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The AGE Reader and Diab-spot have received approval in a number of countries. Please check with the distributor in your country or Diagnoptics what the regulatory approval status is in your country. US Caution: Federal law restricts the AGE Reader and Diab-spot system to investigational use only. Commercial distribution has not been granted by the US FDA. Please see the AGE Reader and Diab-spot user manuals for descriptions of all relevant warnings, cautions, contraindications and safety information.