Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series is an FDA 510(k)-cleared medical device (K230790) 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 May 18, 2023. Regulation: 8.