing Clinical Trials Overview 156

Table 343: Confirmed ELiA SARS-CoV-2-Sp1 IgG Test – Product Status 156

Table 344: Confirmed ELiA SARS-CoV-2-Sp1 IgG Test – Product Description 156

Table 345: Pinnacle BioLabs Pipeline Products & Ongoing Clinical Trials Overview 157

Table 346: CovID Rapid Antigen Detection Test – Product Status 157

Table 347: CovID Rapid Antigen Detection Test – Product Description 157

Table 348: Prantae Solutions Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 158

Table 349: EyeRa COVID 19 – Product Status 158

Table 350: EyeRa COVID 19 – Product Description 158

Table 351: Premier Medical Corporation Pipeline Products & Ongoing Clinical Trials Overview 159

Table 352: SureStatus COVID-19 (SARS-CoV-2) EIA Test – Product Status 159

Table 353: SureStatus COVID-19 (SARS-CoV-2) EIA Test – Product Description 159

Table 354: ProGnosis Biotech SA Pipeline Products & Ongoing Clinical Trials Overview 160

Table 355: Bio-Shield 2019-nCoV Total Ig ELISA – Product Status 160

Table 356: Bio-Shield 2019-nCoV Total Ig ELISA – Product Description 160

Table 357: Rapid Test 2019-nCoV Total Ig S – Product Status 161

Table 358: Rapid Test 2019-nCoV Total Ig S – Product Description 161

Table 359: Promega Corp Pipeline Products & Ongoing Clinical Trials Overview 162

Table 360: Lumit Dx SARS-CoV-2 Immunoassay – Product Status 162

Table 361: Lumit Dx SARS-CoV-2 Immunoassay – Product Description 162

Table 362: ProMIS Neurosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 163

Table 363: Antibody Test – COVID-19 – Product Status 163

Table 364: Antibody Test – COVID-19 – Product Description 163

Table 365: Qiagen NV Pipeline Products & Ongoing Clinical Trials Overview 164

Table 366: Access Anti-SARS-CoV-2 Antigen Test – Lab Use – Product Status 164

Table 367: Access Anti-SARS-CoV-2 Antigen Test – Lab Use – Product Description 165

Table 368: Access Anti-SARS-CoV-2 Total Serology Test – Product Status 165

Table 369: Access Anti-SARS-CoV-2 Total Serology Test – Product Description 165

Table 370: QIAreach SARS-CoV-2 Antigen Test – Lab Use – Product Status 166

Table 371: QIAreach SARS-CoV-2 Antigen Test – Lab Use – Product Description 166

Table 372: Qlife Holding AB Pipeline Products & Ongoing Clinical Trials Overview 167

Table 373: Egoo IgM/IgG Test – Product Status 167

Table 374: Egoo IgM/IgG Test – Product Description 167

Table 375: Quanterix Corp Pipeline Products & Ongoing Clinical Trials Overview 168

Table 376: Simoa Antibody Test – COVID-19 – Product Status 168

Table 377: Simoa Antibody Test – COVID-19 – Product Description 169

Table 378: Simoa SARS-Cov-2 Antigen Test – Product Status 169

Table 379: Simoa SARS-Cov-2 Antigen Test – Product Description 169

Table 380: Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 170

Table 381: Elecsys Anti-SARS-CoV-2 S Antibody Test – Product Status 170

Table 382: Elecsys Anti-SARS-CoV-2 S Antibody Test – Product Description 170

Table 383: Elecsys Anti-SARS-CoV-2 Test – Product Status 171

Table 384: Elecsys Anti-SARS-CoV-2 Test – Product Description 171

Table 385: Safetest Comercio de Diagnosticos Ltd Pipeline Products & Ongoing Clinical Trials Overview 172

Table 386: Safetest Covid-19 IgM/IgG ELISA Test Kit – Product Status 172

Table 387: Safetest Covid-19 IgM/IgG ELISA Test Kit – Product Description 172

Table 388: Sciteck Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 173

Table 389: COVID19 Automated Antibody Assay – Product Status 173

Table 390: COVID19 Automated Antibody Assay – Product Description 173

Table 391: Shenzhen Kingfocus Biomedical Engineering Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 174

Table 392: True-Dot Novel Coronavirus IgM/IgG Rapid Antibody Detection Kit – Product Status 174

Table 393: True-Dot Novel Coronavirus IgM/IgG Rapid Antibody Detection Kit – Product Description 174

Table 394: Shenzhen Tisenc Medical Devices Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 175

Table 395: Antibody Test Kit – COVID-19 – Product Status 175

Table 396: Antibody Test Kit – COVID-19 – Product Description 175

Table 397: Shijiazhuang Hipro Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 176

Table 398: 2019-nCoV IgM/IgG Antibody Test Kit – Product Status 176

Table 399: 2019-nCoV IgM/IgG Antibody Test Kit – Product Description 176

Table 400: Siemens Healthcare Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 177

Table 401: Atellica IM SARS-CoV-2 IgG (COV2G) – Product Status 177

Table 402: Atellica IM SARS-CoV-2 IgG (COV2G) – Product Description 177

Table 403: Dimension Exl SARS-CoV-2 IgG (Cv2g) – Product Status 178

Table 404: Dimension Exl SARS-CoV-2 IgG (Cv2g) – Product Description 178

Table 405: Siemens Healthineers AG Pipeline Products & Ongoing Clinical Trials Overview 179

Table 406: ADVIA Centaur SARS-CoV-2 IgG (COV2G) Assay – Product Status 179

Table 407: ADVIA Centaur SARS-CoV-2 IgG (COV2G) Assay – Product Description 180

Table 408: SARS-CoV-2 IgG Antibody Test (sCOVG) – Product Status 180

Table 409: SARS-CoV-2 IgG Antibody Test (sCOVG) – Product Description 180

Table 410: SQI Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 181

Table 411: COVID-19 HOME Antibody Test – Product Status 181

Table 412: COVID-19 HOME Antibody Test – Product Description 181

Table 413: St Petersburg Research Institute of Vaccines and Sera Pipeline Products & Ongoing Clinical Trials Overview 182

Table 414: SARS-CoV-2 Tru-EIA – Product Status 182

Table 415: SARS-CoV-2 Tru-EIA – Product Description 182

Table 416: Stream Bio Ltd Pipeline Products & Ongoing Clinical Trials Overview 183

Table 417: ELISA Assay – SARS-Cov-2 – Product Status 183

Table 418: ELISA Assay – SARS-Cov-2 – Product Description 183

Contd…

List of Figures

Figure 1: COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Pipeline Products by Stage of Development 18

Figure 2: COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Pipeline Products by Territory 19

Figure 3: COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Pipeline Products by Regulatory Path 20

Figure 4: COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Pipeline Products by Estimated Approval Date 21

Figure 5: COVID 19 Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) – Ongoing Clinical Trials 22

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