Business · 27/07/2006

FDA Classifies Fecal Calprotectin Immunological Test Systems as Class II Devices

The FDA is classifying fecal calprotectin immunological test systems as Class II devices, which will be subject to special controls, including a guidance document titled 'Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems,' to ensure the safety and effectiveness of these devices.