IMMUNODOT TORCH TEST RUBELLA

IMMUNODOT TORCH TEST RUBELLA is an FDA 510(k)-cleared medical device (K884898) manufactured by General Biometrics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 2, 1989. Regulation: 8.