US-FDA
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The US-FDA (United States of America Food and Drug Administration) has reviewed and cleared the BIOMIC System by 510(k) for marketing and sales in the USA. It has been determined that the BIOMIC System accurately and reproducibly measures zone diameters and determines MICs (minimum inhibitory concentrations) that are substantially equivalent to the MICs determined by the reference CLSI broth dilution method.
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Note: The BIOMIC System is currently the only automated zone reader to successfully complete the US FDA 510(k) review process, permitting it to be marketed and sold in the USA.