LII:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers

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4. Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers

Part 2 of this guide's resources chapters steps away from LIMS, LIS, and ELN and looks at more the diagnostic equipment and supplies available to laboratories, as well as some applicable EHR vendors should your clinical laboratory require one. Additionally, service providers able to help you with laboratory workflows, billing, and other aspects of clinical diagnostic and research labs are listed here.


4.1 Medical diagnostics instrumentation and equipment vendors

4.1.1 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)[1], 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 November 2021. 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.

4.1.2 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:

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


4.2 EHR vendors

An electronic health record (EHR) is "defined as a longitudinal collection of electronic health information about individual patients and populations."[2] 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."[3] 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.


4.3 Laboratory business intelligence (BI) and workflow solution vendors

These vendors provide software solutions that provide optimization of and insight into the business processes of a laboratory, from revenue management and client interaction to compliance management and process analysis. Some companies such as Soft Computer and Sunquest provide an entire suite of applications, while others focus on specific aspects of running a medical or research laboratory. For additional insight into selecting a BI solution for the medical laboratory, see Arezou Taheri's 2014 open-access journal article (HTML, PDF) on the subject. While dated, its list of key selection factors still largely remains relevant.


4.4 Laboratory billing service providers

These businesses are known to provide revenue management and improvement services to laboratories. Additionally, a handful of these businesses may also offer their own laboratory billing software solutions in addition to providing billing services.


4.5 Consultants

These consultancies seem to focus primarily on helping others plan, choose, and implement an informatics system for the laboratory, though they may offer other services to laboratories, such as computer system validation (CSV), project management, and workflow development. Entities with logos represent sponsors of LIMSwiki and LIMSforum. (The location represents the entity's headquarters.):

