| Z-1235-2026 | Class II | CellMek SPS Sample Preparation System, REF: C44603, with software | December 23, 2025 |
| Z-1026-2026 | Class II | Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, | November 26, 2025 |
| Z-1025-2026 | Class II | Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin | November 26, 2025 |
| Z-1221-2026 | Class II | COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffer | November 10, 2025 |
| Z-0889-2026 | Class II | Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality co | November 7, 2025 |
| Z-0428-2026 | Class II | Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer | October 1, 2025 |
| Z-0429-2026 | Class II | Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer | October 1, 2025 |
| Z-0541-2026 | Class II | DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytomete | September 22, 2025 |
| Z-0216-2026 | Class II | DxI 9000 Access Immunoassay Analyzer, Part Number C11137 | September 19, 2025 |
| Z-0215-2026 | Class II | DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 | September 19, 2025 |
| Z-0441-2026 | Class II | SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 | September 17, 2025 |
| Z-0412-2026 | Class II | CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instr | September 8, 2025 |
| Z-0071-2026 | Class II | SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only. | September 3, 2025 |
| Z-2572-2025 | Class II | UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478 | August 13, 2025 |
| Z-2573-2025 | Class II | UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C3452 | August 13, 2025 |
| Z-2574-2025 | Class II | UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802 | August 13, 2025 |
| Z-2575-2025 | Class II | UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858 | August 13, 2025 |
| Z-0032-2026 | Class II | DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without IS | August 4, 2025 |
| Z-2322-2025 | Class II | Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860 | July 10, 2025 |
| Z-2264-2025 | Class II | UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, | June 26, 2025 |