QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR

QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR is an FDA 510(k)-cleared medical device (K905049) manufactured by Quidel Corp.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 6, 1991. Regulation: 8.