QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY

QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY is an FDA 510(k)-cleared medical device (K935554) manufactured by Syntron Bioresearch, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 29, 1995. Regulation: 8.