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3. Additional resources for selecting and implementing informatics solutions - Part 2: Other vendors and service providers

3.2 Medical diagnostics instrumentation and equipment vendors

3.2.1 CLIA-certified vendors

Medical diagnostics laboratories perform various types of testing, including point-of-care testing. At least in the United States, the Clinical Laboratory Improvement Amendments (CLIA) test complexities, as determined by the U.S. Food & Drug Administration (FDA), and resulting public CLIA Database provide insight into the instrumentation and equipment vendors marketing equipment for diagnostic and research laboratories. While not a complete list of instrument and equipment vendors, the CLIA-approved vendor lists below make an excellent starting point for laboratories seeking to add to its testing inventory.

The following two tables list vendors verified to sell CLIA-waived instruments and/or test kits. CLIA-waived instruments and test kits are deemed as being simple to use and as having little chance in providing wrong information or harming someone. The vendors were pulled from the FDA's downloadable CLIA file from January 2020. The file was sorted to pull out the CLIA-waived devices, and then the vendors were researched to see if they still actively marketed the listed product(s). In some cases, the vendor listed on the FDA file was acquired by another company. If the associated products were still found to be marketed by the acquiring company, that company name was used. CLIA-waived device and test kit types are given as a general guide to what CLIA-waived items the vendor offers.

Note: Do not assume that just because a vendor is listed here all of its offerings are CLIA-waived. Some of these vendors may also sell analyzers and tests that are CLIA-certified as moderate or complex, as well as a variety of other non-CLIA-certified solutions. Additionally, this listing does not name the specific CLIA-waived item(s). It is ultimately up to the potential buyer to verify with the vendor that a specific item is CLIA-waived before purchase.

