DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST

DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST is an FDA 510(k)-cleared medical device (K870155) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 9, 1987. Regulation: 8.