OPTI Blood Gas analysers - An in vitro diagnostic medical device (IVD)- All OPTI CCA-TS2 analyzers (GD7046)- OPTI CCA-TS analyzers (GD7013) with serial numbers 2700 and above - OPTI CCA analyzers (GD7045) with serial numbers 8056 and above- OPTI R analyzers (GD7031) with serial numbers 1334 and aboveARTG Number: 227530