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FDA Clears Test for Bacteria That Can Cause Serious Intestinal Disease
Date:4/8/2011

breaks of CDI associated with aggressive strains in recent years now have a new testing tool to detect this disease," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics Device Evaluation and Safety in the FDA's Center for Devices and Radiological Health.

People at risk of developing the bacterial infection include the elderly, patients in hospitals or living in a nursing home, and people taking antibiotics for another infection. The most effective way to prevent CDI is thorough hand-washing with soap and warm water.

The Cepheid Xpert C. difficile/Epi test is made by Cepheid of Sunnyvale, Calif.

For more information:

FDA: Medical Devices

http://www.fda.gov/MedicalDevices/default.htm

FDA: Device Approvals and Clearances

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm

CDC: Prevent Clostridium difficile Infection

http://www.cdc.gov/Features/Clostridiumdifficile/

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


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SOURCE U.S. Food and Drug Administration
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