QUICKVUE IN-LINE ONE-STEP STREP A TEST

QUICKVUE IN-LINE ONE-STEP STREP A TEST is an FDA 510(k)-cleared medical device (K934484) manufactured by Quidel Corp.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 17, 1994. Regulation: 8.