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Zdrowie i gospodarka · 27/08/2015

FDA Classifies Clostridium difficile Toxin Gene Amplification Assay into Class II (Special Controls)

The FDA has classified the Clostridium difficile toxin gene amplification assay into class II (special controls) to ensure the device provides a reasonable assurance of safety and effectiveness.

Source: Federal Register — Food and Drug AdministrationOpen original release →