BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO

BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO is an FDA 510(k)-cleared medical device (K000287) manufactured by Brahms Diagnostica, LLC. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 16, 2000. Regulation: 8.