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Intended use #1 CanadaThe Accu-Chek
® Inform II system is intended for in vitro diagnostic use in the quantitative determination of blood glucose levels in venous, capillary, arterial, and neonatal whole blood samples for monitoring blood glucose.
The system is also intended for quantitative measurement of glucose (sugar) in venous whole blood, arterial whole blood, and neonate arterial and heel stick whole blood samples throughout all hospital and all professional healthcare settings including patients receiving intensive medical intervention/therapy.
This product is for monitoring hypoglycemia in neonates diagnosed with laboratory glucose methods. The system is indicated for use by healthcare professionals. For healthcare professionals, the system is a bedside unit that can help you provide quality patient care by measuring blood glucose and by automating the record keeping associated with blood glucose and glucose control tests.
Intended use #2 USThe Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertip as an aid in monitoring the effectiveness of glucose control.
The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.
The Accu-Chek Inform II 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.
This system should only be used with single-use, auto-disabling lancing devices.
The multiple-patient use Accu-Chek Inform II Blood Glucose Monitoring System will consist of:
- Meter: Accu-Chek Inform II Meter
- Test Strip: Accu-Chek Inform II Test Strip
- Controls: Accu-Chek Inform II Control Solutions
- Linearity: Accu-Chek Linearity Kit
Intended use #3 ROWThe Accu-Chek
® Inform II is intended for in vitro diagnostic use in the quantitative determination of blood glucose levels in venous, capillary, arterial and neonatal whole blood samples for monitoring blood glucose. The Accu-Chek Inform II is intended for near-patient testing.
Not for self-testing",
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