DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO

DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO is an FDA 510(k)-cleared medical device (K850574) manufactured by American Dade. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 11, 1985. Regulation: 8.