SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY

SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY is an FDA 510(k)-cleared medical device (K852665) manufactured by Syncor Intl. Corp.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 12, 1985. Regulation: 8.