BION MUMPS-G ANTIBODY TEST SYSTEM

BION MUMPS-G ANTIBODY TEST SYSTEM is an FDA 510(k)-cleared medical device (K926066) manufactured by Bion Ent., Ltd.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 14, 1993. Regulation: 8.