Vendors of CLIA-waived Instruments and Devices Original manufacturer Testing domain(s) covered Device type(s) Abaxis, Inc. clinical chemistry chemistry analyzers Abbot Diabetes Care clinical chemistry blood glucose monitors Abbot Point of Care clinical chemistry, hematology blood analyzers, chemistry analyzers, hematology devices, molecular immunoassay analyzer ACON Laboratories, Inc. clinical chemistry, hematology, urinalysis blood glucose monitors, hematology devices, urine analyzers Advocate Meters, Inc. clinical chemistry blood glucose monitors AgaMatrix, Inc. clinical chemistry blood glucose monitors All Medicus Co., Ltd. clinical chemistry blood glucose monitors Alliance International Co., Ltd. clinical chemistry blood glucose monitors AmVenturex, Inc. clinical chemistry blood ketone monitors American Screening Corp. clinical chemistry blood glucose monitors Andon Health Co., Ltd. clinical chemistry blood glucose monitors Apex Biotechnology Corp. clinical chemistry blood glucose monitors, blood ketone monitors Applied Biomedical, LLC clinical chemistry blood glucose monitors Arkray USA, Inc. clinical chemistry blood glucose monitors, chemistry analyzers Ascensia Diabetes Care Holdings AG clinical chemistry blood glucose monitors Athelas, Inc. hematology hematology devices Becton Dickson and Company immunology digital immunoassay analyzer Bigfoot Biomedical, Inc. clinical chemistry blood glucose monitors binx health, Inc. immunology molecular immunoassay analyzer BioLand Technology Ltd. clinical chemistry blood glucose monitors Bionime Corporation clinical chemistry blood glucose monitors BioSys Laboratories, Inc. urinalysis urine analyzers BioTelemetry, Inc. clinical chemistry blood glucose monitors Biotron Diagnostics, Inc. clinical chemistry blood glucose monitors Bonraybio Co., Ltd. miscellaneous fertility monitor (male) Bruno Pharma Innovations, LLC clinical chemistry blood glucose monitors, blood ketone monitors BTNX, Inc. clinical chemistry, urinalysis blood glucose monitors, urine analyzers Cambridge Sensors Ltd. clinical chemistry blood glucose monitors Cardinal Health, Inc. urinalysis urine analyzers CGETC, Inc. clinical chemistry blood glucose monitors Clarity Diagnostics, LLC clinical chemistry, hematology, urinalysis blood glucose monitors, hematology devices, urine analyzers CoaguSense, Inc. hematology hematology devices DELBio, Inc. clinical chemistry blood glucose monitors Diathrive, Inc. clinical chemistry blood glucose monitors EKF Diagnostics Holding Plc clinical chemistry, hematology blood glucose monitors, blood ketone monitors, hematology devices Empecs Medical Co., Ltd. clinical chemistry blood glucose monitors EPS Bio Technology Corp. clinical chemistry blood glucose monitors Fifty 50 Medical, Inc. clinical chemistry blood glucose monitors FirstVitals Health and Wellness, Inc. clinical chemistry blood glucose monitors ForaCare, Inc. clinical chemistry blood glucose monitors General Life Biotechnology Co., Ltd. clinical chemistry blood glucose monitors Germaine Laboratories, Inc. clinical chemistry, urinalysis blood cholesterol monitors, blood glucose monitors, urine analyzers GL Diabetes, LLC clinical chemistry blood glucose monitors Gluco Perfect, Inc. clinical chemistry blood glucose monitors Greater Goods, LLC clinical chemistry blood glucose monitors GreenCross Medis Corp. clinical chemistry blood glucose monitors HemoCue AB clinical chemistry, hematology blood glucose monitors, hematology devices Henry Schein, Inc. urinalysis urine analyzers HMD Biomedical, Inc. clinical chemistry blood glucose monitors Home Aide Diagnostics, Inc. clinical chemistry blood glucose monitors Hummingbird Medical, Inc. dba Nurse Rosie Products clinical chemistry blood glucose monitors i-SENS. Inc. clinical chemistry blood glucose monitors, blood ketone monitors iHealth Labs, Inc. clinical chemistry blood glucose monitors ijDream Corporation clinical chemistry blood glucose monitors iLine Microsystems SL hematology hematology devices Infopia Co., Ltd. clinical chemistry blood glucose monitors Intuity Medical, Inc. clinical chemistry blood glucose monitors Jant Pharmacal Corp. hematology hematology devices Joicom Corporation clinical chemistry blood glucose monitors Joinsoon Medical Technology Co., Ltd. hematology hematology devices Keto-Check, Inc. clinical chemistry blood glucose monitors, blood ketone monitors KPI Healthcare, Inc. clinical chemistry blood cholesterol monitors LabStyle Innovations Ltd. clinical chemistry blood glucose monitors LifeScan, Inc. clinical chemistry blood glucose monitors Livongo Health, Inc. clinical chemistry blood glucose monitors Magellan Diagnostics, Inc. clinical chemistry blood analyzers Major Biosystem Co., Ltd. clinical chemistry blood glucose monitors McKesson Medical-Surgical McKesson Medical-Surgical, PSS site clinical chemistry, urinalysis blood glucose monitors, urine analyzers MediVena, LLC clinical chemistry blood glucose monitors Medline Industries, Inc. clinical chemistry, urinalysis blood glucose monitors, urine analyzers Meridian Bioscience, Inc. clinical chemistry blood lead analyzer Mesa Biotech, Inc. immunology digital immunoassay analyzer Metene Limited clinical chemistry blood glucose monitors MHC Medical Products, LLC clinical chemistry blood glucose monitors MiCoBioMed Co., Ltd. clinical chemistry blood glucose monitors MicroTech Medical (Hangzhou) Co., Ltd. clinical chemistry blood glucose monitors Midwest Trading Group, Inc. clinical chemistry blood glucose monitors Nova Biomedical Corp. clinical chemistry blood glucose monitors O2 Lifecare, LLC clinical chemistry blood glucose monitors, blood cholesterol monitors Ok Biotech Co., Ltd. clinical chemistry blood glucose monitors Omnis Health, LLC clinical chemistry blood glucose monitors OptumRx, Inc. clinical chemistry blood glucose monitors Philosys Co., Ltd. clinical chemistry blood glucose monitors Pip Diabetes Care clinical chemistry blood glucose monitors Polymer Technology Systems, Inc. clinical chemistry blood glucose monitors, blood cholesterol monitors POPS! Diabetes Care, Inc. clinical chemistry blood glucose monitors Prodigy Diabetes Care, LLC clinical chemistry blood glucose monitors PTS Diagnostics clinical chemistry, hematology blood glucose monitors, hematology devices Roche Diagnostics clinical chemistry, hematology, urinalysis blood glucose monitors, hematology devices, urine analyzers SD BioSensor, Inc. clinical chemistry blood glucose monitors Separation Technology, Inc. hematology hematology devices Siemens Healthcare GmbH hematology, urinalysis hematology devices, urine analyzers Simple Diagnostics, Inc. clinical chemistry blood glucose monitors Sinocare, Inc. clinical chemistry blood glucose monitors Smart Meter, LLC clinical chemistry blood glucose monitors SMC Direct, LLC clinical chemistry, urinalysis blood glucose monitors, urine analyzers Stanbio Laboratory L.P. hematology, urinalysis hematology devices, urine analyzers Swiss Precision Diagnostics GmbH urinalysis fertility monitor (female) TearLab Corporation clinical chemistry chemistry analyzers Teco Diagnostics, Inc. urinalysis urine analyzers Tenovi Ltd. clinical chemistry blood glucose monitors Trividia Health, Inc. clinical chemistry blood glucose monitors Tyson Bioresearch, Inc. clinical chemistry blood glucose monitors US Diagnostics, Inc. clinical chemistry blood glucose monitors Vidan Diagnostics, LLC clinical chemistry blood glucose monitors, blood ketone monitors Visgeneer, Inc. clinical chemistry blood glucose monitors VivaChek Laboratories, Inc. clinical chemistry blood glucose monitors, blood ketone monitors YD Diagnostics Corp. urinalysis urine analyzers Zenith Diagnostics clinical chemistry blood glucose monitors

