ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)

ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) is an FDA 510(k)-cleared medical device (K952819) 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 January 25, 1996. Regulation: 8.