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Diagnostics |
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Point of Care Diagnostic Testing Sector Trends
Publication Date April 2006
Publisher TriMark Publications
Product Type Strategic Report
Pages 163
ISBN Number TMRPOCST06-0415
Product Code TRI028
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Summary
The purpose of this report is to describe the sector trends within the point of care testing (POCT) diagnostic market. It examines those measurement devices and their reagents and supplies that are utilized in hospitals, clinics, commercial laboratories and research institutions to detect cells and proteins for the purpose of diagnosis and monitoring of disease. This study includes all of the generally-accepted clinical analytical activities that are currently in use today. Additionally, an analysis of business and technology trends and developing areas of point of care and HPV testing is provided, along with a review of the market for point of care testing equipment and supplies in the clinical and research market segments, using screening reagents and instruments for analysis of individual components in blood, serum or plasma. This report defines U.S. and global market dollar sales volume and analyzes factors that influence the size and growth of market segments.
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Content
- 1. Overview
- 1.1 About this Report
- 1.2 Scope of the Report
- 1.3 Objectives
- 1.4 Methodology
- 1.5 Executive Summary
- 2. Overview of Diagnostic Testing Point of Care
- 3. POC and Rapid Testing: Market Analysis: Size, Background Analysis, Growth, Share and Competitors
- 3.1 Global POCT Market
- 3.2 U.S. POC Markets
- 3.3 European POCT Market
- 3.3.1 German Point of Care Diagnostic Markets
- 3.3.2 U.K. POCT Diagnostic Market
- 3.3.2.1 U.K. Market Statistics
- 3.3.2.2 U.K. Competitive Analysis
- 3.3.2.3 U.K. Market Access
- 3.3.3 French Point of Care Diagnostic Market
- 3.3.4 Italian POC Diagnostic Market
- 3.3.5 Spanish POC Diagnostic Market
- 3.3.6 Scandinavian Point of Care Market
- 3.4 Japanese POCT Market
- 3.5 Country Point of Care Smaller Markets
- 3.5.1 Chinese Point of Care Market
- 3.5.2 Canada Point of Care Market
- 3.5.3 Brazil Point of Care Market
- 3.5.4 Turkey Point of Care Market
- 3.5.5 Australia Point of Care Market
- 3.6 Rest of the World POCT Market
- 3.6.1 Overview of Asian Healthcare Market
- 3.6.2 Singapore
- 3.6.3 Malaysia
- 3.6.4 Thailand
- 3.6.5 Indonesia
- 3.6.6 Philippines
- 3.6.7 South Korea
- 3.6.8 India
- 3.6.9 Taiwan
- 4. POCT Individual Markets
- 4.1 Glucose Testing
- 4.2 POCT Individual Market Sectors, Size, Growth Rates and Competitors
- 4.2.1 U.S. Market
- 4.2.2 European Market
- 4.2.3 Alternate Glucose Monitoring Products
- 4.3 Blood Gas and Electrolytes
- 4.4 Rapid Coagulation Tests
- 4.4.1 U.S. Coagulation Market
- 4.4.2 European Coagulation Market
- 4.5 Rapid Cardiac Markers
- 4.5.1 American Market
- 4.5.2 European Market
- 4.6 Drugs of Abuse Screening Testing
- 4.6.1 Acetaminophen
- 4.6.2 TriCyclic Antidepressants
- 4.6.3 Other Toxic Drugs
- 4.6.4 Drug Testing Selectivity
- 4.6.5 Methaqualone and Phencyclidine (PCP)
- 4.6.6 Tetrahydrocannabinol
- 4.6.7 Drug Panels by Toxidromes
- 4.6.8 Alcohol Testing
- 4.7 Urine Strips
- 4.8 Pregnancy Tests
- 4.9 Fecal Occult Blood
- 4.10 Hemoglobin Testing
- 4.11 Miscellaneous Rapid Tests
- 4.11.1 Estriol
- 4.11.2 Fetal Fibrinectin (fFN)
- 4.11.3 H. pylori
- 4.11.4 Vaginal pH and Vaginitis
- 4.11.5 Bladder Cancer
- 4.11.6 Fetal Status
- 4.12 HIV
- 4.13 Cholesterol
- 4.14 Infectious Disease
- 4.14.1 C. difficile
- 4.14.2 Giardia
- 4.14.3 Salmonella
- 4.14.4 Malaria Testing
- 4.14.5 Influenza Testing
- 4.14.6 Strep Testing
- 4.14.7 Chlamydia
- 4.14.8 Mononucleosis
- 4.14.9 Rubella
- 4.14.10 Staphylococcus Aurea
- 4.14.11 Hepatitis
- 4.14.12 Gonorrhea
- 4.14.13 Tuberculosis (TB)
- 4.15 Infant Jaundice
- 4.16 Anthrax
- 5. POCT: Reagents and Equipment
- 5.1 Blood Glucose Monitoring
- 5.2 Blood Gas and Electrolytes
- 5.2.1 Optical Sensors
- 5.2.2 Roche Corp.
