CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES

CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES is an FDA 510(k)-cleared medical device (K850256) manufactured by Abbott Laboratories. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 7, 1985. Regulation: 8.