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Accelerate Diagnostics Inc (AXDX.O)

AXDX.O on Consolidated Issue listed on NASDAQ Capital Market

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2 Dec 2016
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Latest Key Developments (Source: Significant Developments)

Accelerate diagnostics submits De Novo request to FDA for phenosystem and phenotest BC kit
Monday, 11 Jul 2016 05:00am EDT 

Accelerate Diagnostics : Accelerate diagnostics submits de novo request to fda for accelerate pheno(tm) system and accelerate phenotest(tm) bc kit .Submitted de novo request for evaluation of automatic class iii designation to u.s. Fda for pheno system and phenotest bc kit.  Full Article

Accelerate Diagnostics Inc announces proposed public offering of common stock
Tuesday, 8 Dec 2015 04:01pm EST 

Accelerate Diagnostics Inc:Has commenced an underwritten public offering of $80 million of shares of its common stock.  Full Article

Accelerate Diagnostics Inc achieves ISO 13485 certification and initial installations of accelerate ID/AST system
Monday, 16 Mar 2015 02:15pm EDT 

Accelerate Diagnostics Inc:Receives ISO 13485:2003 certification for its quality management system and began manufacturing and installing GMP compliant systems at select study sites.Says it will seek FDA clearance of Accelerate ID/AST System and associated test for positive blood cultures upon successful completion of an upcoming clinical trial.  Full Article