Difference between revisions of "LII:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/Additional Resources"

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(List of other diagnostic instrument and test kit vendors: Updated URLs)
(List of CLIA-waived POL instrument and test kit vendors: Turned into template)
Line 39: Line 39:
 
'''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 certified moderate or complex. 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.  
 
'''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 certified moderate or complex. 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 items}}
| STYLE="vertical-align:top;"|
+
{| class="wikitable collapsible sortable" border="1" cellpadding="5" cellspacing="0"
+
|-
+
  ! colspan="3"| Vendors of CLIA-waived Instruments and Devices
+
|-
+
  ! style="color:brown; background-color:#ffffee;"| Original manufacturer
+
  ! style="color:brown; background-color:#ffffee;"| Testing domain(s) covered
+
  ! style="color:brown; background-color:#ffffee;"| Device type(s)
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.abaxis.com/ Abaxis, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|chemistry analyzers
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.diabetescare.abbott/ Abbot Diabetes Care]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.pointofcare.abbott/ Abbot Point of Care]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood analyzers, chemistry analyzers
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.aconlabs.com/ ACON Laboratories, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry, hematology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors, hematology devices, urine analyzers
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://advocatemeters.com/ Advocate Meters, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://agamatrix.com/ AgaMatrix, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.alere.com/ Alere, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry, hematology
+
  | style="background-color:white; padding-left:10px;"|chemistry analyzers, hematology devices, molecular immunoassay analyzer
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.allmedicus.com/ All Medicus Co., Ltd.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.alliance-intl.com.tw/en/ Alliance International Co., Ltd.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.americanscreeningcorp.com/ American Screening Corp.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.jiuan.com/ Andon Health Co., Ltd.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.apexbio.com/ Apex Biotechnology Corp.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.arkrayusa.com/ Arkray USA, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.ascensia.com/ Ascensia Diabetes Care Holdings AG]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.bd.com/ Becton Dickson and Company]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|digital immunoassay analyzer
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.bioland.com.hk/ BioLand Technology Ltd.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.bionimeusa.com/ Bionime Corporation]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.biosyslabs.com/ BioSys Laboratories, Inc.]
+
  | style="background-color:white; padding-left:10px;"|urinalysis
+
  | style="background-color:white; padding-left:10px;"|urine analyzers
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.btm-medical.com/ Biotest Medical Corporation]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.biotrondiagnostics.com/ Biotron Diagnostics, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.btnx.com/ BTNX, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry, urinalysis
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors, urine analyzers
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.microdotcs.com/ Cambridge Sensors Ltd.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://claritydiagnostics.com/ Clarity Diagnostics, LLC]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry, hematology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors, hematology devices, urine analyzers
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.coag-sense.com/ CoaguSense, Inc.]
+
  | style="background-color:white; padding-left:10px;"|hematology
+
  | style="background-color:white; padding-left:10px;"|hematology devices
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.delbioww.com/en/Home/Index DELBio, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.ekfdiagnostics.com/ EKF Diagnostics Holding Plc]
+
  | style="background-color:white; padding-left:10px;"|hematology
+
  | style="background-color:white; padding-left:10px;"|hematology devices
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.empecs.com/ Empecs Medical Co., Ltd.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://entrahealth.com/ Entra Health Systems, Ltd.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://epsbio.en.ec21.com/ EPS Bio Technology Corp.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.fifty50pharmacy.com/ Fifty 50 Medical, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://foracare.com/ Fora Care, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.glbiotech.com.tw/ General Life Biotechnology Co., Ltd.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.germainelabs.com/ Germaine Laboratories, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry, urinalysis
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors, urine analyzers
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.gl-diabetes.com/ GL Diabetes, LLC]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://glucoperfect.com/ Gluco Perfect, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.gcmedis.com/src/sub211.php GreenCross Medis Corp.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.hemocue.us/ HemoCue AB]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry, hematology
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors, hematology devices
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.henryschein.com/us-en/medical/ Henry Schein, Inc.]
+
  | style="background-color:white; padding-left:10px;"|urinalysis
+
  | style="background-color:white; padding-left:10px;"|urine analyzers
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.hmdbio.com/ HMD Biomedical, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.homeaide.us/ Home Aide Diagnostics, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://nurserosie.com/ Hummingbird Medical, Inc.<br />dba Nurse Rosie Products]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://ihealthlabs.com/ iHealth Lab, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://i-sens.com/ i-SENS. Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.jantdx.com/ Jant Pharmacal Corp.]
+
  | style="background-color:white; padding-left:10px;"|hematology
+
  | style="background-color:white; padding-left:10px;"|hematology devices
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.onetouch.com/ LifeScan, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.magellandx.com/ Magellan Diagnostics, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood analyzers
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.majorbio.com.tw/ Major Biosystem Co., Ltd.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://eccatalogue.mckesson.com/publication/index.php McKesson Medical-Surgical]<br />[https://secure.mypss.com/ McKesson Medical-Surgical, PSS site]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry, urinalysis
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors, urine analyzers
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.mec-dx.com/ MEC Dynamics Corp.]
+
  | style="background-color:white; padding-left:10px;"|hematology
+
  | style="background-color:white; padding-left:10px;"|hematology devices
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.medline.com/ Medline Industries, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry, urinalysis
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors, urine analyzers
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://mhcmed.com/ MHC Medical Products, LLC]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.micobiomed.com/ MiCoBioMed Co., Ltd.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.novabiomedical.com/ Nova Biomedical Corp.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.okbiotech.com/ Ok Biotech Co., Ltd.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.omnishealth.com/ Omnis Health, LLC]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.optumrx.com/ OptumRx, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.philosys.com/ Philosys Co., Ltd.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.prodigymeter.com/ Prodigy Diabetes Care, LLC]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://ptsdiagnostics.com/ PTS Diagnostics]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry, hematology
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors, hematology devices
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://usdiagnostics.roche.com/ Roche Diagnostics]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry, hematology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors, hematology devices, urine analyzers
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://sdbiosensor.co.kr/ SD BioSensor, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.ekfusa.com/separation-technology/ Separation Technology, Inc.]
+
  | style="background-color:white; padding-left:10px;"|hematology
+
  | style="background-color:white; padding-left:10px;"|hematology devices
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.siemens-healthineers.com/ Siemens Healthcare GmbH]
+
  | style="background-color:white; padding-left:10px;"|hematology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|hematology devices, urine analyzers
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://simplediagnostics.com/ Simple Diagnostics, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://smcdirectonline.com/ SMC Direct, LLC]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry, urinalysis
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors, urine analyzers
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.specialtymedicalsupply.com/ Specialty Medical Group, LLC]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.ekfusa.com/ Stanbio Laboratory L.P.]
+
  | style="background-color:white; padding-left:10px;"|hematology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|hematology devices, urine analyzers
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.swissprecisiondiagnostics.com/ Swiss Precision Diagnostics GmbH]
+
  | style="background-color:white; padding-left:10px;"|urinalysis
+
  | style="background-color:white; padding-left:10px;"|fertility monitor
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.tearlab.com/ TearLab Corporation]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|chemistry analyzers
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.telcare.com/ Telcare, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.trividiahealth.com/ Trividia Health, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.tysonbio.com/ Tyson Bioresearch, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.usdiagnostics.net/ US Diagnostics, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.visgeneer.com.tw/ Visgeneer, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.zenithdiagnostics.com/ Zenith Diagnostics]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose monitors
+
|-
+
|}
+
|}
+
 
