Template:Vendors of CLIA-waived items

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