VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192

VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 is an FDA 510(k)-cleared medical device (K001460) manufactured by bioMerieux, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 3, 2000. Regulation: 8.