+
{|
+
| STYLE="vertical-align:top;"|
+
{| class="wikitable collapsible sortable" border="1" cellpadding="5" cellspacing="0"
+
|-
+
  ! colspan="3"| Vendors of CLIA-waived Test Kits and Supplies
+
|-
+
  ! style="color:brown; background-color:#ffffee;"| Original manufacturer
+
  ! style="color:brown; background-color:#ffffee;"| Testing domain(s) covered
+
  ! style="color:brown; background-color:#ffffee;"| Test kit type(s)
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.1stepdtx.com/ 1 Step Detect Associates, LLC]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|- 
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.alere.com/en/home.html Abbott (formerly Alere/Inverness/Innovacon)]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen, fecal occult, H. pylori, influenza, mono, pregnancy test, Strep A
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.aconlabs.com/ ACON Laboratories, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|drug screen, H. pylori, mono, ovulation test, pregnancy test, Strep A, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.advinbio.com/ Advin Biotech, Inc.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://hemaprompt.com/ Aerscher Diagnostics, LLC]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|fecal occult, gastric occult
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.qdaide.com/ Ai De Diagnostic Co.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.alfascientific.com/ Alfa Scientific Designs, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|drug screen, fecal occult, H. pylori, ovulation test, pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://abmc.com/ American Bio Medica Corp.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.americanscreeningcorp.com/ American Screening Corp.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://ameritek.org/ Ameritek USA, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|fecal occult, ovulation test, pregnancy test, trichomonas
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.analyticon-diagnostics.com/en/ Analyticon Biotechnologies AG]
+
  | style="background-color:white; padding-left:10px;"|urinalysis
+
  | style="background-color:white; padding-left:10px;"|urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.arlingtonscientific.com/ Arlington Scientific, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.artronlab.com/ Artron Laboratories, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://atlas-medical.com/ Atlas Medical Ltd.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.beckmancoulter.com/ Beckman Coulter, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|fecal occult, gastric occult, H. pylori, mono, pregnancy test, Strep A
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.bd.com/en-us Becton Dickson and Company]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|H. pylori, ovulation test, pregnancy test, Strep A
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://bhatbiotech.com/ Bhat Bio-tech India Private Limited]
+
  | style="background-color:white; padding-left:10px;"|urinalysis
+
  | style="background-color:white; padding-left:10px;"|urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://biolytical.com/ bioLytical Laboratories, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|HIV-1
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.biomerica.com/ Biomerica, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|fecal occult, ovulation test, pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.biomerieux-diagnostics.com/ bioMérieux SA]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.biotechscreening.com/ Biotech Screening, LLC]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.biotrondiagnostics.com/ Biotron Diagnostics, Inc.]
+
  | style="background-color:white; padding-left:10px;"|urinalysis
+
  | style="background-color:white; padding-left:10px;"|urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.brananmedical.com/ Branan Medical Corporation]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.btnx.com/ BTNX, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen, fecal occult, FSH, H. pylori, pregnancy test, RSV, Strep A, TSH
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://ecamco.com/ Cambridge Diagnostic Products, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|fecal occult
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.careproductsonline.com/ CARE Products, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|fecal occult
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.cenmedonline.com/ Cen-Med Enterprises, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.cenogenics.net/ Cenogenics Corp.]
+
  | style="background-color:white; padding-left:10px;"|immunology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|fecal occult, pregnancy test, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://chematics.com/ Chematics, Inc.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://chembio.com/ Chembio Diagnostic Systems, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|HIV-1, HIV-2
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.uschemtronbio.com/ Chemtron Biotech, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://churchdwight.com/ Church & Dwight Co., Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://claritydiagnostics.com/ Clarity Diagnostics, LLC]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen, fecal occult, H. pylori, mono
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.cliawaived.com/ CLIAwaived, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|drug screen, fecal occult, H. pylori, pregnancy test, Strep A, TSH, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.clinicalgenomics.com/ Clinical Genomics Technologies Pty. Ltd.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|fecal occult
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.coastlinems.com/ Coastline Medical Management, LLC]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.co-innovation.com.cn/ Co-innovation Biotech Co., Ltd.]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.cs-commonsense.com/ Common Sense Ltd.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|vaginal pH
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.confirmbiosciences.com/ Confirm Biosciences]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.devonmedicalinc.com Devon Medical Products, Inc.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.dficare.com/en/index.php/ DFI Co., Ltd.]
