AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET

AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET is an FDA 510(k)-cleared medical device (K853081) manufactured by Advanced Medical Technology, Inc.. This device is classified under the Hematology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 12, 1985. Regulation: 8.