IVD Department for Quantitative Blood Glucose Testing - Vietnam Registration 2403233ĐKLH/BYT-HTTB

Blood Glucose Test: The blood glucose test strip, used in conjunction with a dedicated blood glucose meter, is designed to quantify glucose in the blood of patients with microvascular, venous, arterial blood, and the blood of newborns. It is intended for self-monitoring by patients with diabetes and for use by healthcare professionals to perform point-of-care testing on patients. The dedicated blood glucose meter is the Accu-Chek Active. Patients with diabetes can use blood from the microvascular system, freshly obtained from the tip of a finger, or an alternative blood sampling site. Healthcare professionals can use blood from the venous system, which has been anticoagulated with lithium heparin, ammonium heparin, or EDTA, arterial blood, or blood from newborns. The Accu-Chek Active system is intended for the monitoring of blood glucose in diabetes. The Accu-Chek Active system comprises the Accu-Chek Active meter, the Accu-Chek Active test strip, and the Accu-Chek Active control solution. Control Solution for Quantitative Blood Glucose Testing: This control solution is used to assess the performance of the Accu-Chek Active test strip and the dedicated blood glucose meter. It is intended for self-monitoring by patients with diabetes and for use by healthcare professionals to perform point-of-care testing on patients. The dedicated test strip and device are the Accu-Chek Active test strip and the Accu-Chek Active meter.