ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)

ANTI-NUCLEAR ANTIBODY TEST KIT (ANA) is an FDA 510(k)-cleared medical device (K822681) manufactured by Amico Lab, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 1982. Regulation: 8.