
Princeton Biomedix
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BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST is an FDA 510(k)-cleared medical device (K925183) manufactured by Princeton Biomedix. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 22, 1993. Regulation: 8.