Vendors of CLIA-waived Test Kits and Supplies Original manufacturer Testing domain(s) covered Test kit type(s) 1 Step Detect Associates, LLC toxicology drug screen Abbott (formerly Alere/Inverness/Innovacon) immunology, toxicology drug screen, fecal occult, H. pylori, influenza, mono, pregnancy test, Strep A ACON Laboratories, Inc. immunology, toxicology, urinalysis drug screen, H. pylori, mono, ovulation test, pregnancy test, Strep A, urine reagent strips Acro Biotech, Inc. immunology pregnancy test Advin Biotech, Inc. toxicology drug screen Aerscher Diagnostics, LLC immunology fecal occult, gastric occult Ai De Diagnostic Co. immunology pregnancy test Alfa Scientific Designs, Inc. immunology, toxicology, urinalysis drug screen, fecal occult, H. pylori, ovulation test, pregnancy test ALYK, Inc. immunology pregnancy test American Bio Medica Corp. toxicology drug screen American Screening Corp. toxicology drug screen Ameritek USA, Inc. immunology fecal occult, ovulation test, pregnancy test, trichomonas Analyticon Biotechnologies AG urinalysis urine reagent strips Arlington Scientific, Inc. immunology pregnancy test Artron Laboratories, Inc. immunology pregnancy test Assure Tech. (Hangzhou) Co., Ltd. toxicology drug screen Atlas Medical Ltd. immunology pregnancy test Axium BioResearch, Inc. toxicology drug screen Azure Biotech, Inc. immunology pregnancy test Beckman Coulter, Inc. immunology fecal occult, gastric occult, H. pylori, mono, pregnancy test, Strep A Becton Dickson and Company immunology H. pylori, ovulation test, pregnancy test, Strep A Best Value Medical toxicology drug screen Bhat Bio-tech India Private Limited urinalysis urine reagent strips Big Room Testing, LLC toxicology drug screen bioLytical Laboratories, Inc. immunology HIV-1 Biomerica, Inc. immunology fecal occult, ovulation test, pregnancy test bioMérieux SA immunology pregnancy test Biorex Labs, LLC urinalysis urine reagent strips Biotech Screening, LLC toxicology drug screen Biotron Diagnostics, Inc. urinalysis urine reagent strips BTNX, Inc. immunology, toxicology drug screen, fecal occult, FSH, H. pylori, pregnancy test, RSV, Strep A, TSH Cambridge Diagnostic Products, Inc. immunology fecal occult Cardinal Health, Inc. immunology, urinalysis H. pylori, mono, pregnancy test, Strep A, urine reagent strips Cen-Med Enterprises, Inc. immunology fecal occult, pregnancy test Cenogenics Corp. immunology, urinalysis fecal occult, pregnancy test, urine reagent strips Cepheid immunology influenza, Strep A Chain Drug Marketing Association, Inc. urinalysis urine reagent strips Chematics, Inc. toxicology drug screen Chembio Diagnostic Systems, Inc. immunology HIV-1, HIV-2 Chemtron Biotech, Inc. immunology, toxicology drug screen, pregnancy test Church & Dwight Co., Inc. immunology pregnancy test Clarity Diagnostics, LLC immunology, toxicology drug screen, fecal occult, H. pylori, mono, pregnancy test CLIAwaived, Inc. immunology, toxicology, urinalysis drug screen, fecal occult, H. pylori, pregnancy test, Strep A, TSH, urine reagent strips Clinical Genomics Technologies Pty. Ltd. immunology fecal occult Clinical Reference Laboratory, Inc. toxicology drug screen Coastline Medical Management, LLC toxicology drug screen Co-innovation Biotech Co., Ltd. immunology, toxicology drug screen, pregnancy test Common Sense Ltd. immunology vaginal pH Confirm Biosciences toxicology drug screen Coretests, Inc. immunology, toxicology drug screen, pregnancy test Dealmed Medical Supplies, LLC immunology pregnancy test, Strep A Devon Medical Products, Inc. toxicology drug screen DFI Co., Ltd. urinalysis urine reagent strips Diagnostics Direct, LLC immunology syphilis Deus Vult, LLC toxicology drug screen Drug Test City, Inc. toxicology drug screen EASY at Home Medical, LLC immunology, toxicology, urinalysis drug screen, pregnancy test, urine reagent strips EKLA Corporation immunology, toxicology drug screen, pregnancy test Express Diagnostics International, Inc. immunology, toxicology, urinalysis drug screen, pregnancy test, urine reagent strips EZ Testing Solutions, Inc. toxicology drug screen First Check Diagnostics, LLC toxicology drug screen Fisher Healthcare immunology influenza, RSV Germaine Laboratories, Inc. immunology, urinalysis fecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips Get Stix, LLC immunology pregnancy test, urine reagent strips Guangzhou Wondfo Co., Ltd. immunology, toxicology drug screen, pregnancy test Halyard Worldwide, Inc. immunology H. pylori Hangzhou AllTest Biotech Co., Ltd. toxicology drug screen Hangzhou Biotest Biotech Co., Ltd. toxicology drug screen Hangzhou Clongene Biotech Co. Ltd. immunology pregnancy test Hangzhou Sejoy Electronics & Instruments Co. Ltd. immunology pregnancy test Hatty, Inc. urinalysis urine reagent strips Healgen Scientific, LLC immunology, toxicology, urinalysis drug screen, fecal occult, pregnancy test, urine reagent strips Healthy.io Ltd. urinalysis urine reagent strips Helena Laboratories Corp. immunology fecal occult Henry Schein, Inc. immunology, urinalysis fecal occult, H. pylori, influenza, mono, pregnancy test, Strep A, urine reagent strips Heritage House '76 Inc. immunology pregnancy test Home Health UK, Ltd. immunology pregnancy test Hospital Connect, Inc. toxicology drug screen i-Health, Inc. urinalysis urine reagent strips IMCO, Inc. immunology mono, pregnancy test, Strep A, trichomonas Immunostics, Inc. immunology, urinalysis pregnancy test, Strep A, urine reagent strips Innovative Laboratory Solutions, LLC toxicology drug screen Innovita (Tangshan) Biological Technology Co. Ltd. immunology pregnancy test Independent Medical Co-Op, Inc. immunology, toxicology drug screen, pregnancy test Intrinsic Interventions, Inc. toxicology drug screen Jant Pharmacal Corp. immunology, toxicology drug screen, fecal occult, H. pylori, mono, pregnancy test, Strep A, TSH, urine reagent strips Labsystems Diagnostics Oy immunology pregnancy test Lendas, UAB toxicology drug screen LIA Diagnostics, Inc. immunology pregnancy test LifeSign, LLC immunology fecal occult, H. pylori, influenza, mono, pregnancy test, Strep A LumiQuick Diagnostics, Inc. toxicology drug screen MACHEREY-NAGEL GmbH & Co. KG urinalysis urine reagent strips Mandarin Enterprises, LLC immunology pregnancy test Magenta Technology Partners, LLC toxicology drug screen Masena Invest BV immunology pregnancy test McKesson Medical-Surgical immunology, urinalysis drug screen, H. pylori, mono, pregnancy test, Strep A, urine reagent strips Medical Disposables Corporation immunology, toxicology drug screen, fecal occult Medical Distribution Group, Inc. toxicology drug screen Medical Electronic Systems, LLC immunology semen Medimpex United, Inc. immunology, toxicology drug screen, pregnancy test Medline Industries, Inc. immunology, urinalysis drug screen, fecal occult, influenza, mono, pregnancy test, urine reagent strips Mercedes Scientific, Inc. toxicology drug screen Meridian Bioscience, Inc. immunology pregnancy test Mergers Marketing, Inc. immunology, toxicology drug screen, pregnancy test Mesa Biotech, Inc. immunology Strep A MFB Fertility, Inc. immunology fertility test Micro Distributing II, Ltd. toxicology drug screen Mosie, LLC immunology pregnancy test Mossman Associates, Inc. toxicology drug screen MotilityCount ApS immunology semen MP Biomedicals, LLC toxicology drug screen MyDrugTestCups.com, LLC toxicology drug screen Nantong EGENS Bio Technology Company immunology pregnancy test National Diagnostic Products Pty. Ltd. clinical chemistry blood glucose National Distribution & Contracting, Inc. immunology fecal occult, H. pylori, mono, pregnancy test, Strep A National Test Systems, LLC toxicology drug screen Native Diagnostics, Inc. toxicology drug screen Natural Cycles Nordic AB immunology pregnancy test NewScen Coast Bio-Pharmaceutical Co., Ltd. immunology pregnancy test NexScreen, LLC toxicology drug screen Noble Medical, Inc. toxicology drug screen Omega Laboratories, Inc. toxicology drug screen On-Site Testing Specialists, Inc. toxicology drug screen OraSure Technologies, Inc. immunology, toxicology drug screen, HCV, HIV-1 Origin, Inc. toxicology drug screen Owens & Minor, Inc. immunology pregnancy test Phamatech, Inc. toxicology drug screen Pharmaceutical Marketing Systems, Inc. immunology TSH Pinnacle BioLabs, LLC urinalysis urine reagent strips Polymed Therapeutics, Inc. immunology, toxicology drug screen, pregnancy test Polymedco, Inc. immunology