VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)

VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) is an FDA 510(k)-cleared medical device (K952095) manufactured by Biomerieux Vitek, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 11, 1996. Regulation: 8.