• Regulatory NewsRegulatory News

    FDA Classifies IVDs for Bacillus Detection

    In vitro diagnostic (IVD) devices for the detection of the Bacillus species were assigned to class II on Friday, following the release of a US Food and Drug Administration (FDA) final rule. The IVDs are prescription devices and indicated to aid in the diagnosis of diseases caused by the Bacillus species, including anthrax. They are intended for the detection and differentiation of the bacteria, such as Bacillus anthracis , and had been unclassified devices prior ...
  • Feature ArticlesFeature Articles

    Bacillus Calmette-Guerin--Another Surprise!

    • 19 October 2012
    After a physical several years ago, my wife learned that red and white blood cells were detected in her urine. The doctor ordered an intravenous pyelogram to determine the cause. In this test, an iodine-containing contrast material is injected into the bloodstream and a series of X-rays are then taken at timed intervals. The resulting films allow the radiologist to view the entire urinary tract. Unfortunately, the diagnosis revealed evidence of bladder cancer, a well-di...