ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL

ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL is an FDA 510(k)-cleared medical device (K974811) manufactured by Boston Biomedica, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 9, 1998. Regulation: 8.