EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT

EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT is an FDA 510(k)-cleared medical device (K962146) manufactured by Excel Scientific, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 6, 1996. Regulation: 8.