Retrovirus Rapid Tests & Point of Care (POC) – Medical Devices Pipeline Assessment, 2019

Retrovirus Rapid Tests & Point of Care (POC) are the rapid diagnostic tests used to detect the HIV 1 and HIV 2 (human immunodeficiency virus) viruses and generate results immediately in a limited resource setting. GlobalData's Medical Devices sector report, “Retrovirus Rapid Tests & Point of Care (POC) – Medical Devices Pipeline Assessment, 2019" provides comprehensive information about the Retrovirus Rapid Tests & Point of Care (POC) pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

The Retrovirus Rapid Tests & Point of Care (POC) Pipeline Assessment report provides key information and data related to:

Extensive coverage of the Retrovirus Rapid Tests & Point of Care (POC) 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 Retrovirus Rapid Tests & Point of Care (POC) pipeline products.

Review of Recent Developments in the segment / industry

The Retrovirus Rapid Tests & Point of Care (POC) 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 Retrovirus Rapid Tests & Point of Care (POC) under development

Formulate market-entry and market expansion strategies

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

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 2009 and forecast to 2023

• 4,500+ industry-leading analysis and procedure reports covering growing sectors, market trends, investment opportunities and competitive landscape

• 56,000+ medical equipment company profiles

• 4,300+ company profiles of medical equipment manufacturers in China and India

• 2,000+ company profiles of medical equipment manufacturers in Japan

• 825+ companies’ revenue splits and market shares

• 1,900+ quarterly and annual medical equipment company financials

• 940+ medical equipment company SWOTs

• 21,500+ pipeline product profiles

• 34,500+ marketed product profiles

• 36,000+ clinical trials

• 36,500+ trial investigators

• 5,400+ reports on companies with products in development

• 33,000+ deals in the medical equipment industry

• 1,300+ surgical and diagnostic procedures by therapy area

• 50+ key healthcare indicators by country

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

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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 Retrovirus Rapid Tests & Point of Care (POC) 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 Retrovirus Rapid Tests & Point of Care (POC) 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 Retrovirus Rapid Tests & Point of Care (POC) 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

Access Bio Inc

Akers Biosciences Inc

Aldatu Biosciences Inc

Alere Inc

Altratech Ltd

BBB Technologies Inc

Beijing Wantai Biological Pharmacy Enterprise Co Ltd

Binx Health Inc

Bio-AMD Inc

Biocartis Group NV

BioHelix Corp

Calypte Biomedical Corporation

Centre International de Reference Chantal Biya

Cepheid

Chembio Diagnostic Systems Inc

CrossLife Technologies Inc

Daktari Diagnostics, Inc.

Diagnostics For All Inc

Diagnostics for the Real World (Europe) Ltd

Endeavor Sciences Inc

Epinex Diagnostics Inc

ERBA Molecular Ltd

GAIA Medical Institute LLC

genedrive plc

Group K Diagnostics

HeatFlow Technologies Inc

Imperial College London

Jinvator Bio Med GmbH

Johns Hopkins University

Labsystems Diagnostics Oy

Micronics Inc

Molbio Diagnostics Pvt Ltd

Nanobiosym Inc

NeuMoDx Molecular Inc

Newmark Diagnostics LLC

Northwestern University

Orangelife

Osel Inc

QuantuMDx Group Ltd

Quidel Corp

Radisens Diagnostics Ltd

Rheonix Inc

Roche Diagnostics International Ltd

Sedia Biosciences Corp

TheoremDx Inc

Trinity Biotech Plc

University of Washington

UrSure Inc

Wave 80 Biosciences Inc

Yaathum Biotech Pvt Ltd

Table of Contents

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 8

2 Introduction 9

2.1 Retrovirus Rapid Tests & Point of Care (POC) Overview 9

Retrovirus Rapid Tests & Point of Care are the rapid diagnostic tests used to detect the HIV 1 and HIV 2 (human immunodeficiency virus) viruses and generate results immediately in a limited resource setting. 9

3 Products under Development 10

3.1 Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Stage of Development 10

3.2 Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Territory 11

3.3 Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Regulatory Path 12

3.4 Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Estimated Approval Date 13

4 Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products under Development by Companies 14

