ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM

ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM is an FDA 510(k)-cleared medical device (K951495) manufactured by Bio-Rad Laboratories, 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 December 19, 1995. Regulation: 8.