Intended use: GenUltimate! test strips with calibration codes 4, 10 and 13 are for use with OneTouch, ultra, ultra2 and ultramini meters. They are used to quantitatively measure glucose in fresh capillary whole blood samples taken from the finger, forearm or palm. Testing is done outside the body (in vitro diagnostic use). They are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control. The system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.