iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)

iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) is an FDA 510(k)-cleared medical device (K221802) manufactured by Mawi Dna Technologies. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 2, 2023. Regulation: 8.