BTA, fecal occult, H. pylori, mono, pregnancy test, Strep A Premier Biotech, Inc. toxicology drug screen Prestige Brands Holdings, Inc. immunology pregnancy test Princeton BioMeditech Corporation immunology, toxicology drug screen, fecal occult, H. pylori, ovulation test, pregnancy test, Strep A Proctor and Gamble immunology pregnancy test Professional Medical, Inc. urinalysis urine reagent strips Propper Manufacturing Co., Inc. immunology fecal occult Qingdao Hightop Biotech Co. Ltd. immunology pregnancy test Qualigen, Inc. immunology TSH Quidel Corporation immunology, urinalysis H. pylori, influenza, mono, pregnancy test, RSV, Strep A, urine reagent strips, vaginal pH Rapid Pathogen Screening, Inc. adenovirus, MMP-9 pregnancy test Rapid Self Test, Inc. toxicology drug screen Redwood Toxicology Laboratory, Inc. toxicology drug screen Rhema Scientific, Inc. toxicology drug screen RightBio Metrics, Inc. immunology gastric pH Runbio Biotech Co., Ltd. immunology ovulation test, pregnancy test SA Scientific, Ltd. immunology influenza, pregnancy test, RSV, Strep A Sandstone Diagnostics, Inc. immunology semen Sasmar, Inc. immunology pregnancy test Savyon Diagnostics Ltd. urinalysis urine reagent strips Scanwell Health, Inc. urinalysis urine reagent strips Safecare Biotech (Hangzhou) Co. Ltd. immunology, toxicology drug screen, pregnancy test Scanadu, Inc. urinalysis urine reagent strips SCI Medic, Inc. immunology, toxicology, urinalysis drug screen, pregnancy test, urine reagent strips Screening Devices Canada, Inc. clinical chemistry TSH Sekisui Diagnostics, LLC immunology influenza, mono, pregnancy test, Strep A, trichomonas Serim Research Corporation immunology H. pylori Shanghai Chemtron Biotech Co., Ltd. immunology pregnancy test Shenzhen Bioeasy Biotechnology Co., Ltd. toxicology drug screen Siemens Healthcare GmbH urinalysis urine reagent strips SMC Direct, LLC immunology, urinalysis pregnancy test, Strep A, urine reagent strips SolCraft, Inc. immunology pregnancy test SpermCheck immunology semen Speedy Solutions, LLC toxicology drug screen Stanbio Laboratory L.P. immunology, urinalysis fecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips Sugentech, Inc. immunology pregnancy test Swiss Precision Diagnostics GmbH immunology ovulation test, pregnancy test Syntron Bioresearch, Inc. immunology, toxicology, urinalysis drug screen, pregnancy test, urine reagent strips SZIO+, Inc. urinalysis urine reagent strips Tanner Scientific, Inc. urinalysis urine reagent strips Teco Diagnostics, Inc. immunology, toxicology, urinalysis drug screen, fecal occult, ovulation test, pregnancy test, urine reagent strips Thermo Fisher Scientific, Inc. immunology, urinalysis fecal occult, H. pylori, influenza, pregnancy test, RSV, Strep A, urine reagent strips Tianjin New Bay Bioresearch Co. Ltd. immunology pregnancy test TransMed Co., LLC toxicology drug screen Transmetron, Inc. toxicology drug screen Trinity Biotech Plc immunology H. pylori, HIV-1 True Diagnostics, Inc. immunology pregnancy test Turklab AS immunology pregnancy test UA Cups, Inc. toxicology drug screen UCP Biosciences, Inc. toxicology drug screen Ultimate Analysis Cup, Inc. toxicology drug screen Universal Meditech, Inc. immunology, urinalysis fecal occult, pregnancy test, urine reagent strips Uqora, Inc. urinalysis urine reagent strips US Diagnostics, Inc. toxicology drug screen UTest toxicology drug screen uVera Diagnostics, Inc. toxicology drug screen Verify Diagnostics, Inc. immunology, toxicology drug screen, pregnancy test VicTorch Meditek, Inc. immunology pregnancy test Visby Medical, Inc. immunology STI test W.H.P.M., Inc. immunology, toxicology drug screen, pregnancy test Weihai Kangzhou Biotechnology Engineering Co., Ltd. immunology pregnancy test Wholepower Biotech Co., Ltd. immunology pregnancy test Wiener Laboratorios SAIC urinalysis urine reagent strips WOLFE, Inc. toxicology drug screen Wondfo Biotech Co. Ltd. immunology, toxicology drug screen, ovulation test, pregnancy test Xiamen Useful Import and Export Co., Ltd. toxicology drug screen YD Diagnostics urinalysis urine reagent strips Zer Hitech Ltd. immunology pregnancy test Zhejiang Orient Gene Biotech Co., Ltd. immunology fecal occult, pregnancy test

