Becton Dickinson gains FDA nod for bacteria test:
This article was originally published in Clinica
Executive Summary
Becton Dickinson has gained FDA 510(k) approval to sell its Phoenix automated microbiology system in the US for the identification and susceptibility testing of clinically relevant bacteria. The clearance includes the Phoenix instrument, software and a number of antimicrobial agents for in vitro testing. The system's test panels, which incorporate 45 self-indicating fluorogenic and chromogenic substrates, can be used for a combination of bacteria identification and susceptibility testing, or for either use alone, says the firm.
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