FDA Clearance for Idaho's Anthrax Detection Assay
The FDA has reviewed Idaho Technologys 510(k) application and cleared the Joint Biological Agent Identification and Diagnostic System (JBAIDS) for use as an aid in the laboratory diagnosis of anthrax.
The JBAIDS Anthrax Detection System can detect the gene components of Bacillus anthracis in a variety of environmental sample types, and also clinical blood samples as well as cultured organisms.
The JBAIDS was selected by the US Department of Defense as the platform for use in rapid identification of over ten pathogens associated with bioterrorism and diseases of military interest. The FDA clearance allows testing of blood and laboratory culture samples to aid in the laboratory identification of B. anthracis, with results in less than one hour.
Source : Idaho Technology Inc. [USA]
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Posted on December 12, 2005