BILIRUBIN ASSAY KIT DIRECT

BILIRUBIN ASSAY KIT DIRECT is an FDA 510(k)-cleared medical device (K843027) manufactured by Diagnostic Chemicals, Ltd. (Usa). This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 1984. Regulation: 8.