4.1 Retrovirus Rapid Tests & Point of Care (POC) Companies – Pipeline Products by Stage of Development 14

4.2 Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Stage of Development 16

5 Retrovirus Rapid Tests & Point of Care (POC) Companies and Product Overview 18

5.1 Access Bio Inc Company Overview 18

5.1.1 Access Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 18

5.2 Akers Biosciences Inc Company Overview 19

5.2.1 Akers Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 19

5.3 Aldatu Biosciences Inc Company Overview 20

5.3.1 Aldatu Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 20

5.4 Alere Inc Company Overview 21

5.4.1 Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 21

5.5 Altratech Ltd Company Overview 22

5.5.1 Altratech Ltd Pipeline Products & Ongoing Clinical Trials Overview 22

5.6 BBB Technologies Inc Company Overview 23

5.6.1 BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 23

5.7 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Company Overview 24

5.7.1 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 24

5.8 Binx Health Inc Company Overview 25

5.8.1 Binx Health Inc Pipeline Products & Ongoing Clinical Trials Overview 25

5.9 Bio-AMD Inc Company Overview 26

5.9.1 Bio-AMD Inc Pipeline Products & Ongoing Clinical Trials Overview 26

5.10 Biocartis Group NV Company Overview 27

5.10.1 Biocartis Group NV Pipeline Products & Ongoing Clinical Trials Overview 27

5.11 BioHelix Corp Company Overview 28

5.11.1 BioHelix Corp Pipeline Products & Ongoing Clinical Trials Overview 28

5.12 Calypte Biomedical Corporation Company Overview 30

5.12.1 Calypte Biomedical Corporation Pipeline Products & Ongoing Clinical Trials Overview 30

5.13 Centre International de Reference Chantal Biya Company Overview 32

5.13.1 Centre International de Reference Chantal Biya Pipeline Products & Ongoing Clinical Trials Overview 32

5.14 Cepheid Company Overview 33

5.14.1 Cepheid Pipeline Products & Ongoing Clinical Trials Overview 33

5.15 Chembio Diagnostic Systems Inc Company Overview 35

5.15.1 Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 35

5.16 CrossLife Technologies Inc Company Overview 38

5.16.1 CrossLife Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 38

5.17 Daktari Diagnostics, Inc. Company Overview 39

5.17.1 Daktari Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 39

5.18 Diagnostics For All Inc Company Overview 40

5.18.1 Diagnostics For All Inc Pipeline Products & Ongoing Clinical Trials Overview 40

5.19 Diagnostics for the Real World (Europe) Ltd Company Overview 41

5.19.1 Diagnostics for the Real World (Europe) Ltd Pipeline Products & Ongoing Clinical Trials Overview 41

5.20 Endeavor Sciences Inc Company Overview 42

5.20.1 Endeavor Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 42

5.21 Epinex Diagnostics Inc Company Overview 43

5.21.1 Epinex Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.22 ERBA Molecular Ltd Company Overview 44

5.22.1 ERBA Molecular Ltd Pipeline Products & Ongoing Clinical Trials Overview 44

5.23 GAIA Medical Institute LLC Company Overview 45

5.23.1 GAIA Medical Institute LLC Pipeline Products & Ongoing Clinical Trials Overview 45

5.24 genedrive plc Company Overview 46

5.24.1 genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 46

5.25 Group K Diagnostics Company Overview 47

5.25.1 Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 47

5.26 HeatFlow Technologies Inc Company Overview 48

5.26.1 HeatFlow Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 48

5.27 Imperial College London Company Overview 49

5.27.1 Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 49

5.28 Jinvator Bio Med GmbH Company Overview 50

5.28.1 Jinvator Bio Med GmbH Pipeline Products & Ongoing Clinical Trials Overview 50

5.29 Johns Hopkins University Company Overview 51

5.29.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 51

5.30 Labsystems Diagnostics Oy Company Overview 52

5.30.1 Labsystems Diagnostics Oy Pipeline Products & Ongoing Clinical Trials Overview 52

