Regulation of diagnostic test kits
In general, if a given diagnostic product contains all materials needed to run a particular test, including instructions on interpretation of results, and if the intent of the manufacturer is to provide a self-contained, point-of-care product, such an application may be considered a diagnostic kit, and is under regulation by the United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Center for Veterinary Biologics.
More information is available at the Center for Veterinary Biologics web site.
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