VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT

VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT is an FDA 510(k)-cleared medical device (K051071) 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 10, 2005. Regulation: 8.