Axim Biotechnologies Inc (AXIM)

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From Page 55 of 10-Q.
Currently AXIM 510K approved tests are Class II tests. Only sites or Laboratories with CLIA certificates can use the tests. AXIM is seeking a waiver from this CLIA requirement.

Unless exempted by regulation, medical devices may not be commercially distributed in the United States until they have been cleared or approved by the FDA. Medical devices are classified into one of the three classes, Class I, II or III, on the basis of the controls necessary to reasonably assure their safety and effectiveness. Class II devices, which our two test for lactoferrin and IgE are classified are subject to general controls, such as labeling, pre-market notification and adherence to good manufacturing practices. Laboratories or sites that perform our tests need to have a CLIA certificate, be inspected, and must meet the CLIA quality standards.