QUICKVUE ONE-STEP H. PYLORI II TEST

QUICKVUE ONE-STEP H. PYLORI II TEST is an FDA 510(k)-cleared medical device (K991747) 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 August 3, 1999. Regulation: 8.