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

ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II is an FDA 510(k)-cleared medical device (K971522) 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 March 2, 1998. Regulation: 8.