- 5.2.3 Diametrics
- 5.2.4 Bayer
- 5.2.5 Instrumentation Laboratory
- 5.2.6 Nova Biomedical
- 5.2.7 Radiometer
- 5.2.8 Abbott (i-STAT Corporation)
- 5.2.9 Avox Systems
- 5.2.10 Disetronic Medical Systems
- 5.2.11 Nova
- 5.2.12 Abbott
- 5.2.13 ITC
- 5.2.14 Osmetech
- 5.2.15 Span Diagnostics
- 5.3 Rapid Coagulation Tests
- 5.3.1 POC Coagulation Instrument Description
- 5.3.1.1 Roche Diagnostics Corp.
- 5.3.1.2 Abbott i-STAT
- 5.3.1.3 International Technidyne Corp.
- 5.3.1.4 Medtronic Cardiac Surgery
- 5.3.1.5 LifeScan
- 5.3.1.6 Instrumentation Laboratory
- 5.3.1.7 Hemosense
- 5.3.1.8 Helena Point of Care
- 5.3.1.9 Bayer
- 5.3.1.10 Beckman Coulter
- 5.3.1.11 Pharmanetics (Cardiovascular Diagnostics)
- 5.3.1.12 Sienco
- 5.3.2 Connectivity Issues
- 5.3.3 Cost Benefits
- 5.3.4 Quality Control Issues
- 5.3.5 Certification for POC Coagulation Devices
- 5.3.6 Systems for ACT
- 5.4 Rapid Cardiac Markers
- 5.4.1 Spectral Diagnostics
- 5.4.2 Biosite Diagnostics
- 5.4.3 Roche Diagnostics
- 5.4.4 First Medical
- 5.4.5 Ani Biotech
- 5.4.6 Response Biomedical
- 5.4.7 Dade Behring
- 5.4.8 SYNX Pharma, Inc.
- 5.4.9 Ark Therapeutics Ltd.
- 5.4.10 Abbott (i-STAT Corp.)
- 5.4.11 LifeSign
- 5.4.12 Mitsubishi Kagaku Iatron
- 5.5 Rapid Drugs of Abuse
- 5.5.1 Biosite Diagnostics
- 5.5.2 Point of Care Technologies
- 5.5.3 Abbott Diagnostics
- 5.5.4 Roche Diagnostics
- 5.5.5 BioScan Screening Systems, Inc.
- 5.5.6 American Bio Medica Corp.
- 5.5.7 Pharmatech Corporation
- 5.5.8 Worldwide Medical
- 5.5.9 Syva Dade Behring
- 5.5.10 STC Technologies, Inc.
- 5.5.11 Dynagen, Inc.
- 5.5.12 Orasure
- 5.5.13 LifePoint
- 5.5.14 Avitar, Inc.
- 5.5.15 Cozart Biosciences
- 5.5.16 GDS
- 5.5.17 Securetec
- 5.6 Urine Strips
- 5.7 Rapid Pregnancy and Fertility Tests
- 5.8 Fecal Occult Blood
- 5.8.1 Helena Laboratories
- 5.8.2 Biomerica
- 5.8.3 Beckman Coulter
- 5.8.4 Wampole Laboratories
- 5.8.5 Worldwide Medical
- 5.8.6 Aerscher Diagnostics
- 5.8.7 Enterix
- 5.8.8 Medix Biochemica
- 5.9 Hemoglobin Testing
- 5.9.1 Wampole Laboratories
- 5.9.2 HemoCue, Inc.
