PRIMA SYSTEM - OLD, BARTELS ELISA - NEW

PRIMA SYSTEM - OLD, BARTELS ELISA - NEW is an FDA 510(k)-cleared medical device (K990664) manufactured by Intracel Corp.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 30, 1999. Regulation: 8.