| Z-1748-2025 | Class II | Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time rev | April 28, 2025 |
| Z-1749-2025 | Class II | Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (R | April 28, 2025 |
| Z-1665-2025 | Class II | The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers inclu | March 20, 2025 |
| Z-0234-2025 | Class II | Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) RE | September 12, 2024 |
| Z-0233-2025 | Class II | Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) R | September 12, 2024 |
| Z-1602-2024 | Class II | Alinity m System, Part Number: 08N53-002 | March 20, 2024 |
| Z-1188-2024 | Class III | In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbo | February 1, 2024 |
| Z-1189-2024 | Class III | In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; | February 1, 2024 |
| Z-1190-2024 | Class III | Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare | February 1, 2024 |
| Z-0407-2024 | Class II | Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay i | October 30, 2023 |
| Z-1009-2023 | Class II | Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testi | December 9, 2022 |
| Z-0740-2023 | Class II | Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090 | November 22, 2022 |
| Z-0739-2023 | Class II | Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096 | November 22, 2022 |
| Z-1349-2023 | Class II | Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4. | November 11, 2022 |
| Z-0268-2023 | Class II | Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use | October 12, 2022 |
| Z-1679-2022 | Class II | Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1. | August 19, 2022 |
| Z-1518-2022 | Class II | The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use. | July 19, 2022 |
| Z-0883-2022 | Class II | Alinity m HBV Application Specification File (US and CE) | March 4, 2022 |
| Z-0884-2022 | Class II | Alinity m HBV AMP Kit (US and CE) | March 4, 2022 |
| Z-0710-2022 | Class II | Alinity m Integrated Reaction Units (IRU) | February 11, 2022 |