5.31 Micronics Inc Company Overview 53

5.31.1 Micronics Inc Pipeline Products & Ongoing Clinical Trials Overview 53

5.32 Molbio Diagnostics Pvt Ltd Company Overview 55

5.32.1 Molbio Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 55

5.33 Nanobiosym Inc Company Overview 56

5.33.1 Nanobiosym Inc Pipeline Products & Ongoing Clinical Trials Overview 56

5.34 NeuMoDx Molecular Inc Company Overview 57

5.34.1 NeuMoDx Molecular Inc Pipeline Products & Ongoing Clinical Trials Overview 57

5.35 Newmark Diagnostics LLC Company Overview 58

5.35.1 Newmark Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 58

5.36 Northwestern University Company Overview 59

5.36.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 59

5.37 Orangelife Company Overview 60

5.37.1 Orangelife Pipeline Products & Ongoing Clinical Trials Overview 60

5.38 Osel Inc Company Overview 61

5.38.1 Osel Inc Pipeline Products & Ongoing Clinical Trials Overview 61

5.39 QuantuMDx Group Ltd Company Overview 62

5.39.1 QuantuMDx Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 62

5.40 Quidel Corp Company Overview 63

5.40.1 Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 63

5.41 Radisens Diagnostics Ltd Company Overview 64

5.41.1 Radisens Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 64

5.42 Rheonix Inc Company Overview 65

5.42.1 Rheonix Inc Pipeline Products & Ongoing Clinical Trials Overview 65

5.43 Roche Diagnostics International Ltd Company Overview 66

5.43.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 66

5.44 Sedia Biosciences Corp Company Overview 67

5.44.1 Sedia Biosciences Corp Pipeline Products & Ongoing Clinical Trials Overview 67

5.45 TheoremDx Inc Company Overview 69

5.45.1 TheoremDx Inc Pipeline Products & Ongoing Clinical Trials Overview 69

5.46 Trinity Biotech Plc Company Overview 70

5.46.1 Trinity Biotech Plc Pipeline Products & Ongoing Clinical Trials Overview 70

5.47 University of Washington Company Overview 71

5.47.1 University of Washington Pipeline Products & Ongoing Clinical Trials Overview 71

5.48 UrSure Inc Company Overview 72

5.48.1 UrSure Inc Pipeline Products & Ongoing Clinical Trials Overview 72

5.49 Wave 80 Biosciences Inc Company Overview 73

5.49.1 Wave 80 Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 73

5.50 Yaathum Biotech Pvt Ltd Company Overview 75

5.50.1 Yaathum Biotech Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 75

6 Retrovirus Rapid Tests & Point of Care (POC) – Recent Developments 76

6.1 Nov 04, 2019: Chembio Diagnostics receives WHO Prequalification Approval for HIV Self-Test 76

6.2 Oct 30, 2019: Quidel reports third quarter 2019 financial results 76

6.3 Oct 17, 2019: Chembio Diagnostics receives WHO prequalification approval for Malaysia facility 78

6.4 Oct 16, 2019: Trinity Biotech announces results for Q3, 2019 78

6.5 Oct 15, 2019: Johnson & Johnson reports 2019 Third-Quarter Results 80

6.6 Sep 30, 2019: Johnson & Johnson appoints Carlton Lawson to area Managing Director, Consumer, Northern Europe 81

6.7 Sep 19, 2019: INSTI now available for expanded point-of-care use in Canada 81

6.8 Sep 16, 2019: Omega Diagnostics Group: Update on VISITECT CD4 Advanced Disease 82

6.9 Sep 05, 2019: Biocartis announces H1 2019 results 83

6.10 Aug 20, 2019: First purchase order for VISITECT CD4 advanced disease test 88

6.11 Aug 20, 2019: Trinity Biotech announces results for Q2, 2019 88

6.12 Aug 08, 2019: Quidel reports second quarter 2019 Financial Results 90

6.13 Aug 01, 2019: Generex Biotechnology welcomes MediSource Partners to the NuGenerex Family of Companies 92

6.14 Jul 16, 2019: Johnson & Johnson reports 2019 Second-Quarter Results 92

6.15 Jun 26, 2019: OraSure Technologies and others join forces for HIV Testing Day 94

6.16 Jun 14, 2019: Drug Makers Sue to Block requirement for Listing Prices in TV Ads 94

6.17 May 15, 2019: Johnson & Johnson outlines strategy to deliver above-market growth at 2019 pharmaceutical business review 94

