BACTIGEN(R) GROUP B STREPTOCOCCUS TEST

BACTIGEN(R) GROUP B STREPTOCOCCUS TEST is an FDA 510(k)-cleared medical device (K885003) manufactured by Armkel, LLC. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 6, 1989. Regulation: 8.