As part of the agreement Osiris detailed in its affirmed that Grafix, indicated as a wound cover for the treatment of acute and chronic wounds, is regulated solely as a human cells, tissues, and cellular and tissue-based product under section 361 of the Public Health Service Act .
http://www.hispanicbusiness.com/2013/10/24/osiris_corrects_certain_inaccuracies_in_media.htm
http://www.hispanicbusiness.com/2013/10/24/osiris_corrects_certain_inaccuracies_in_media.htm
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