SYPHILIS IGG HUMAN SERUM CONTROLS

SYPHILIS IGG HUMAN SERUM CONTROLS is an FDA 510(k)-cleared medical device (K960493) manufactured by Pyramid Biological Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 16, 1996. Regulation: 8.