+
  | style="background-color:white; padding-left:10px;"|urinalysis
+
  | style="background-color:white; padding-left:10px;"|urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.diagnosticsdirect2u.com/ Diagnostics Direct, LLC]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|syphilis
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://healthcare-manager.com/ EASY at Home Medical, LLC]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://eklacorp.com/ EKLA Corporation]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.drugcheck.com/ Express Diagnostics International, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.firstcheckfamily.com/ First Check Diagnostics, LLC]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.germainelabs.com/ Germaine Laboratories, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|fecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://products.halyardhealth.com/ Halyard Worldwide, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|H. pylori
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.healgen.com/ Healgen Scientific, LLC]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.helena.com/ Helena Laboratories Corp.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|fecal occult
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.henryschein.com/us-en/medical/ Henry Schein, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|fecal occult, H. pylori, influenza, mono, pregnancy test, Strep A, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.heritagehouse76.com/ Heritage House '76 Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://homehealth-uk.com/ Home Health UK, Ltd.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.azoproducts.com/ i-Health, Inc.]
+
  | style="background-color:white; padding-left:10px;"|urinalysis
+
  | style="background-color:white; padding-left:10px;"|urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.immunostics.com/ Immunostics, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|fecal occult, pregnancy test, Strep A, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.imcoinc.com/ Independent Medical Co-Op, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.jantdx.com/ Jant Pharmacal Corp.]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen, fecal occult, H. pylori, mono, pregnancy test, Strep A, TSH, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.kasaaclaboratories.com/ Kaasac Laboratories]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://labsystemsdx.com/ Labsystems Diagnostics Oy]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.lifesignmed.com/ LifeSign, LLC]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|fecal occult, H. pylori, mono, pregnancy test, Strep A
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.mn-net.com/ MACHEREY-NAGEL GmbH & Co. KG]
+
  | style="background-color:white; padding-left:10px;"|urinalysis
+
  | style="background-color:white; padding-left:10px;"|urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://eccatalogue.mckesson.com/publication/index.php McKesson Medical-Surgical]
+
  | style="background-color:white; padding-left:10px;"|immunology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|H. pylori, mono, pregnancy test, Strep A, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.meditests.com/ Medimpex United, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.medline.com/ Medline Industries, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|fecal occult, influenza, mono, pregnancy test, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.meridianbioscience.com/ Meridian Bioscience, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.micro-distributing.com/ Micro Distributing II, Ltd.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.mossmanassociates.com/ Mossman Associates, Inc.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.mpbio.com/ MP Biomedicals, LLC]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.egens-bio.com/ Nantong EGENS Bio Technology Company]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://betachek-europe.com/ National Diagnostic Products Pty. Ltd.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|blood glucose test strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.proadvantagebyndc.com/ National Distribution & Contracting, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|fecal occult, H. pylori, mono, pregnancy test, Strep A
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.ntsbiz.com/ National Test Systems, LLC]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://nativediagnostics.com/ Native Diagnostics, Inc.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://en.newscen.com/ NewScen Coast Bio-Pharmaceutical Co., Ltd.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.nexscreen.com/ NexScreen, LLC]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.noblemedical.com/ Noble Medical, Inc.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.ostsus.com/ On-Site Testing Specialists, Inc.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.oraquick.com/ OraSure Technologies, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen, HCV, HIV-1
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.owens-minor.com/ Owens & Minor, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.phamatech.com/ Phamatech, Inc.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.tshchek.com/ Pharmaceutical Marketing Systems, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|TSH
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.pblabs.com/ Pinnacle BioLabs, LLC]
+
  | style="background-color:white; padding-left:10px;"|urinalysis
+
  | style="background-color:white; padding-left:10px;"|urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.polymedt.com/ Polymed Therapeutics, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.polymedco.com/ Polymedco, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|BTA, fecal occult, H. pylori, mono, pregnancy test, Strep A
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.premierintegrity.com/ Premier Integrity Solutions, Inc.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.eptfamily.com/ Prestige Brands Holdings, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.pbmc.com/ Princeton BioMeditech Corporation]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen, fecal occult, H. pylori, ovulation test, pregnancy test, Strep A