The following is a list of additional vendors verified to offer CLIA-certified moderate or complex diagnostic instruments and/or test kits. The same methodology was used as above for CLIA-waived, with the exception of opting to not provide specifics about instrument and test types.

Note: Most of these vendors sell analyzers and tests that are CLIA-certified moderate or complex. However, is ultimately up to the potential buyer to verify with the vendor an item's CLIA certification status before purchase.

AB Sciex Pte. Ltd. Abbot Accelerate Diagnostics, Inc. Access Bio, Inc. Acro Biotech, LLC Advin Biotech, Inc. AESKU.GROUP GmbH & Co. KG Aggredyne, Inc. Agilent Technologies, Inc. AiDe Diagnostic Co., Ltd. Akonni Biosystems, Inc. Alba Bioscience Ltd. ALCOR Scientific, Inc. Alfa Wassermann, Inc. Alifax S.r.l. Alpha Laboratories Ltd. American Laboratory Products Company Ltd. Ansh Labs, LLC Applied Biocode, Inc. Applied Spectral Imaging, Inc. Arlington Scientific, Inc. ARK Diagnostics, Inc. Associates of Cape Cod, Inc. Astute Medical, Inc. ATAGO U.S.A., Inc. Athelas, Inc. Atlas Medical Ltd. Avioq, Inc. Awareness Technology, Inc. AXIM Biotechnologies, Inc. Azure Biotech, Inc. BacterioScan, Inc. Beckman Coulter, Inc. Becton, Dickinson and Company - Biosciences Becton, Dickinson and Company - Molecular Baebies, Inc. The Binding Site Group Ltd. binx health, Inc. Bio-Rad Laboratories, Inc. Biocare Medical, LLC Biocartis NV Biofire Diagnostics, LLC BioGenix Laboratories, Inc. Biofortuna Ltd. bioLytical Laboratories, Inc. bioMérieux SA Biorex Labs, LLC BioSystems SA BioTek Instruments, Inc. Bioview Ltd. Boditech Med, Inc. Bonraybio Co., Ltd. BÜHLMANN Laboratories AG BRAHMS GmbH Bruker Corporation Cardinal Health, Inc. Carolina Liquid Chemistries Corp. CellaVision AB CD Diagnostics, Inc. Cepheid Check-Points Health BV Chembio Diagnostic Systems, Inc. Chrono-Log Corporation Clever Culture Systems AG Clinical Diagnostics Solutions, Inc. Curetis NV Denka Company Limited DiAgam SA DIAGAST SAS Diagnostic Grifols SA Diagnostica Stago, Inc. Diamond Diagnostics, Inc. DiaSorin S.p.A. Diatron Medical Instruments Ltd. Diazyme Laboratories, Inc. DIESSE Diagnostica Senese SpA DIRUI Industrial Co. Ltd. Drew Scientific, Inc. Drawbridge Health, Inc. EDAN Instruments, Inc. Eiken Chemical Co., Ltd. ELITech Group SAS Erba Diagnostics Mannheim GmbH Erba Lachema s.r.o. EUROIMMUN Medizinische Labordiagnostika AG Eurospital SpA

