Sigma-Aldrich Corporation has received ISO 13485 certification for expanded quality assurance capabilities at its Dekalb and Barton facilities located in St. Louis, US.
With the certification, the company can manufacture and offer raw materials such as enzymes, proteins and antibodies used in diagnostic assays.
These two St. Louis-based sites join the growing roster of ISO 13485 certified facilities located in Jerusalem and Rehovot (Israel, obtained in Q4 of 2014), which manufacture antibodies and enzymes, as well as the St. Louis Ewing site, which provides original equipment manufacturers assay production services to diagnostic customers.