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://us.pg.com/ Proctor and Gamble]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.proppermfg.com/ Propper Manufacturing Co., Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|fecal occult
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.qualigeninc.com/ Qualigen, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|TSH
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.quidel.com/ Quidel Corporation]
+
  | style="background-color:white; padding-left:10px;"|immunology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|H. pylori, influenza, mono, pregnancy test, RSV, Strep A, urine reagent strips, vaginal pH
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://ramcolab.com/ Ramco Laboratories, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.rpsdetectors.com/ Rapid Pathogen Screening, Inc.]
+
  | style="background-color:white; padding-left:10px;"|adenovirus, MMP-9
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.redwoodtoxicology.com/ Redwood Toxicology Laboratory, Inc.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://rightbiometrics.com/ RightBio Metrics, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|gastric pH
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.runbio-bio.com/ Runbio Biotech Co., Ltd.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|ovulation test, pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.sascientific.com/ SA Scientific, Ltd.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|influenza, pregnancy test, RSV, Strep A
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://sciinternational.com/ SCI International, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://thyrochek.com/ Screening Devices Canada, Inc.]
+
  | style="background-color:white; padding-left:10px;"|clinical chemistry
+
  | style="background-color:white; padding-left:10px;"|TSH
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.sekisuidiagnostics.com/ Sekisui Diagnostics, LLC]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|mono, pregnancy test, Strep A, trichomonas
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.serim.com/ Serim Research Corporation]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|H. pylori
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.chemtronbio.com/ Shanghai Chemtron Biotech Co., Ltd.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.siemens-healthineers.com/ Siemens Healthcare GmbH]
+
  | style="background-color:white; padding-left:10px;"|urinalysis
+
  | style="background-color:white; padding-left:10px;"|urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://smcdirectonline.com/ SMC Direct, LLC]
+
  | style="background-color:white; padding-left:10px;"|immunology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|pregnancy test, Strep A, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://spermcheck.com/ SpermCheck]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|semen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.ekfusa.com/ Stanbio Laboratory L.P.]
+
  | style="background-color:white; padding-left:10px;"|immunology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|fecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.swissprecisiondiagnostics.com/ Swiss Precision Diagnostics GmbH]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|ovulation test, pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.syntron.net/ Syntron Bioresearch, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://tannerscientific.com/ Tanner Scientific, Inc.]
+
  | style="background-color:white; padding-left:10px;"|urinalysis
+
  | style="background-color:white; padding-left:10px;"|urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.tecodiagnostics.com/ Teco Diagnostics, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|drug screen, fecal occult, ovulation test, pregnancy test, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.fishersci.com/ Thermo Fisher Scientific, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, urinalysis
+
  | style="background-color:white; padding-left:10px;"|fecal occult, H. pylori, influenza, pregnancy test, RSV, Strep A, urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.transmetrondrugtest.com/ Transmetron, Inc.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.trinitybiotech.com/ Trinity Biotech Plc]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|H. pylori, HIV-1
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.turklab.com.tr Turklab AS]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://ucpbiosciences.com/ UCP Biosciences, Inc.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.uacups.com/ Ultimate Analysis Cup, Inc.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.usdiagnostics.net/ US Diagnostics, Inc.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://uveradiagnostics.com/ uVera Diagnostics, Inc.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.victorch.com/ VicTorch Meditek, Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.whpm.com/ W.H.P.M., Inc.]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://www.wiener-lab.com.ar/EN/ Wiener Laboratorios SAIC]
+
  | style="background-color:white; padding-left:10px;"|urinalysis
+
  | style="background-color:white; padding-left:10px;"|urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[https://wolfeinc.com/ WOLFE, Inc.]
+
  | style="background-color:white; padding-left:10px;"|toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://wondfousa.com/ Wondfo Biotech Co. Ltd.]
+
  | style="background-color:white; padding-left:10px;"|immunology, toxicology
+
  | style="background-color:white; padding-left:10px;"|drug screen, ovulation test, pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.yd-diagnostics.com/ YD Diagnostics]
+
  | style="background-color:white; padding-left:10px;"|urinalysis
+
  | style="background-color:white; padding-left:10px;"|urine reagent strips
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.zerhitech.com/ Zer Hitech Ltd.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|pregnancy test
+
|-
+
  | style="font-weight: bold; padding-left:10px;"|[http://www.orientgene.com/ Zhejiang Orient Gene Biotech Co., Ltd.]
+
  | style="background-color:white; padding-left:10px;"|immunology
+
  | style="background-color:white; padding-left:10px;"|fecal occult, pregnancy test
+
|-
+
|}
+
|}
+
  