First Light Diagnostics, Inc. Focus Diagnostics, Inc. Foundation Medicine, Inc. FUJIFILM Healthcare Americas Corporation Fujirebio Europe NV Genalyte, Inc. GenBio GenMark Diagnostics, Inc. GenPrime, Inc. Genzyme Corporation GlycoMark, Inc. Gold Standard Diagnostics Great Basin Corporation Guangzhou Wondfo Co., Ltd. Guardant Health, Inc. Haemonetics Corporation Hardy Diagnostics, Inc. Healgen Scientific, LLC Healthy.io Ltd. Helena Laboratories Corporation Helix OpCo, LLC HemaTechnologies Hemosonics, LLC Henry Schein, Inc. Hologic, Inc. HORIBA, Ltd. - Main Site HORIBA, Ltd. - MedTestDx) Hycor Biomedical, Inc. HYPHEN Biomed SAS iCubate, Inc. IDS PLC iLine Microsystems SL Illumina, Inc. Immucor, Inc. Immunalysis Corporation Immuno Concepts N.A. Ltd. Immuno-Mycologics, Inc. Immunodiagnostic Systems Holdings PLC Immunotech sro InBios International, Inc. Independent Medical Co-Op, Inc. InDevR, Inc. Infrared Laboratory Systems, LLC Invivoscribe, Inc IVD Research, Inc. iXensor Co., Ltd. Jana Care, Inc. Kamiya Biomedical Company, LLC KPS Analytics KRONUS, Inc. Laborie Medical Technologies Corp. Leica Biosystems Nussloch GmbH LifeSign, LLC Lin-Zhi International, Inc. Liofilchem srl Lite-On Technology Corporation Luminex Corporation LumiQuick Diagnostics, Inc. M Dialysis AB MACHEREY-NAGEL GmbH & Co. KG MagnaBioSciences, LLC Medica Corporation Medical Electronic Systems, LLC Medical Wire & Equipment Medicon Hellas SA Medimpex United, Inc. Medtronic PLC MELET SCHLOESING Laboratoires SA MeMed Diagnostics, Ltd. Meridian Bioscience, Inc. Meso Scale Diagnostics, LLC MetaSystems Indigo GmbH Micro Distributing II, Ltd. Minaris Medical America, Inc. Mindray Medical International Ltd. Mitsubishi Chemical Medience Corp. Monobind, Inc. Myriad Genetics, Inc. Nano-Ditech Corporation NanoEnTek, Inc. NantHealth, Inc. Native Diagnostics International NeuMoDx Molecular, Inc. NexScreen, LLC NG Biotech SAS Nova Biomedical Corporation

