ZEUS IFA(TM) nDNA Test System, ZEUS dIFine

ZEUS IFA(TM) nDNA Test System, ZEUS dIFine is an FDA 510(k)-cleared medical device (K231616) manufactured by Zeus Scientific. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 30, 2023. Regulation: 8.