WELLCOLEX E-COLI OI57 ZC60

WELLCOLEX E-COLI OI57 ZC60 is an FDA 510(k)-cleared medical device (K962028) manufactured by Murex Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 31, 1996. Regulation: 8.