Lyme B. burgdorferi (IgM) MarStripe Test

Lyme B. burgdorferi (IgM) MarStripe Test is an FDA 510(k)-cleared medical device (K172254) manufactured by Trinity Biotech. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 22, 2017. Regulation: 8.