 
===List of other diagnostic instrument and test kit vendors===
 
===List of other diagnostic instrument and test kit vendors===

Revision as of 00:35, 16 January 2020

Setting up and running a physician office laboratory (POL) requires resources and know-how. The more you know the better, they say. This chapter offers a variety of additional resources for those who want to know more about setting up and operating a POL, including vendors, distributors, consultants, and other recommended reading. Note: The appearance of an entity on these lists does not constitute as an endorsement for that entity.

This seventh chapter containing additional resources has eight sections.

-----Return to the beginning of this guide-----

6. Additional Resources

Addendum

The following LIMSwiki pages are addendum to the rest of the material presented here.

Further reading

Clinical laboratories, including the POL

Point-of-care testing

Other

List of CLIA-waived POL instrument and test kit vendors

The following is a list of vendors verified to sell CLIA-waived instruments and/or test kits. Vendors were pulled from the FDA's downloadable CLIA file from May 2015. 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 certified moderate or complex. 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 blood analyzers, chemistry analyzers
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
Alere, Inc. clinical chemistry, hematology chemistry analyzers, hematology devices, molecular immunoassay analyzer
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
Applied Biomedical, LLC clinical chemistry blood glucose monitors
Arkray USA, Inc. clinical chemistry blood glucose monitors
Ascensia Diabetes Care Holdings AG clinical chemistry blood glucose monitors
Becton Dickson and Company immunology digital immunoassay analyzer
Bigfoot Biomedical, Inc. clinical chemistry blood glucose monitors
BioLand Technology Ltd. clinical chemistry blood glucose monitors
Bionime Corporation clinical chemistry blood glucose monitors
BioSys Laboratories, Inc. urinalysis urine analyzers
Biotest Medical Corporation clinical chemistry blood glucose monitors
Biotron Diagnostics, Inc. clinical chemistry blood glucose monitors
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
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
Entra Health Systems, 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 Electric Company clinical chemistry blood glucose monitors
General Life Biotechnology Co., Ltd. clinical chemistry blood glucose monitors
Germaine Laboratories, Inc. clinical chemistry, urinalysis blood glucose monitors, urine analyzers
GL Diabetes, LLC clinical chemistry blood glucose monitors
Gluco Perfect, Inc. 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
iHealth Labs, Inc. clinical chemistry blood glucose monitors
i-SENS. Inc. clinical chemistry blood glucose monitors
ijDream Corporation clinical chemistry blood glucose monitors
Infopia Co., Ltd. clinical chemistry blood glucose monitors
Intuity Medical, Inc. clinical chemistry blood glucose monitors
Jant Pharmacal Corp. hematology hematology devices
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
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
MEC Dynamics Corp. hematology hematology devices
MediVena, LLC clinical chemistry blood glucose monitors
Medline Industries, Inc. clinical chemistry, urinalysis blood glucose monitors, urine analyzers
Mesa Biotech, Inc. immunology digital immunoassay analyzer
MHC Medical Products, LLC clinical chemistry blood glucose monitors
MiCoBioMed Co., Ltd. clinical chemistry blood glucose monitors
Midwest Trading Group, Inc. clinical chemistry blood glucose monitors
Nova Biomedical Corp. clinical chemistry blood glucose 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
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
Specialty Medical Group, LLC clinical chemistry blood glucose monitors
Stanbio Laboratory L.P. hematology, urinalysis hematology devices, urine analyzers
Swiss Precision Diagnostics GmbH urinalysis fertility monitor
TearLab Corporation clinical chemistry chemistry analyzers
Telcare, Inc. 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
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
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
