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NEW YORK (360Dx) – The US Food and Drug Administration today issued a final rule classifying in vitro diagnostic devices for the detection of Bacillus bacteria into class II (special controls) and stated that the devices continue to require a premarket notification, or 510(k), clearance.

Bacillus bacteria detection devices provide a preliminary identification of Bacillus anthracis and other Bacillus species to help diagnose cases of anthrax and other diseases caused by Bacillus bacteria.

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