NEW YORK (GenomeWeb) – Accelerate Diagnostics today said that it has received ISO 13485:2003 certification. 

The company received certification for its quality management system and has started manufacturing and installing good manufacturing practice-compliant systems at select sites for a clinical trial in preparation of a submission to the US Food and Drug Administration for clearance of the Accelerate ID/AST System. The company also plans to seek FDA clearance for an associated test for positive blood cultures following the successful completion of the trial. 

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