Vendor Headquarters Key services Services page
A Byte of Advice, Inc. Fairfield, IL, U.S. "We provide project management, system development, code modification, support and training";
experience with LabVantage and PerkinElmer products
Services page
A2LA Workplace Training Frederick, MD, U.S. LIMS, quality management systems, regulatory compliance assessments, process and risk management, etc. Services page
ABB Ltd. Zurich, Switzerland Provides an expansive set of services. Services page
Accenture PLC Dublin, Ireland Laboratory informatics, LIMS, LIS, ELN, data analytics, managed services, etc. Services page
AKKA Technologies Group Brussels, Belgium Information technology, engineering, clinical data management, regulatory affairs and compliance, etc. Services page
Astrix, Inc. Red Bank, NJ, U.S. "Astrix’s core competency is to assist organizations in the development and implementation of data
management strategies to enhance the collection, processing, analysis and reporting of scientific data."
Services page
Avellana Learning Oy Vantaa, Finland LIMS, LIS, and ELN implementation; open-source software implementation; software validation; quality control Services page
BC Solutions, LLC Phoenix, AZ, U.S. LIS implementation, interface testing and validation, project management and consulting,
data conversion/migration
Services page
BGASoft, Inc. dba LIMS ABC Fort Lauderdale, FL, U.S. Business analysis, lab process improvement, enterprise and cloud architecture, LIMS implementation, etc. Services page
Bika Lab Systems (Pty) Ltd. Western Cape, South Africa LIMS requirement analysis, design, customization, configuration, and testing; training; project management, etc. Services page
Bottom Line Consulting, LLC Endwell, NY, U.S. Labware products, user requirements specifications, vendor selection, project management Services page
Brevitas Consulting, Inc. Sacramento, CA, U.S. Labware products, LIMS implementation; project management; quality assurance, etc. Services page
C4 Database Management, Inc. Port Orchard, WA, U.S. LIS administration, LIS integrity, data integrity, database installation and migration Services page
Chemtech Servicos de Engenharia e Software Ltda. Rio de Janeiro, Brazil Manufacturing execution systems, SCADA, automation, cyber security, etc. Services page
Clarity Compliance Solutions Limited Chepstow, Wales LIMS, system validation, data integrity, process mapping, vendor selection, etc. Services page
Clarkston Consulting Durham, NC, U.S. LIMS, data integrity, process mapping, vendor selection, quality management, project management etc. Services page
Clevr Newstead, QLD, Australia Laboratory process and technology consultations, custom LIMS development Services page
Clinical Lab Consulting, LLC Dublin, OH, U.S. Provides a wide range of services "to all types of clinical laboratories including governmental, academia,
hospital, reference and physician office laboratories."
Services page
Clinical Laboratory Consultants dba Medical Source Marietta, GA, U.S. "Medical Source offers experience, guidance, and unmatched expertise in the physician office and
independent reference laboratory."
Services page
Cosine Consultants Ltd. Strovolos, Cyprus Software customization, data management system consulting, Fission LIMS, etc. Services page
CSols, Inc. Newark, DE, U.S. Laboratory informatics strategic services, ELN and LIMS implementation, computer system validation, and
laboratory vendor-specific technologies
Services page
Digital Lab Consulting Ltd. London, U.K. LIMS, LIS, and ELN implementation; computer system validation; business case development;
requirements definition; project management; vendor selection; etc.
Services page
e-Science Solutions Ltd Whittington, U.K. Information technology, business case development, requirements definition, vendor selection, etc. Services page
EM2 Solutions, Inc. dba Labtopia Houston, TX, U.S. Laboratory informatics strategic services, LIMS implementation, computer system validation,
quality management systems, training, and staffing
Services page
Fructeam SARL Paris, France eLearning tools, clinical trial management systems, LIMS, ELN, SDMS, SAP Services page
HPFM, Inc. Pacifica, CA, U.S. LIMS selection, implementation, and change management; computer system validation; quality
management systems, etc.
Services page
iConnect Consulting, Inc. San Francisco, CA, U.S. LIMS implementation and validation; computer system validation; HL7 electronic communication, training Services page
IMCOR GmbH Filderstadt, Germany LIMS selection and implementation, computer system validation, business process analysis and optimization Services page
InfoWiz Anyang, Gyeonggi, South Korea LIMS, LES, ELN, SDMS, and quality management system selection and implementation; system integration Services page
Kainos Healthcare Solutions, LLC Richmond, VA, U.S. Laboratory informatics, LIMS, LIS, EHR, EMR, quality control, procurement and implementation,
custom development; they also offer a laboratory quality management solution, eQCo
Services page
Kalleid, Inc. Cambridge, MA, U.S. "We work across the value chain in R&D, clinical and quality areas to deliver support services for software
implementations in highly complex, multi-site organizations."
Services page
Lab Insights, LLC Carlsbad, CA, U.S. Laboratory informatics, computer system validation, vendor assessment, HIPAA audits and training,
quality assurance, process improvement, etc.
Services page
LabMetrics, LLC Ishpeming, MI, U.S. Laboratory informatics, automation, instrumentation, compliance and auditing, quality assurance, etc. Services page
Laboratory Advisory Bureau, LLC McAllen, TX, U.S. Clinical laboratory informatics, LIS, quality assurance, compliance and auditing, workflow management, etc. Services page
Laboratory Systems Consulting Celbridge, Ireland Laboratory and scientific informatics, 21 CFR Part 11, project management, etc. Services page
LIMS4U Bedworth, England Laboratory informatics, LIMS Services page
LIMSCON Vienna, Austria Laboratory informatics, LIMS, ELN, CDMS, document management, training, project management,
computer system validation, etc.
Services page
LUFC LabConsultants Mierlo, The Netherlands Laboratory informatics, LIMS, ELN, CDMS, SDMS, vendor selection, computer system validation,
workflows, project management, lab management, etc.
Services page
Nichols Management Group Ltd. York Harbor, ME, U.S. Clinical laboratory informatics, system assessment, implementation, and integration;
project management; workflow management, etc.
Services page
NNIT A/S Søborg, Denmark Laboratory informatics; system assessment, implementation, and integration;
system validation; project management; workflow management; etc.
Services page
Nous Labautomation Support Mariaheide, Netherlands Laboratory process, automation, and regulation assistance; project management;
LIMS, ELN, CDS, and document management system implementation
Services page
NXG Group, Inc. Chennai, India Laboratory informatics, LIMS, testing and validation, system integration management,
business consulting, etc.
Services page
Orbis Labsystems Ltd. Dublin, Ireland Laboratory informatics, LIMS, quality assurance, system integration management, automation, etc. Services page
OSTHUS GmbH Aachen, Germany Laboratory informatics, LIMS, system integration management, business consulting, etc. Services page
prime4services GmbH Karlsruhe, Germany LIMS, project management, vendor selection, quality management and validation, etc. Services page
RevereIT, LLC Sterling, VA, U.S. LIMS, system integration management, system validation, method development and validation,
data migration, vendor selection, etc.
Services page
Sagit Solutions Ltd. Wan Chai, Hong Kong LIMS, implementation management, cloud management, vendor selection, etc. Services page
Scimcon Limited Newmarket, Suffolk, U.K. Laboratory informatics, LIMS, ELN, CDS, SDMS, instrument management, project management Services page
Semaphore Solutions, Inc. Victoria, B.C., Canada Laboratory informatics, LIMS, BaseSpace Clarity LIMS, workflow development, genomics Services page
Sequence, Inc. Morrisville, NC, U.S. Laboratory informatics, LIMS, ELN, CDS, SDMS, data architecture analysis, data analytics Services page
Shaw Informatics Ltd. Horsham, West Sussex, U.K. Laboratory informatics, LIMS, LES, ELN, process mapping, requirements analysis, project management,
vendor selection, deployment strategy, knowledge management solutions, training
Services page
Silver Lining Informatics, LLC Brooklyn, NY, U.S. Laboratory informatics, LIMS, LES, ELN, Labware products, STARLIMS products, LabVantage products,
workflow development, reporting, project management, training
Services page
Solution4Labs Sp. z o.o. Białystok, Poland Laboratory informatics, LIMS, ELN, custom development, Thermo Scientific products,
Agaram Technologies products, etc.
Services page
Techsol Corporation Princeton, NJ, U.S. LIMS, QMS, MES, regulatory affairs, clinical development, software validation, analytics, etc. Services page
up to data professional services GmbH Wörrstadt, Germany Laboratory informatics, LIMS, custom development, Thermo Scientific products, etc. Services page
Validation Systems, Inc. Palo Alto, CA, U.S. Laboratory informatics, microbiological and chemistry services, quality management systems,
computer system validation, etc.
Services page
Verista Fishers, IN, U.S. Laboratory informatics, LIMS, ELN, CDS, laboratory compliance assessments, computer system validation,
project management, etc.
Services page
wega Informatik AG Basel, Switzerland LIMS, data management systems design and implementation, clinical trial management systems,
and electronic data capture for life and chemical sciences
Services page

References


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Citation information for this chapter

Chapter: 4. Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers

Title: Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research

Edition: 2022 Edition

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: January 2022