Glucose monitoring devices (FDA cleared/home use) Medical Devices – Page 32

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 32COMPLEXITY
Hummingbird Medical Rosie SmartMeter NFC Professional Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Hummingbird Medical, Inc., Oracle Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Hygieia, Inc. BaseSens I Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
HYPOGUARD ADVANCE INTUITION BLOOD GLUCOSE MONITORING SYSTEM
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Hypoguard Advance Micro-Draw Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
HYPOGUARD ASSURE BLOOD GLUCOSE SYSTEM
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Hypoguard Assure II Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Hypoguard Assure Pro Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
HYPOGUARD GLUCOBALANCE DATA MANAGEMENT SOFTWARE
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
HYPOGUARD QUICKTEK BLOOD GLUCOSE METER
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
i-Sens Inc. CareSense Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
i-Sens Inc. DirecTest Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
i-SENS USA, Inc., Auto-Chek Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
I-Sens, Inc. ACURA PLUS Multi Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
i-SENS, Inc. CareSens II Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
i-SENS, Inc. CareSens N Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
i-SENS, Inc. CareSens N LINK Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
i-SENS, Inc. CareSens N LINK Multi Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
i-SENS, Inc. CareSens N Mini Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED


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