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: