IMMUNO-CEPT D (BETA-MONOCLONAL)

IMMUNO-CEPT D (BETA-MONOCLONAL) is an FDA 510(k)-cleared medical device (K863741) manufactured by Immunostics Co., Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 12, 1986. Regulation: 8.