Address:Yousuien-nai,Kamigyo-ku Kyoto,JP
Device Description : Assure Prism Control Solution contains a known amount of glucose that reacts wit Assure Prism Control Solution contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 015482530068 is used as the assigned UDI for the Class I device.)
Device Class : 1
Duns Number: 008171162
Premarket Exempt : Yes
Prescription Use : No
Device Description : Blood Glucose Test Strips
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : Blood Glucose Test Strips, Individually Foiled
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantita The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes.
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : GLUCOCARD Shine Level 1 Control Solution contains a specific amount of glucose t GLUCOCARD Shine Level 1 Control Solution contains a specific amount of glucose that is used to check the performance of the meter and test strips. The test results you obtain should fall within the control solution range printed on the vial of test strips. (Primary UPC# 015482540050 is used as the assigned UDI for the Class I device.)
Device Class : 1
Duns Number: 008171162
Premarket Exempt : Yes
Prescription Use : No
Device Description : GLUCOCARD Shine Level 2 Control Solution contains a specific amount of glucose t GLUCOCARD Shine Level 2 Control Solution contains a specific amount of glucose that is used to check the performance of the meter and test strips. The test results you obtain should fall within the control solution range printed on the vial of test strips. (Primary UPC# 015482540074 is used as the assigned UDI for the Class I device.)
Device Class : 1
Duns Number: 008171162
Premarket Exempt : Yes
Prescription Use : No
Device Description : The GLUCOCARD Shine Test Strips are for use with the GLUCOCARD Shine Blood Gluco The GLUCOCARD Shine Test Strips are for use with the GLUCOCARD Shine Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes.
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : The GLUCOCARD Shine Test Strips are for use with the GLUCOCARD Shine Blood Gluco The GLUCOCARD Shine Test Strips are for use with the GLUCOCARD Shine Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes.
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantita The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes.
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for the quant The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf.
Device Class : 2
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No