| Z-2701-2020 | Class II | Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1. | June 19, 2020 |
| Z-2401-2020 | Class II | Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics. | May 12, 2020 |
| Z-2117-2020 | Class II | ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnos | April 24, 2020 |
| Z-1728-2020 | Class II | ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25. | March 9, 2020 |
| Z-1580-2020 | Class II | LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-0 | January 24, 2020 |
| Z-0574-2020 | Class II | ARCHITECT HAVAB-G Calibrator, REF 6L27-01 | November 7, 2019 |
| Z-0575-2020 | Class II | Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince | October 23, 2019 |
| Z-0544-2020 | Class II | Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution | September 16, 2019 |
| Z-0543-2020 | Class II | Alinity ci Level Sensor, Bulk Solution | September 16, 2019 |
| Z-0545-2020 | Class II | Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution | September 16, 2019 |
| Z-2363-2019 | Class II | Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci ser | June 10, 2019 |
| Z-2201-2019 | Class II | The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. | May 21, 2019 |
| Z-1709-2019 | Class II | Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on | April 15, 2019 |
| Z-1497-2019 | Class II | Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) | April 5, 2019 |
| Z-1316-2019 | Class II | Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following | March 7, 2019 |
| Z-1196-2019 | Class II | Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a | February 26, 2019 |
| Z-1197-2019 | Class II | Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a | February 26, 2019 |
| Z-0789-2019 | Class II | Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Num | December 20, 2018 |
| Z-1629-2018 | Class II | ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA | December 14, 2017 |