DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT

DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT is an FDA 510(k)-cleared medical device (K810856) manufactured by Bartels Immunodiagnostic Supplies, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 4, 1981. Regulation: 8.