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
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
Branan Medical Corporation toxicology drug screen
BTNX, Inc. immunology, toxicology drug screen, fecal occult, FSH, H. pylori, pregnancy test, RSV, Strep A, TSH
Cambridge Diagnostic Products, Inc. immunology fecal occult
CARE Products, Inc. immunology fecal occult
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
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 Strep A
Devon Medical Products, Inc. toxicology drug screen
DFI Co., Ltd. urinalysis urine reagent strips
Diagnostics Direct, LLC immunology syphilis
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
Germaine Laboratories, Inc. immunology, urinalysis fecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips
Get Stix, LLC immunology pregnancy test
Guangzhou Wondfo Co., Ltd. toxicology drug screen
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
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
Innovus Pharmaceuticals, Inc. urinalysis urine reagent strips
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
Kaasac Laboratories toxicology drug screen
Labsystems Diagnostics Oy immunology pregnancy test
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 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 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
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 test strips
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
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
Premier Integrity Solutions, 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
Ramco Laboratories, Inc. immunology pregnancy test
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
Savyon Diagnostics Ltd. urinalysis urine reagent strips
Scanwell Health, Inc. urinalysis urine reagent strips
Safecare Biotech (Hangzhou) Co. Ltd. toxicology drug screen
Scanadu, Inc. urinalysis urine reagent strips
SCI International, Inc. immunology, toxicology, urinalysis drug screen, pregnancy test, urine reagent strips
Screening Devices Canada, Inc. clinical chemistry TSH
Sekisui Diagnostics, LLC immunology mono, pregnancy test, Strep A, trichomonas
Serim Research Corporation immunology H. pylori
Shanghai Chemtron Biotech Co., Ltd. immunology pregnancy test
Shenzhen Aukeyhi Technology 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
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
US Diagnostics, Inc. toxicology drug screen
uVera Diagnostics, Inc. toxicology drug screen
VicTorch Meditek, Inc. immunology pregnancy 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

List of other diagnostic instrument and test kit vendors

The following is a list of additional vendors verified to offer CLIA-certified moderate or complex diagnostic instruments and/or test kits.

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.

Access Bio, Inc.
Acro Biotech, LLC
Advanced Tear Diagnostics, LLC
Aggredyne, Inc.
AiDe Diagnostic Co., Ltd.
Akers Biosciences, Inc.
Alfa Wassermann, Inc.
Alifax S.r.l.
Alpha Laboratories Ltd.
AMS Srl
Astute Medical, Inc.
ATAGO U.S.A., Inc.
Becton, Dickinson and Company
Biofire Diagnostics, LLC
Biokit SA
Biophor Diagnostics, Inc.
Bio-Rad Laboratories, Inc.
Bioview Ltd.
Boditech Med, Inc.
Carolina Liquid Chemistries Corp.
Cepheid
Chrono-Log Corporation
Clinical Diagnostics Solutions, Inc.
Clinical Innovations, LLC
Coramed Technologies, LLC
Diagnostica Stago, Inc.
Diamedix, Inc.
Diamond Diagnostics, Inc.
DiaSorin S.p.A.
Diatron Medical Instruments Ltd.
Diazyme Laboratories
DIRUI Industrial Co., Ltd.
Drew Scientific, Inc.
ELITech Group SAS

Erba Diagonstics Mannheim GmbH
Erba Lachema s.r.o.
Euro Diagnostica AB
Focus Diagnostics, Inc.
GenBio
GenPrime, Inc.
Genzyme Corporation
Gold Standard Diagnostics
Great Basin Corporation
Haemonetics Corporation
Healgen Scientific, LLC
HemaTechnologies
Hitachi Chemical Diagnostics, Inc.
Hologic, Inc.
HORIBA, Ltd.
Hycor Biomedical, Inc.
HYPHEN Biomed SAS
IDS PLC
Immucor, Inc.
Immunalysis Corporation
Immuno-Mycologics, Inc.
InBios International, Inc.
Instrumentation Laboratory
LifeSign, LLC
Luminex Corporation
LumiQuick Diagnostics, Inc.
M Dialysis AB
MACHEREY-NAGEL GmbH & Co. KG
MagnaBioSciences, LLC
Medica Corporation
Medical Electronic Systems, LLC
Medical Wire & Equipment
Medimpex United, Inc.
Medtronic PLC

