CARDS(TM) STREP A CATALOG NO. CR-7545

CARDS(TM) STREP A CATALOG NO. CR-7545 is an FDA 510(k)-cleared medical device (K863647) manufactured by Pacific Biotech, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 25, 1986. Regulation: 8.