Glucose monitoring devices (FDA cleared/home use) Medical Devices – Page 5

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 5COMPLEXITY
Ames Glucometer ENCORE Blood Glucose Test Strips
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Ames Glucometer ENCORE QA Blood Glucose Meter
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Ames Glucometer ENCORE System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Ames Glucometer GX Blood Glucose Meter
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Ames Glucometer II Blood Glucose Meter
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Ames Glucometer M Blood Glucose Meter
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Ames Glucometer M+ Blood Glucose Meter
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Ames Glucometer QA Blood Glucose Meter
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Ames Glucostix Blood Glucose Reagent Strips
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Andon Health Co., Ltd, iHealth Align Gluco-Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Andon Health Co., LTD. AG-608N Multi Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Andon Health Co., LTD. AG-608N Single Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Andon Health Co., LTD. AG-695 Multi Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Andon Health Co., LTD. AG-695 Single Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Andon Health Co., LTD. AG-696 Multi Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Andon Health Co., LTD. AG-696 Single Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Andon Health Co., LTD. iHealth Wireless Smart Gluco-Monitoring System (BG5)
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Andon Health Co., LTD. iHealth Wireless Smart Gluco-Monitoring System (BG5L)
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Andon Health Co., Ltd., andon AG-605 Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED


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