Glucose monitoring devices (FDA cleared/home use) Medical Devices – Page 42

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.

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Medical Device – Page 42	COMPLEXITY
Nova Biomedical Nova One Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Nova Biomedical, Nova Max Link Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Ok Biotech Co., Ltd. Ok Meter Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
OK Biotech Co., Ltd. OKmeter Direct Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
OK Biotech Co., Ltd. OKmeter Match Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Omnis Health Embrace EVO Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Omnis Health Embrace No Code Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Omnis Health Embrace Pro Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Omnis Health Victory Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
OMNIS Health Voice Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
On Call Express Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
On Call Vivid Pal Blood Glucose Monitoring System (ACON Laboratories) Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
OPTUMRx Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Philosys Gmate Origin Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Philosys Gmate SMART Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Philosys Gmate VOICE Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Philosys Inc..Gmate mini Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Philosys Inc..Gmate Step Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Physicians Medical Supply Quick Chek Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Physicians Medical Supply Quick Chek ultra Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED

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