LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3

LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3 is an FDA 510(k)-cleared medical device (K891475) manufactured by Bio-Rad. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 31, 1989. Regulation: 8.