LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM

LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM is an FDA 510(k)-cleared medical device (K894252) 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.