WONDFO RAPID STREP A TEST

WONDFO RAPID STREP A TEST is an FDA 510(k)-cleared medical device (K133343) manufactured by Guangzhou Wondfo Biotech Co., Ltd.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 30, 2014. Regulation: 8.