GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST

GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST is an FDA 510(k)-cleared medical device (K924715) manufactured by Gen-Probe, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 10, 1994. Regulation: 8.