BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST

BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST is an FDA 510(k)-cleared medical device (K971349) manufactured by Princeton BioMeditech Corp.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 6, 1997. Regulation: 8.