Glucose monitoring devices (FDA cleared/home use) Medical Devices – Page 39

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 39COMPLEXITY
Major Biosystem Corp. AP-2020 Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Major Biosystem Corp. AP-2020multi Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Major Biosystem Corporation, AP-3000 Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Major Biosystem Corporation, AP-3000multi Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Matrix Distributors, Inc. NexGen Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
McKesson Corporation SunMark Performance Plus Blood Glucose Monitoring System, TrueTrack Smart System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
McKesson SunMark Sidekick Blood Glucose Testing System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
McKesson SunMark Performance Plus Sidekick Blood Glucose Test System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
McKesson Sunmark TrueTrack Smart System, Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
MEDIC BLOOD GLUCOSE SYSTEM
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Medicine Shoppe International TrueTrack Smart System, Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Medicine Shoppe Sidekick Blood Glucose Test System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
MediSense Companion 2 Sensor
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
MediSense ExacTech Blood Glucose Test Strips
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
MediSense ExacTech Companion Blood Glucose Sensor
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
MediSense ExacTech Pen Blood Glucose Sensor
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
MEDISENSE EXACTECH RSG BLOOD GLUCOSE SYSTEM
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
MediSense ExacTech Sensor
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
MediSense MediSense 2 Blood Glucose Testing System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
MEDISENSE OPTIUM EASY BLOOD GLUCOSE TESTING SYSTEM
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED


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