BioPlex 2200 25-OH Vitamin D Kit

BioPlex 2200 25-OH Vitamin D Kit is an FDA 510(k)-cleared medical device (K180577) manufactured by Bio-Rad Laboratories. 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 June 21, 2018. Regulation: 8.