
Abbott Laboratories
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Alinity i Total ß-hCG Reagent Kit, Alinity i System is an FDA 510(k)-cleared medical device (K170317) manufactured by Abbott 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 October 22, 2017. Regulation: 8.