MELET SCHLOESING Laboratoires SA
Micro Distributing II, Ltd.
Mindray Medical International Ltd.
Mitsubishi Chemical Medience Corp.
Nano-Ditech Corporation
NanoEnTek, Inc.
Native Diagnostics International
NOVX Systems, Inc.
NOWDiagnostics, Inc.
OPTI Medical Systems
Ortho-Clinical Diagnostics, Inc.
Otsuka Pharmaceutical Co., Ltd.
Oy Medix Biochemica Ab
Pall Corporation
PointCare Technologies, Inc.
Premier Biotech, Inc.
Quidel Corporation
r2 Diagnostics
Radiometer Medical ApS
Randox Laboratories Ltd.
Rapid Detect, Inc.
Response Biomedical Corporation
Sakae, Inc.
Spectral Medical, Inc.
Sysmex America, Inc.
T2 Biosystems, Inc.
TECHLAB, Inc.
TEM Innovations GmbH
Tokyo Boeki Machinery Ltd.
Tosoh Corporation
URIT Medical Electronic Group Co., Ltd.
Vital Diagnostics, Inc.
Wako Diagnostics

List of distributors

Distributors of clinical analyzers, point-of-care equipment, and other medical/laboratory supplies and equipment
Distributor Clinical analyzers? Point-of-care? Medical/laboratory
supplies and equipment?
Adelsys, Inc. Y N Y
AKW Medical, Inc. N N Y
Alaska Scientific, Inc. Y Y Y
Andwin Scientific Y Y Y
Atlantic Medical Solutions Y Y Y
Beach Medical Y N N
Block Scientific, Inc. Y Y Y
Cardinal Health, Inc. Y Y Y
Cen-Med Enterprises N Y Y
Clarkson Laboratory and Supply, Inc. Y Y Y
ClearChem Diagnostics Y N Y
Cole-Parmer Instrument Company, LLC N N Y
Concordance Healthcare Solutions, LLC Y Y Y
Daigger Scientific, Inc. N N Y
DRE Medical, Inc. N N Y
Dynamic Diagnostics, Inc. N N Y
ExpotechUSA, Inc. N Y Y
FDI Medical, Inc. Y Y Y
Fisher Healthcare Y Y Y
Fox Scientific, Inc. U U Y
GENEQ, Inc. N N Y
Hamilton Bell Company, Inc. N N Y
Henry Schein, Inc. Y Y Y
High Technology, Inc. Y Y Y
Hoskin Scientific, Ltd. N N Y
Inter Medico Y N Y
Lab Supply Specialists Y Y Y
McGuff Company, Inc. N Y Y
McKesson Medical-Surgical Y Y Y
McMaster-Carr Supply N N Y
Med Lab Supply N Y Y
Medicus Health N N Y
Medline Industries, Inc. N Y Y
Mercedes Scientific Y Y Y
Preiser Scientific N N Y
R. Weinstein Pharmaceuticals & Medical Products Y Y Y
Scientific Supply & Equipment, Inc. Y Y Y
Siemens Healthcare GmbH Y Y N
TechNeal, Inc. Y Y Y
Thomas Scientific N N Y
Troy Biologicals, Inc. N Y Y
Universal Medical N N Y
US Specialty Labs Y N N
USABluebook N N Y
Vessel Medical Y Y N
VWR International Y Y Y
W.W. Grainger, Inc. N N Y

List of consultants in the POL market

The following consultancies state they assist the POL market on their website:

