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In the August 27, 2015, Federal Register, FDA announced it has classified the Clostridium difficile (C. difficile) toxin gene amplification assay into Class II (special controls) medical device.
United StatesFood, Drugs, Healthcare, Life Sciences
In the August 27, 2015, Federal
Register, FDA announced it has classified the
Clostridium difficile (C. difficile) toxin gene
amplification assay into Class II (special controls) medical
device. Labeling and performance studies are required to mitigate
identified risks.
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