iDart Lyme IgG ImmunoBlot Kit

iDart Lyme IgG ImmunoBlot Kit is an FDA 510(k)-cleared medical device (K233367) manufactured by Id-Fish Technology, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 11, 2024. Regulation: 8.