Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit

DEN180032 is the FDA 510(k) clearance record for Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit, a class II device, cleared for Cd Diagnostics, Inc. on 2019-05-23 under FDA product code QGN (Lateral Flow Immunochromatography Assay For Host Infection Biomarkers). FDA's definition for product code QGN reads: "A device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections is identified as an in vitro device intended for the detection and qualitative measurement, quantitative...". FDA records list 2 510(k) clearances for Cd Diagnostics, Inc., from 2019-05-23 to 2021-08-11. As of 2026-09-10, FDA records show no recalls naming DEN180032.