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Viramed Biotech AG
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VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS is an FDA 510(k)-cleared medical device (K092693) 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 November 24, 2009. Regulation: 8.