- 5.9.3 Micro Diagnostics Corporation
- 5.9.4 GDS Technology
- 5.10 Miscellaneous Rapid Tests
- 5.10.1 Triage C. difficile Panel
- 5.10.2 Ketoacids
- 5.10.3 Acetaminophen
- 5.10.4 Estriol
- 5.10.5 H. pylori
- 5.10.6 Vaginal Fluid pH and Vaginitis
- 5.10.7 PSA
- 5.10.8 Bladder Cancer
- 5.10.9 Other Rapid Cancer Tests
- 5.10.10 Fetal Status
- 5.10.11 Osteoporosis
- 5.11 HIV
- 5.12 Cholesterol
- 5.12.1 Cholestech
- 5.12.2 Lifestream Diagnostics
- 5.12.3 Actimed Laboratories
- 5.12.4 Stat Site Meter
- 5.12.5 Polymer Technology Systems
- 5.12.6 International Medical Innovations Inc. (IMI)
- 5.13 Infectious Disease
- 5.13.1 C. difficile
- 5.13.2 Giardia
- 5.13.3 Dengue Fever
- 5.13.4 Malaria Testing
- 5.13.5 Rapid Influenza Testing
- 5.13.6 Streptococcus Testing
- 5.13.7 Chlamydia
- 5.13.8 Mononucleosis
- 5.13.9 Rubella
- 5.13.10 Staphylococcus
- 5.13.11 Hepatitis
- 5.13.12 E. coli 0157
- 5.13.13 Gonorrhea Testing
- 5.13.14 Small Pox
- 5.13.15 SARS
- 5.13.16 Rabies
- 5.13.17 Tuberculosis
- 5.13.18 Avian Flu
- 5.14 Infant Jaundice
- 5.15 Anthrax
- 5.16 Homeland Defense
- 5.17 BSE
- 5.18 Tuberculosis
- 6. POCT: Growth Regulators
- 6.1 Moderators of Growth
- 6.2 Personnel Acceptance
- 6.3 Key People for POCT
- 6.4 Information Management Issues
- 6.4.1 Elements of Information Management for POCT: Information Processing Capabilities
- 6.4.2 Data Mining
- 6.4.3 Middleware
- 6.4.4 Web Portals
- 6.4.5 POCT-1A Standard
- 6.5 Key Elements for POCT
- 6.6 POCT and Reimbursement
- 6.7 Effectiveness of Clinical Outcomes
- 6.8 Rapid Near Patient Testing in Hospitals
- 6.9 Satellite Facilities
- 6.10 Regionalization of Laboratory Care
- 6.11 Requirements for POCT
- 6.12 Locations of Point of Care for Patient Care
- 6.13 Benefits of POCT
- 6.14 TAT for POCT
- 6.15 Clinical Laboratory Improvement Amendments (CLIA)
- 7. Business Trends in the Point of Care Sector
- 7.1 Sector Consolidation
- 7.2 Diagnostic Testing Growth Trends
- 7.3 Acquisition, License Agreements, Internal Development, Partnerships
- 7.4 Product Testing Depth in POCT
- 7.5 Government Regulation
- 7.5.1 U.S. Regulation
- 7.5.1.1 Importing Medical Devices into the U.S.
- 7.5.1.2 Exporting Medical Devices from the U.S.
- 7.5.2 U.K. Regulation
- 7.5.3 E.U. Regulation
- 7.5.3.1 French Regulation
- 7.5.4 Japanese Regulation
- 7.5.5 Korean Regulation
- 7.6 Increased Market Penetration
- 7.7 Costs of Doing Business in Europe
- 7.8 Drivers of European Diagnostics Testing
- 7.9 European Reimbursement Practices
- 7.10 Cost Containment in Europe
- 8. Technology Platform Innovations in POCT
- 8.1 Sensor Systems for Diagnostic Applications
- 8.2 Glucose Measurements
- 8.3 Glucose Test Methods
- 8.4 Cholesterol Testing
- 8.5 The New Paradigm
- 8.6 Consolidated Workstations and Modularity
- 8.7 Automation and Robotics in the Clinical Laboratory
- 8.8 Laboratory Information Systems (LIS)
- 8.9 Biosensor Technology
- 9. Data Management and Connectivity
- 9.1 Wireless LANs
- 9.2 Connectivity Platforms
- 9.2.1 DataLink Data Management System
- 9.2.2 RALS-Plus
- 9.2.3 LabPortal.com
- 9.3 Advantages of POCT Connectivity
- 10. Corporate Profiles
- 10.1 Abaxis, Inc.
