Difference between revisions of "Template:Vendors of CLIA-waived items"

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   | style="background-color:white; padding-left:10px;"|fecal occult
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  | style="font-weight: bold; padding-left:10px;"|[http://www.hightopqd.com/en/index.aspx Qingdao Hightop Biotech Co. Ltd.]
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  | style="background-color:white; padding-left:10px;"|immunology
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  | style="background-color:white; padding-left:10px;"|pregnancy test
 
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   | style="font-weight: bold; padding-left:10px;"|[https://www.qualigeninc.com/ Qualigen, Inc.]
 
   | style="font-weight: bold; padding-left:10px;"|[https://www.qualigeninc.com/ Qualigen, Inc.]
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   | style="background-color:white; padding-left:10px;"|immunology
 
   | style="background-color:white; padding-left:10px;"|immunology
 
   | style="background-color:white; padding-left:10px;"|influenza, pregnancy test, RSV, Strep A
 
   | style="background-color:white; padding-left:10px;"|influenza, pregnancy test, RSV, Strep A
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  | style="font-weight: bold; padding-left:10px;"|[http://en.safecare.com.cn/ Safecare Biotech (Hangzhou) Co. Ltd.]
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  | style="background-color:white; padding-left:10px;"|drug screen
 
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   | style="font-weight: bold; padding-left:10px;"|[http://sciinternational.com/ SCI International, Inc.]
 
   | style="font-weight: bold; padding-left:10px;"|[http://sciinternational.com/ SCI International, Inc.]

Revision as of 03:44, 16 January 2020

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
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
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
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 hematology 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
Fora Care, Inc. 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 Lab, Inc. clinical chemistry blood glucose monitors
i-SENS. Inc. clinical chemistry blood glucose monitors
Jant Pharmacal Corp. hematology hematology devices
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
Medline Industries, Inc. clinical chemistry, urinalysis blood glucose monitors, urine analyzers
MHC Medical Products, LLC clinical chemistry blood glucose monitors
MiCoBioMed Co., Ltd. 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
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
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
Visgeneer, 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
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
Atlas Medical Ltd. 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
bioLytical Laboratories, Inc. immunology HIV-1
Biomerica, Inc. immunology fecal occult, ovulation test, pregnancy test
bioMérieux SA immunology pregnancy test
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 pregnancy test
Cenogenics Corp. immunology, urinalysis fecal occult, pregnancy test, urine reagent strips
Cepheid immunology influenza, Strep A
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
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
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
First Check Diagnostics, LLC toxicology drug screen
Germaine Laboratories, Inc. immunology, urinalysis fecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips
Halyard Worldwide, Inc. immunology H. pylori
Hangzhou Clongene Biotech Co. Ltd. immunology pregnancy test
Healgen Scientific, LLC immunology, toxicology, urinalysis drug screen, pregnancy test, 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
i-Health, Inc. urinalysis urine reagent strips
Immunostics, Inc. immunology, urinalysis fecal occult, pregnancy test, Strep A, urine reagent strips
Innovita (Tangshan) Biological Technology Co. Ltd. immunology pregnancy test
Independent Medical Co-Op, Inc. immunology, toxicology drug screen, pregnancy test
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
LifeSign, LLC immunology fecal occult, H. pylori, mono, pregnancy test, Strep A
MACHEREY-NAGEL GmbH & Co. KG urinalysis urine reagent strips
Magenta Technology Partners, LLC toxicology drug screen
McKesson Medical-Surgical immunology, urinalysis H. pylori, mono, pregnancy test, Strep A, urine reagent strips
Medimpex United, Inc. immunology, toxicology drug screen, pregnancy test
Medline Industries, Inc. immunology, urinalysis fecal occult, influenza, mono, pregnancy test, urine reagent strips
Meridian Bioscience, Inc. immunology pregnancy test
Micro Distributing II, Ltd. toxicology drug screen
Mossman Associates, Inc. toxicology drug screen
MP Biomedicals, 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
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
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
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
Safecare Biotech (Hangzhou) Co. Ltd. toxicology drug screen
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
Siemens Healthcare GmbH urinalysis urine reagent strips
SMC Direct, LLC immunology, urinalysis pregnancy test, Strep A, urine reagent strips
SpermCheck immunology semen
Stanbio Laboratory L.P. immunology, urinalysis fecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips
Swiss Precision Diagnostics GmbH immunology ovulation test, pregnancy test
Syntron Bioresearch, Inc. immunology, toxicology, urinalysis drug screen, pregnancy test, 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
Transmetron, Inc. toxicology drug screen
Trinity Biotech Plc immunology H. pylori, HIV-1
Turklab AS immunology pregnancy test
UCP Biosciences, Inc. toxicology drug screen
Ultimate Analysis Cup, Inc. toxicology drug screen
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
Wiener Laboratorios SAIC urinalysis urine reagent strips
WOLFE, Inc. toxicology drug screen
Wondfo Biotech Co. Ltd. immunology, toxicology drug screen, ovulation test, pregnancy test
YD Diagnostics urinalysis urine reagent strips
Zer Hitech Ltd. immunology pregnancy test
Zhejiang Orient Gene Biotech Co., Ltd. immunology fecal occult, pregnancy test