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In accordance with the U.S Food and Drug Administration (FDA) final rule regarding Laboratory Developed Tests (LDTs), the North Carolina State Laboratory of Public Health is implementing this medical device form to collect information regarding medical device performance. As defined, a medical device is an in vitro diagnostic product, in this case an LDT, used, designed, or manufactured in a single, certified CLIA laboratory for clinical use.
Updated: February 3, 2025