Annex II Certification Enables Faster Sales On Modified Products ASHDOD, Israel, Feb. 19, 2016 /PRNewswire/ — Integrity Applications, Inc. (OTCQB: IGAP), maker of GlucoTrack®, a non-invasive device for measuring glucose levels of people with Type 2 diabetes and pre-diabetics, today announced that it has received an extension of its ISO 13485:2003 certificate and Annex II […]
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GlucoTrack® intended use: GlucoTrack® Model DF-F is a non-invasive intermittent glucose monitoring device for home-use. GlucoTrack® model DF-F is intended for adults 18 years and older with type 2 diabetes or pre-diabetes.
Medications intake and/or treatment decisions should not be based solely on GlucoTrack® model DF-F measurements. GlucoTrack® Model DF-F is a glucose monitoring device and should not be used for diagnosis purposes.
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