Glucose monitoring devices (FDA cleared/home use) Medical Devices – Page 1

Below is a list of medical devices and their corresponding complexity (CLIA WAIVED, MODERATE, or HIGH) when testing for Glucose monitoring devices (FDA cleared/home use). Note that there may be additional pages of medical devices which test for Glucose monitoring devices (FDA cleared/home use) to choose from located at the bottom of the list.

Medical Device – Page 1COMPLEXITY
3test Blood Glucose Monitoirng System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Abbott Diabetes Care Inc. Optium Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Abbott Diabetes Care Inc. Precision Xceed Pro Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Abbott Diabetes Care Inc., FreeStyle Freedom Lite Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Abbott Diabetes Care Inc., FreeStyle Lite Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Abbott Diabetes Care Inc., FreeStyle Precision Neo H Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Abbott FreeStyle 3 Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Abbott FreeStyle 5 Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Abbott Freestyle Connect Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Abbott Freestyle Feedom Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Abbott FreeStyle Flash Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Abbott FreeStyle Freedom Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Abbott FreeStyle Precision Neo Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Abbott Freestyle precision pro blood glucose and beta-ketone monitoring system
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
ABBOTT LABORATORIES, MEDISENSE OPTIUM ADVANCED DIABETES MANAGEMENT SYSTEM
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
ABBOTT MEDISENSE
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
ABBOTT MEDISENSE
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
ABBOTT MEDISENSE PCX BLOOD GLUCOSE TESTING SYSTEM
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
ABBOTT MEDISENSE PCX PLUS BLOOD GLUCOSE TEST STRIPS
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
ABBOTT MEDISENSE PRECISION /OPTIMUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS WITH TRUE MEASURE TECHNOLOGY
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED


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