BIOSTREP A-DIRECT STREP A ANTIGEN TEST

BIOSTREP A-DIRECT STREP A ANTIGEN TEST is an FDA 510(k)-cleared medical device (K983386) 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 November 24, 1998. Regulation: 8.