Vendor Headquarters Key services Services page
AMS Medical Laboratories St. Louis, MO, U.S. Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement,
profitability analysis, procedure development, etc.
Services page
Ancillary Medical Solutions San Diego, CA, U.S. Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement,
staffing, procedure development, etc.
Services page
BP Laboratory Consulting, LLC Arvada, CO, U.S. Laboratory start-up, workflow improvement, procedure development, training, regulatory compliance, etc. Services page
C&C Clinical Laboratory Consulting, LLC Dallas, TX, U.S. Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement,
quality management, procedure development, etc.
Services page
Carlos M. Madan & Associates Dallas, TX, U.S. Laboratory start-up, workflow improvement, quality management, procedure development, training,
profitability analysis, etc.
Services page
Catalyst Consulting Austin, TX, U.S. Laboratory start-up, regulatory compliance, workflow improvement, profitability analysis Services page
Clinical Lab Consulting, LLC Carmel, IN, 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
CT POL Consultants South Windsor, CT, U.S. Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement,
LIS, EHR, lab billing, procedure development, etc.
Services page
DoctorsManagement Knoxville, TN, U.S. Laboratory and physician practice accounting, compliance, development, and operation improvement Services page
ELITech Group SAS Puteaux, France Laboratory operations, billing and reimbursement, regulatory assistance, profitability analysis Services page
Gnosis International, LLC Garden Grove, CA, U.S. Laboratory start-up, laboratory operations, regulatory assistance Services page
Harrison Consultant Cleveland, TX, U.S. Pre-inspection evaluation, quality management, regulatory compliance,
procedure development, technical writing, etc.
Services page
K&K Consultant Group, Inc. Torrence, CA, U.S. Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement,
training, procedure development, etc.
Services page
Lab Advisory Bureau Abilene, TX, U.S. Data management, quality managementm, regulatory guidance, training, accreditation prep Services page
Lab IQ, LLC Calabasas, CA, U.S. Compliance management, workflow improvement, training, procedure development, feasibility studies, etc. Services page
LisWalter Consulting New York, NY, U.S. Laboratory informatics, compliance management, quality management, procedure development, training, etc. Services page
Medical Lab Consulting Oklahoma City, OK, U.S. Application processing, staffing, training, workflow management, inspection preparation Services page
Narayan Laboratory Consulting Services, Inc. Philadelphia, PA, U.S. Laboratory start-up, regulatory requirements, training, process development, pre- and post-inspection
guidance, quality management, inspection readiness
Services page
NueMedical Consulting Lawrenceville, GA, U.S. Moderate to complex toxicology laboratory setup and organization Services page
OnTarget Consulting Services, LLC Atlanta, GA, U.S. Accreditation prep, operational and risk assessment, training, process management Services page
Physicians Office Consulting, LLC Jackson, TN, U.S. Laboratory CLIA compliance, regulatory review, and inspection services; laboratory start-up and development Services page
Physicians Office Laboratory Specialists, Inc. Puyallup, WA, U.S. Urine drug testing, opioid addiction treatment Services page
POC Consultants, LLC FL and NJ, U.S. Regulatory compliance, review, and inspection services; training Services page

List of consumables and supplies used in POL

Diagnostic analyzers and devices (CLIA-waived)

  • blood analyzers
  • blood glucose monitors
  • chemistry analyzers
  • digital immunoassay analyzer
  • fertility monitor
  • hematology devices
  • molecular immunoassay analyzer
  • urine analyzers

Diagnostic test kits and supplies (CLIA-waived)

  • blood glucose test strips
  • adenoviral conjunctivitis
  • bladder tumor associated antigen (BTA)
  • drug screen
  • fecal occult blood
  • follicle-stimulating hormone (FSH)
  • gastrick pH
  • gastric occult blood
  • hCG pregnancy test
  • Hepatitis C virus antibody (HCV)
  • HDL cholestrol
  • HIV-1 and/or HIV-2
  • H. pylori
  • influenza A and/or B
  • MMP-9 protein (for dry eye disease)
  • mononucleosis
  • ovulation test
  • respiratory syncytial virus (RSV)
  • semen (fertility)
  • Strep A
  • syphilis
  • trichomonas
  • thyroid-stimulating hormone (TSH)
  • urine reagent strips
  • vaginal pH

Laboratory furniture and equipment

  • balances
  • blood pressure meters
  • cabinets and stands
  • carts
  • centrifuges
  • chairs: doctor and patient
  • EKG machines
  • eyewash stations
  • fume hoods
  • glove boxes
  • hot plates
  • incubators
  • lighting
  • mats and trays
  • microscopes and accessories
  • mills
  • mixers
  • otoscopes
  • refrigerators and freezers
  • scales
  • sharps containers
  • stethoscopes
  • sterilization equipment
  • tables
  • thermometers
  • tube rockers
  • waste containers

Medical supplies

  • bandages and dressings
  • buffers, reagents, and solvents
  • catheters
  • cleaning supplies
  • eyeware and safety goggles
  • face and splash shields
  • gloves: chloroprene, latex, synthetic, vinyl
  • gowns
  • labels and tapes
  • masks
  • needles, lancets, and other sharps
  • ointments
  • pipettes
  • swabs and applicators
  • surgical instruments
  • table paper
  • timers
  • tourniquets
  • tube racks
  • urine and stool containers
  • vacutainer tubes
  • wipes
  • wound cleaners

Laboratory billing and revenue enhancement

The following businesses offer laboratory/medical billing and reimbursement assistance:

References


Citation information for this chapter

Chapter: 6. Additional resources

Title: The Comprehensive Guide to Physician Office Laboratory Setup and Operation

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: June 2015