Glucose monitoring devices (FDA cleared/home use) Medical Devices – Page 38

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 38COMPLEXITY
LifesScan OneTouch UltrasSmart Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
LifesScan OneTouch UltrasSmart Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Lightstar Enterprises, Inc. GlucoTest Excel Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Links Medical Products Inc. microdot Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Longs Drugs Glucose Monitor TrueTrack Smart System, Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Longs Drugs Truetrack Smart System, Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
LXN GO System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
LXN IN CHARGE Diabetes Control System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
LXN BLOOD GLUCOSE TESTING SYSTEM
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
LXN DUET GLUCOSE CONTROL MONITORING SYSTEM
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Major Biosystem Corp. AP-1000 Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Major Biosystem Corp. AP-1000multi Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Major Biosystem Corp. AP-1010 Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Major Biosystem Corp. AP-1010multi Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Major Biosystem Corp. AP-1020 Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Major Biosystem Corp. AP-1020multi Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Major Biosystem Corp. AP-2000 Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Major Biosystem Corp. AP-2000multi Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Major Biosystem Corp. AP-2010 Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Major Biosystem Corp. AP-2010multi Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED


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