FDA Classifies Device for Detecting Non-Microbial Analytes in Human Infections
May 09, 2025
May 09, 2025
WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has finalized the classification of a new medical device designed to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections.
This classification decision, published in the Federal Register on May 9, 2025, will categorize the device under class II (special controls), ensuring reasonable assurance of safety and ef . . .
This classification decision, published in the Federal Register on May 9, 2025, will categorize the device under class II (special controls), ensuring reasonable assurance of safety and ef . . .