NOVX Systems, Inc. NOWDiagnostics, Inc. One Lambda, Inc. OPKO Health, Inc. OPTI Medical Systems OraSure Technologies, Inc. Orion Diagnostica Oy Ortho-Clinical Diagnostics, Inc. Otsuka Pharmaceutical Co., Ltd. Oxford Gene Technology IP Limited Oy Medix Biochemica Ab Pall Corporation Panion & BF Biotech Inc. Parsagen Diagnostics, Inc. PerkinElmer, Inc. Phamatech, Inc. Pixcell Medical Technologies, Ltd. Pointe Scientific, Inc. Polymedco CDP, LLC Polymer Technology Systems, Inc. Precision BioLogic, Inc. Premier Biotech, Inc. Progenika Biopharma SA Psychemedics Corporation QIAGEN GmbH Quidel Corporation Quotient Ltd. R-Biopharm AG r2 Diagnostics Radiometer Medical ApS Randox Laboratories Ltd. Rapid Detect, Inc. Reichert, Inc. Response Biomedical Corporation Roche Diagnostics Sakae, Inc. Sanguina, LLC Scopio Labs Ltd. Sebia SA Sekisui Diagnostics PEI, Inc. Sentinel CH SpA Serosep Ltd. Shenzhen Bioeasy Biotechnology Co. Ltd. Shenzhen New Industries Biomedical Engineering Co. Ltd. Siemens Healthcare Diagnostics Sight Diagnostics Ltd. Skyla Corporation Spectral Medical, Inc. SSI Diagnostica A/S Stanbio Laboratory L.P. Stratec Biomedical AG Streck, Inc. Svar Life Science AB Sysmex America, Inc. T2 Biosystems, Inc. TaiDoc Technology Corporation Tecan Trading AG TECHLAB, Inc. Teco Diagnostics, Inc. TEM Innovations GmbH Texas BioGene, Inc. Thermo Fisher Scientific Tokyo Boeki Holdings Corp. Tosoh Corporation Trinity Biotech Plc Universal Meditech, Inc. URIT Medical Electronic Group Co., Ltd. Vela Diagnostics Pte. Ltd. Viramed Biotech AG Werfen Wiener Laboratorios SAIC Wuxi BioHermes Biomedical Technology Co. Ltd. YD Diagnostics Corp.

3.2.2 Other vendors

As previously mentioned, some vendors manufacturing and distributing medical diagnostic and research solutions don't get their instruments and tests CLIA certified in the U.S. It's beyond the scope of this guide to attempt to list them all, but a few representative examples include:

• Abacus Diagnostica Oy
• Carl Zeiss Meditec AG
• Devyser AB
• Dia.Pro Diagnostic Bioprobes Srl
• Dynamiker Biotechnology (Tianjin) Co., Ltd.
• Dynex Technologies, Inc.
• EntroGen, Inc.
• Eppendorf AG
• Euroclone Diagnostica Srl
• Fast Track Diagnostics Luxembourg Sàrl
• Hitachi High-Technologies Corporation
• HTZ Ltd.
• Humasis Co., Ltd.
• Institut Virion\Serion GmbH
• JEOL USA, Inc.
• Launch Diagnostics Ltd.
• Mettler-Toledo International, Inc.
• MKL Diagnostics AB
• Nikon Corporation
• NovaTec Immundiagnostica GmbH
• Olympus Corporation of the Americas
• ORGENTEC Diagnostika GmbH
• Sartorius AG
• Shimadzu Corporation
• Vircell SL
• Waters Corporation

Also, see BioPharmGuy's worldwide diagnostics companies, by location.

3.3 EHR vendors

An electronic health record (EHR) is an evolving concept, "defined as a longitudinal collection of electronic health information about individual patients and populations." It is a record in digital format that is theoretically capable of being shared across different health care settings. In some cases, this sharing can occur by way of network-connected enterprise-wide information systems and other information networks or exchanges.

In the United States, many EHRs have been certified by the Office of the National Coordinator's (ONC) Health IT Certification Program. Those certifications are based on "standards, implementation specifications and certification criteria adopted by the Secretary." The ONC's Certified Health IT Product List is an excellent resource for browsing EHR and electronic medical record (EMR) vendors. It can be found at https://chpl.healthit.gov/. One approach is to click the "Browse All' button, then on the new screen select "Certification Status" and uncheck "Suspended by ONC" and "Suspended by ONC-ACB." That will give you a list of active results. Of course, you can apply additional filters, compare products (including certification criteria and clinical quality measures), and download results.