6.18 May 08, 2019: Quidel reports first quarter 2019 financial results 95

6.19 May 07, 2019: Trinity Biotech announces results for Q1, 2019 96

6.20 May 02, 2019: Abbott receives WHO Prequalification approval for breakthrough HIV Point-of-Care Test 98

6.21 Apr 25, 2019: Biocartis Group Q1 2019 Business Update 99

6.22 Apr 16, 2019: Johnson & Johnson reports 2019 first-quarter results 102

6.23 Mar 18, 2019: CE-Mark for VISITECT CD4 Advanced Disease test 103

6.24 Mar 07, 2019: Trinity Biotech announces quarter 4 and fiscal year 2018 financial results 104

6.25 Mar 06, 2019: Omega diagnostics provides update on VISITECT CD4 106

6.26 Feb 28, 2019: Biocartis announces 2018 results and 2019 outlook 107

6.27 Feb 13, 2019: Quidel Reports Fourth Quarter and Full Year 2018 Financial Results 112

6.28 Feb 08, 2019: Johnson & Johnson to disclose drug prices in television ads 113

6.29 Jan 29, 2019: Omega Diagnostics Group: VISITECT CD4 Advanced Disease test update 114

6.30 Jan 22, 2019: Johnson & Johnson reports 2018 fourth-quarter results 115

6.31 Jan 07, 2019: Biocartis announces achieving its 2018 key business objectives 117

6.32 Jan 07, 2019: Quidel Announces Preliminary Revenue for Fourth Quarter 2018 118

6.33 Jan 07, 2019: Biocartis announces achieving its 2018 key business objectives 118

7 Appendix 120

7.1 Methodology 120

7.2 About GlobalData 123

7.3 Contact Us 123

7.4 Disclaimer 123

List of Tables

Table 1: Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Stage of Development 10

Table 2: Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Territory 11

Table 3: Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Regulatory Path 12

Table 4: Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Estimated Approval Date 13

Table 5: Retrovirus Rapid Tests & Point of Care (POC) Companies – Pipeline Products by Stage of Development 14

Table 6: Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Stage of Development 16

Table 7: Access Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 18

Table 10: Akers Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 19

Table 13: Aldatu Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 20

Table 16: Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 21

Table 19: Altratech Ltd Pipeline Products & Ongoing Clinical Trials Overview 22

Table 22: BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 23

Table 25: Beijing Wantai Biological Pharmacy Enterprise Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 24

Table 28: Binx Health Inc Pipeline Products & Ongoing Clinical Trials Overview 25

Table 31: Bio-AMD Inc Pipeline Products & Ongoing Clinical Trials Overview 26

Table 34: Biocartis Group NV Pipeline Products & Ongoing Clinical Trials Overview 27

Table 37: BioHelix Corp Pipeline Products & Ongoing Clinical Trials Overview 28

Table 42: Calypte Biomedical Corporation Pipeline Products & Ongoing Clinical Trials Overview 30

Table 47: Centre International de Reference Chantal Biya Pipeline Products & Ongoing Clinical Trials Overview 32

Table 50: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 33

Table 55: Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 35

Table 62: CrossLife Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 38

Table 65: Daktari Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 39

Table 68: Diagnostics For All Inc Pipeline Products & Ongoing Clinical Trials Overview 40

Table 71: Diagnostics for the Real World (Europe) Ltd Pipeline Products & Ongoing Clinical Trials Overview 41

Table 74: Endeavor Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 42

Table 77: Epinex Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Table 80: ERBA Molecular Ltd Pipeline Products & Ongoing Clinical Trials Overview 44

Table 83: GAIA Medical Institute LLC Pipeline Products & Ongoing Clinical Trials Overview 45

Table 86: genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 46

Table 89: Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 47

Table 92: HeatFlow Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 48

Table 95: Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 49

Table 98: Jinvator Bio Med GmbH Pipeline Products & Ongoing Clinical Trials Overview 50

Table 101: Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 51

Table 104: Labsystems Diagnostics Oy Pipeline Products & Ongoing Clinical Trials Overview 52

Table 107: Micronics Inc Pipeline Products & Ongoing Clinical Trials Overview 53

Table 112: Molbio Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 55

Table 115: Nanobiosym Inc Pipeline Products & Ongoing Clinical Trials Overview 56

Table 118: NeuMoDx Molecular Inc Pipeline Products & Ongoing Clinical Trials Overview 57

Table 121: Newmark Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 58

Table 124: Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 59

Table 127: Orangelife Pipeline Products & Ongoing Clinical Trials Overview 60

Table 130: Osel Inc Pipeline Products & Ongoing Clinical Trials Overview 61

Table 133: QuantuMDx Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 62

Table 136: Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 63

Table 139: Radisens Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 64

Table 142: Rheonix Inc Pipeline Products & Ongoing Clinical Trials Overview 65

Table 145: Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 66

Table 148: Sedia Biosciences Corp Pipeline Products & Ongoing Clinical Trials Overview 67

Table 153: TheoremDx Inc Pipeline Products & Ongoing Clinical Trials Overview 69

Table 156: Trinity Biotech Plc Pipeline Products & Ongoing Clinical Trials Overview 70

Table 159: University of Washington Pipeline Products & Ongoing Clinical Trials Overview 71

Table 162: UrSure Inc Pipeline Products & Ongoing Clinical Trials Overview 72

Table 165: Wave 80 Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 73

Table 170: Yaathum Biotech Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 75

Table 173: Glossary 122

List of Figures

Figure 1: Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Stage of Development 10

Figure 2: Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Territory 11

Figure 3: Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Regulatory Path 12

Figure 4: Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Estimated Approval Date 13

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