VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE

VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE is an FDA 510(k)-cleared medical device (K082329) manufactured by Viramed Biotech AG. 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 4, 2009. Regulation: 8.