To date, no HbA1c tests have been cleared by U.S. Food and Drug Administration

Glucose is transported from the intestines or liver to body cells via
the bloodstream, and is made available for cell absorption via the
hormone insulin, produced by the body primarily in the pancreas. The
mean normal blood glucose level in humans is about 4 mM (4 mmol/L or
72 mg/dL, i.e. milligrams/deciliter); however, this level fluctuates
throughout the day. Glucose levels are usually lowest in the morning,
before the first meal of the day (termed "the fasting level"), and
rise after meals for an hour or two by a few millimolar. The normal
blood glucose level (tested while fasting) for non-diabetics, should
be between 70 and 100 milligrams per deciliter (mg/dL). Blood sugar
levels for those without diabetes and who are not fasting should be
below 125 mg/dL. The blood glucose target range for diabetics,
according to the American Diabetes Association, should be 70 - 130
(mg/dL) before meals, and less than 180 mg/dL after meals (as measured
by a bloodglucose monitor). A persistently high level is referred to
as hyperglycemia - When operating normally the body restores blood
sugar levels to a range of 4.4 to 6.1 mmol/L (82 to 110 mg/dL)
Shortly after a meal
the blood glucose level may rise temporarily up to 7.8 mmol/L (140
mg/dL) - HbA1c "A area of push to rapid Test as have shown not
conclusive in discovery of diabetes" To date, no HbA1c tests have been
cleared witha diagnosis claim, but we believe that certain devices may
be able to obtain such a claim with data demonstrating that they are
accurate and reliable enough for this purpose.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Consult your Doctor as in Claim of failure of HbA1c test in Judicial
Jurisdiction a timeline of 10 years of released fully by U.S. Food and
Drug Administration can be cleared of claim.

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