Glucose monitoring devices (FDA cleared/home use) Medical Devices – Page 3

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 3	COMPLEXITY
AFW Alliance Health Care America TrueTrack Smart System, Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AgaMatrix CareOne Premium Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AgaMatrix CareOne Value Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AgaMatrix GRACEpro Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AgaMatrix Inc. AgaMatrix JAZZ Wireless 2 Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Agamatrix Inc., One Drop Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AgaMatrix Jazz Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AgaMatrix KeyNote Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AgaMatrix Liberty Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AgaMatrix Liberty Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AgaMatrix WaveSense AMP Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AgaMatrix WaveSense Jazz Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AgaMatrix WaveSense KeyNote Codeless Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AgaMatrix WaveSense KeyNote Pro Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AgaMatrix WaveSense Presto Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AgaMatrix WaveSense Presto Pro Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AgaMatrix, Inc. CVS Health Advanced Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AgaMatrix, Inc. GoodSense Premium Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AgaMatrix, Inc. Nugget Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
AK Medical, Glucose Shepherd Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED

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