Glucose monitoring devices (FDA cleared/home use) Medical Devices – Page 33

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 33COMPLEXITY
i-SENS, Inc. CareSens N Pop Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
i-SENS, Inc. CareSens N Voice Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
i-SENS, Inc. CareSens N Voice Multi Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
i-SENS, Inc. CareSens POP Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
i-SENS, Inc. NoCoding1 Plus Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
i-Sense Inc. CareSens Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
IDEAL LIFE Gluco-Manager GMM 0001 Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
IDEAL LIFE GlucoManager Blood Glucose Monitoring System, Model GMM0002
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
iHealth BG5 Wireless Smart Gluco-Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
iHealth BG5L Wireless Smart Gluco-Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
iHealth Labs, Inc., AG-607 Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
iHealth Labs, Inc., AG-607 Multi Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
iHealth, SmartGluco – Monitoring System (BG3)
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Infopia America, LLC Element Compact Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Infopia America, LLC Element Compact V Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Infopia America, LLC Element Compact V Multi Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Infopia Co., Ltd. GLucoLab Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Infopia Co., Ltd. GLucoLab Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Infopia Co., Ltd. GluNEO Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Infopia Co., Ltd. GluNEO Lite Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED


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