- 10.2 Abbott Diagnostics
- 10.3 Accumetrics, Inc.
- 10.4 Accurex Biomedical, Pvt., Ltd.
- 10.5 ActiMed Diagnostics
- 10.6 Adeza Biomedical Corporation
- 10.7 Akers Bioscience
- 10.8 Ambri Ltd.
- 10.9 American Biogenetic Sciences, Inc.
- 10.10 American Bio Medica Corp.
- 10.11 Ani Biotech
- 10.12 Apogent Technologies
- 10.13 Ark Therapeutics
- 10.14 Array Medical
- 10.15 Avitar, Inc.
- 10.16 Avox Systems
- 10.17 Axis-Shield
- 10.18 Bayer Corporation
- 10.19 Beacon Diagnostics
- 10.20 Beckman Coulter
- 10.21 Biex Inc.
- 10.22 Binax Corporation
- 10.23 Biomerica
- 10.24 BioMrieux Vitek, Inc.
- 10.25 BioScan Screening Systems, Inc.
- 10.26 Biosite Diagnostics
- 10.27 BioStar
- 10.28 Bio-Warm Corporation
- 10.29 Caliper Life Sciences
- 10.30 Calypte Biomedical
- 10.31 Cardiovascular Diagnostics
- 10.32 Chembio Diagnostics
- 10.33 ChemTrak
- 10.34 Cholestech
- 10.35 Chongqing Sungene Pharmaceutical Co., Ltd.
- 10.36 Compucyte Corporation
- 10.37 Cortech Ltd.
- 10.38 Cozart Biosciences
- 10.39 Cygnus Therapeutic Systems
- 10.40 Cytogen
- 10.41 Dade Behring
- 10.42 Daiichi Co., Ltd.
- 10.43 Denka Seiken Co., Ltd.
- 10.44 Diagnology, Inc.
- 10.45 Diametrics Medical, Inc.
- 10.46 Ely Labs
- 10.47 Enterix, Inc.
- 10.48 First Medical, Inc.
- 10.49 GDS Technology
- 10.50 GenBio
- 10.51 Genzyme Diagnostics
- 10.52 Grant Life Sciences
- 10.53 Gryphus Diagnostics
- 10.54 Helena Laboratories
- 10.55 Hema Diagnostic Systems
- 10.56 Hemocue, Inc.
- 10.57 Home Access Health Corp.
- 10.58 i-STAT Corporation
- 10.59 Instrumentation Laboratory
- 10.60 International Medical Innovations
- 10.61 Inverness Medical Innovations
- 10.62 Immunoscience, Inc.
- 10.63 Jiangnan Biotech
- 10.64 Johnson & Johnson
- 10.65 Kyowa Medex Co., Ltd.
- 10.66 LifeAssays
- 10.67 LifePoint, Inc.
- 10.68 LifeScan Corporation
- 10.69 Lifestream Technologies
- 10.70 LXN Corp. (Inverness Medical Technologies)
- 10.71 Matritech
- 10.72 Medical Services International Inc.
- 10.73 MediSense
- 10.74 Medisys
- 10.75 Medix Biochemica
- 10.76 MedMira Laboratories
- 10.77 Meretek Corporation
- 10.78 Meridian Bioscience
- 10.79 MiniMed
- 10.80 Mitsubishi Chemical America, Inc.
- 10.81 Mitsubishi Kagaku Iatron
- 10.82 Nanogen
- 10.83 New Horizons Diagnostics
- 10.84 Nova Diagnostics
- 10.85 Optical Sensors Inc.
- 10.86 Orasure
- 10.87 Orgenics
- 10.88 Orion Diagnostica
- 10.89 PanBio Corp.
- 10.90 PharmaNetics, Inc.
