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The SD A1cCare System is a reflectometry immunoassay used for the quantitative measurement of glycated hemoglobin (%HbA1c) levels in fresh fingerstick capillary blood or venous whole blood samples. This system is intended for clinical laboratory and point-of-care use to monitor long term glycemic control of persons previously diagnosed with diabetes. This test is not for screening or diagnosis of diabetes. The SD A1cCare Spoit Type Test Kit is part of the SD A1cCare System. It includes the test panel that receives the blood sample and is used with the SD A1cCare Analyzer for the quantitative measurement of glycated hemoglobin (HbA1c) levels in fresh fingerstick capillary or venous whole blood samples. The system is intended for clinical laboratory and point-of-care use to monitor long term glycemic control in persons previously diagnosed with diabetes. This test is not for screening or diagnosis of diabetes. The SD HbA1c Control Set (Level 1, Level 2) and SD HbA1c Control Level M are intended for use as quality control materials for the SD A1cCare System.

The SD A1cCare System is a reflectometry immunoassay used for the quantitative measurement of glycated hemoglobin (HbA1c) levels in fresh capillary or venous whole blood samples. It is intended for professional use. The SD HbA1c Control Set is intended for use as quality control materials for the SD A1cCare System. The SD A1cCare System include the analyzer, analyzer check strip, DC power adapter, immunoassay test panels, lot-specific calibration code chips, and control set.

SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used to transmit glucose values to compatible mobile application or PC software through use of radio frequency communication. SD GlucoNavii® Mentor NFC Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor NFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavi® Mentor NFC Multi Blood Glucose Monitoring System is not for use in neonates Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended to transmit glucose values to compatible mobile application or PC software through use of radio frequency communication. SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor NFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

SD GlucoNavii® Mentor NFC and NFC Multi Blood Glucose Monitoring Systems are OTC/ Rx blood glucose monitoring systems. The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is indicated for single-patient use at home (over-the-counter; OTC) and should not be shared, while The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is for multi-patient use in a professional healthcare setting(over-the-counter; OTC and prescription; POC), in order to help monitor the effectiveness of diabetes control. NFC devices contain near field communication (NFC) technology. SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System includes: - SD GlucoNavii® Mentor NFC Blood Glucose Meter - SD GlucoNavii® Mentor NFC Blood Glucose Test Strips - SD Glucose Check Strip - SD Glucose Control Solution - Level M - 3V Battery Type CR2032 - User Instruction Guide - Quick Guide - Test Strip Package Insert - Control Solution Package Insert - Carrying Case - Lancing Device, Lancet SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System includes: - SD GlucoNavii® Mentor NFC Multi Blood Glucose Meter - SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips - SD Glucose Check Strip - SD Glucose Control Solution Level M - 3V Battery Type CR2032 - User Instruction Guide - Quick Guide - Test Strip Package Insert - Control Solution Package Insert - Carrying Case Optional software accessory - GlucoNavii® DMS - GlucoNavii® A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current. The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: normal, pre-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm. The system can also set the pre-meal and post-meal mark. Test results are displayed with mg/dL unit. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.