- 10.91 Pharmatech Corporation
- 10.92 Phillips Medical Systems
- 10.93 Point of Care Technologies
- 10.94 Polymedco
- 10.95 Polymer Technology Systems
- 10.96 Princeton BioMeditech Corporation
- 10.97 Quidel
- 10.98 Radiometer
- 10.99 Response Biomedical Corp.
- 10.100 Roche Diagnostics
- 10.101 Royal Philips Electronics
- 10.102 Saliva Diagnostics
- 10.103 Savyon Diagnostics
- 10.104 Selfcare, Inc.
- 10.105 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech)
- 10.106 Shionogi & Co., Ltd.
- 10.107 SpectRx, Inc.
- 10.108 Spectral Diagnostics
- 10.109 STC Technologies
- 10.110 Sun Biomedical Laboratories
- 10.111 Sybron International Corporation
- 10.112 Taiwan Diagnostic
- 10.113 TCPI
- 10.114 Therasense, Inc.
- 10.115 Thermo Biostar
- 10.116 Thoratec/International Technidyne Corp.
- 10.117 Transmedica
- 10.118 Trinity Biotech
- 10.119 Wampole Laboratories
- 10.120 Worldwide Medical Corporation
- 11. POCT Sector Trends and Forecasts
- 12. Corporate Directory
- Index Of Tables
- Table 2.1: POC Testing
- Table 3.1: Number of ER Visits in U.S. Hospitals, 1996-2005
- Table 3.2: Number of Point of Care Tests in U.S., 2000-2011
- Table 3.3: The Overall In Vitro Diagnostic Testing Market Worldwide, 2005
- Table 3.4: Worldwide Distribution of IVD Testing, 2005
- Table 3.5: Top Twelve Country IVD Testing Markets, 2005
- Table 3.6: Ten Largest Diagnostic Companies Worldwide, 2005
- Table 3.7: Global Point of Care Revenues, 1998-2008
- Table 3.8: Worldwide Distribution of POCT, 2005
- Table 3.9: U.S. POCT Market, 2000-2011
- Table 3.10: U.S. Clinical Diagnostic Test Market Segments, Revenue from Clinical Laboratory Testing, 2005
- Table 3.11: U.S. POCT by Distribution Location, 2005
- Table 3.12: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2005
- Table 3.13: Drivers of European Diagnostics Testing
- Table 3.14: Regional Comparison of Healthcare and IVD for Eastern Europe
- Table 3.15: European POCT Market, 2000-2008
- Table 3.16: European POCT Diagnostics Market, 2004
- Table 3.17: Top Twelve Country IVD Testing Markets and POC Share, 2005
- Table 3.18: German POCT Diagnostics Products Market Sales, 2002-2007
- Table 3.19: The German Patient Care Central Lab Test Market, 2000-2008
- Table 3.20: The German Alternate Site Testing Market (POL), 2000-2008
- Table 3.21: The German Hospital POC Market, 2000-2008
- Table 3.22: German Clinical Diagnostic Test Market Segments, Revenue from Clinical Laboratory Testing, 2004
- Table 3.23: German Clinical Diagnostic Rapid Test Market Segments, 2001
- Table 3.24: U.K. POC Diagnostics Products Market Sales, 1998-2007
- Table 3.25: Major U.K. IVD Manufacturers
- Table 3.26: U.S. IVD Manufacturers Doing Business in the U.K.
- Table 3.27: Other European Companies that Manufacture IVD Products in the U.K.
- Table 3.28: French POC Diagnostics Products Market Sales, 1998-2007
- Table 3.29: Italian POC Diagnostics Products Market Sales, 1998-2007
- Table 3.30: Spanish POC Diagnostics Products Market Sales, 1998-2007
- Table 3.31: Scandinavian POC Diagnostics Products Market Sales, 2000-2008
- Table 3.32: Japan POCT Market, 2000-2008
- Table 3.33: Chinese Point of Care Diagnostics Products Market Sales, 2000-2008
- Table 3.34: Canadian POCT Market, 2000-2008
- Table 3.35: Brazilian POCT Market, 2000-2008
- Table 3.36: Turkish POCT Market, 2000-2008
- Table 3.37: Australian POCT Market, 2000-2008
- Table 3.38: The ROW POCT Market, 2000-2007
- Table 4.1: World Market Share of Point of Care Glucose Monitoring Marketers
- Table 4.2: The Global Population of Persons with Diabetes, 1995 and 2025
- Table 4.3: U.S. Point of Care Glucose Testing Market, 1997-2011
- Table 4.4: Manufacturer Market Share U.S. POCT Market, 2005
- Table 4.5: Rapid Testing U.S. Market Share for Blood Glucose Testing Segment
- Table 4.6: The Blood Gas and Electrolyte Market for POCT in the U.S., 2001-2011
- Table 4.7: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 2005
- Table 4.8: The Coagulation Market for POCT in the U.S., 2001-2011
- Table 4.9: The POC Prothrombin Market for POCT in the U.S., 2000-2007
- Table 4.10: The Cardiac Marker Market for POCT in the U.S., 2001-2011
- Table 4.11: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2005
- Table 4.12: The Cardiac Marker Market for POCT in Europe, 2001-2011
- Table 4.13: U.S. Point of Care Drugs of Abuse Testing Market, 2001-2011
- Table 4.14: Global Point of Care Urine Test Strip Testing Market, 2001-2007
- Table 4.15: U.S. Point of Care Urine Test Strip Testing Market, 2001-2011
- Table 4.16: U.S. Point of Care Urine Test Strip Testing Market Share
- Table 4.17: Medicare Fee Schedule for Urine Chemistry Testing
- Table 4.18: U.S. Point of Care Pregnancy Testing Market, 2001-2007
- Table 4.19: International Point of Care Pregnancy Testing Markets, 2001-2007
- Table 4.20: U.S. Market Share for Rapid Point of Care Pregnancy Tests
- Table 4.21: Number of HIV Tests Performed in Europe, 1997-2001
- Table 4.22: U.S. POCT Market for HIV, 2001-2008
- Table 4.23: Countries with the Highest Prevalence of HIV/AIDS
- Table 4.24: Births of HIV Infected Babies in U.S., 1991-2001
- Table 4.25: Worldwide Point of Care Influenza Testing Market, 2002-2007
- Table 4.26: U.S. Point of Care Influenza Testing Market, 2002-2007
- Table 4.27: International Point of Care Influenza Testing Markets, 2002-2007
- Table 4.28: U.S. Market for Rapid Point of Care Influenza Tests
- Table 4.29: Worldwide Point of Care Strep A Testing Market, 2002-2007
- Table 4.30: U.S. Point of Care Strep A Testing Market, 2002-2007
- Table 4.31: International Point of Care Strep A Testing Markets, 2002-2007
- Table 4.32: U.S. Market for Rapid Point of Care Strep Tests
- Table 4.33: Global Market for Chlamydia Diagnostic Testing, 2000-2009
- Table 4.34: U.S. Market for Chlamydia Diagnostic Testing, 2000-2009
- Table 4.35: Global Market for Gonorrhea Diagnostic Testing, 2000-2009
- Table 4.36: Global Market for TB Diagnostic Testing, 2000-2008
- Table 4.37: U.S. Anthrax Test Market
- Table 5.1: Type of Test: Lateral Flow
- Table 5.2: Type of Test: Flow-Through
- Table 5.3: Type of Test: Agglutination
- Table 5.4: Type of Test: Immunoblot
- Table 6.1: ER Admissions in the U.S., 1997-2001
- Table 6.2: Access Points and Desktop Adapters
- Table 6.3: POCT Clinical Outcomes in Diabetic Ketoacidosis
- Table 6.4: POCT Clinical Outcomes in Arterial Blood Gas Measurements
- Table 6.5: POCT in Three Hospitals Cost Analysis with Labor Included
- Table 6.6: Cost Analysis for Glucose Testing: POCT vs. Central Lab
- Table 6.7: Financial Comparison for Moderate and Waived CLIA Labs
- Table 8.1: Normal Glucose Values-Fasting State
- Table 9.1: Applications for Wireless LAN Technology
- Table 9.2: Wireless LAN Technology Companies
- Table 9.3: Customized Reports Must Support CAP and JCAHO Requirements
- Table 9.4: RALS-Plus Point of Care Market Share
- Table 9.5: Applications of RALS Connectivity with POCT Devices
- Table 10.1: Products Marketed by Abbott in the Diagnostic Market
- Table 10.2: Quidel Product Sales Distribution, 2003
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