| Atellica IM Total PSA II (tPSAII) (P240021) | Siemens Healthcare Diagnostics, Inc. | 2025-12-03 |
| IsoPSA Assay (P200048) | Cleveland Diagnostics, Inc. | 2025-11-28 |
| Access AFP (on DxI 9000 Analyzer) (P980041/S051) | Beckman Coulter, Inc. | 2025-11-03 |
| IMMULITE 2000 PSA (P930027/S037) | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |
| IMMULITE 2000 Free PSA (P060005/S023) | Siemens Medical Solutions Diagnostics Limited | 2025-10-30 |
| IMMULITE 2000 AFP (P010007/S024) | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |
| IMMULITE 2000 Prostate-Specific Antigen (PSA) (P930027/S036) | Siemens Healthcare Diagnostics, Inc. | 2025-08-14 |
| IMMULITE 2000 Systems Free Prostate-Specific Antigen (Free PSA) (P060005/S022) | Siemens Medical Solutions Diagnostics Limited | 2025-08-14 |
| 4Kscore Test (P190022/S003) | Opko Health, Inc. | 2025-07-25 |
| ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (P930036/S025) | Siemens Healthcare Diagnostics, Inc. | 2025-07-16 |
| ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA) (P950021/S030) | Siemens Healthcare Diagnostics | 2025-07-16 |
| ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA) (P990055/S029) | Siemens Healthcare Diagnostics | 2025-07-16 |
| Access Hybritech p2PSA (P090026/S032) | Beckman Coulter, Inc. | 2025-06-16 |
| ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043) | Roche Diagnostics Corp. | 2025-05-27 |
| ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044) | Roche Diagnostics Corp. | 2025-05-27 |
| Dimension TPSA Flex reagent cartridge (P000021/S047) | Siemens Healthcare Diagnostics | 2025-05-22 |
| Dimension FPSA Flex reagent cartridge (P020027/S042) | Siemens Healthcare Diagnostics | 2025-05-22 |
| Access Hybritech free PSA (P970038/S046) | Beckman Coulter, Inc. | 2025-05-15 |
| IMMULITE 2000 Alpha-Fetoprotein (AFP) (P010007/S023) | Siemens Healthcare Diagnostics, Inc. | 2025-04-11 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| Dimension FPSA Flex reagent cartridge (P020027/S041) | Siemens Healthcare Diagnostics | 2025-02-24 |
| Dimension TPSA Flex reagent cartridge (P000021/S046) | Siemens Healthcare Diagnostics | 2025-02-24 |
| IMMULITE® 2000 Prostate-Specific Antigen (PSA) (P930027/S035) | Siemens Healthcare Diagnostics, Inc. | 2025-02-21 |
| IMMULITE 2000 Prostate-Specific Antigen (PSA) (P930027/S034) | Siemens Healthcare Diagnostics, Inc. | 2025-01-15 |
| Elecsys total PSA Test System (P990056/S042) | Roche Diagnostics Corp. | 2024-10-17 |
| Elecsys free PSA Test System (P000027/S040) | Roche Diagnostics Corp. | 2024-10-17 |
| Elecsys free PSA Assay (P000027/S042) | Roche Diagnostics Corp. | 2024-10-08 |
| Atellica IM Alpha Fetoprotein (AFP) (P930036/S024) | Siemens Healthcare Diagnostics, Inc. | 2024-09-23 |
| Atellica IM Prostate-Specific Antigen (PSA) (P950021/S029) | Siemens Healthcare Diagnostics | 2024-09-23 |
| Atellica IM Complexed PSA (cPSA) (P990055/S028) | Siemens Healthcare Diagnostics | 2024-09-23 |
| Access Hybritech PSA (P850048/S060) | Beckman Coulter, Inc. | 2024-09-04 |
| Elecsys total PSA (P990056/S043) | Roche Diagnostics Corp. | 2024-08-30 |
| Elecsys free PSA (P000027/S041) | Roche Diagnostics Corp. | 2024-08-30 |
| Atelica IM Prostate-Specific Antigen (PSA) (P950021/S026) | Siemens Healthcare Diagnostics | 2024-05-15 |
| ARCHITECT AFP / Alinity i AFP (P120008/S029) | Abbott Laboratories | 2024-03-22 |
| Atellica IM complexed PSA (cPSA) (P990055/S025) | Siemens Healthcare Diagnostics | 2024-02-13 |
| Atellica IM Alpha Fetoprotein (AFP) (P930036/S021) | Siemens Healthcare Diagnostics, Inc. | 2024-02-08 |
| Elecsys free PSA (P000027/S039) | Roche Diagnostics Corp. | 2024-02-08 |
| Elecsys total PSA (P990056/S041) | Roche Diagnostics Corp. | 2024-02-08 |
| Architect AFP and Alinity i AFP (P120008/S028) | Abbott Laboratories | 2024-01-30 |
| The 4Kscore Test (P190022/S002) | Opko Health, Inc. | 2024-01-30 |
| 4Kscore Test (P190022/S001) | Opko Health, Inc. | 2024-01-08 |
| ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA (P950021/S027) | Siemens Healthcare Diagnostics | 2023-12-18 |
| ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA (P990055/S026) | Siemens Healthcare Diagnostics | 2023-12-18 |
| ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA (P930036/S022) | Siemens Healthcare Diagnostics, Inc. | 2023-12-18 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S054) | Abbott Laboratories | 2023-12-14 |
| ARCHITECT AFP / Alinity i AFP (P120008/S027) | Abbott Laboratories | 2023-12-14 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S065) | Abbott Laboratories | 2023-12-14 |
| Alinity i Free PSA Reagent Kit (P980007/S053) | Abbott Laboratories | 2023-11-08 |
| Alinity i Total PSA Reagent Kit (P910007/S064) | Abbott Laboratories | 2023-11-08 |
| Alinity i AFP Reagent Kit (P120008/S026) | Abbott Laboratories | 2023-11-08 |
| ARCHITECT Free PSA, Alinity i Free PSA (P980007/S049) | Abbott Laboratories | 2023-10-11 |
| ARCHITECT Total PSA, Alinity i Total PSA (P910007/S060) | Abbott Laboratories | 2023-10-11 |
| ARCHITECT AFP, Alinity i AFP (P120008/S022) | Abbott Laboratories | 2023-10-11 |
| Elecsys free PSA (P990056/S040) | Roche Diagnostics Corp. | 2023-10-05 |
| Elecsys free PSA (P000027/S038) | Roche Diagnostics Corp. | 2023-10-05 |
| Dimension® TPSA Flex® reagent cartridge (P000021/S045) | Siemens Healthcare Diagnostics | 2023-09-26 |
| Dimension® FPSA Flex® reagent cartridge (P020027/S040) | Siemens Healthcare Diagnostics | 2023-09-26 |
| Alinity i AFP (P120008/S025) | Abbott Laboratories | 2023-09-25 |
| Alinity i Total PSA (P910007/S063) | Abbott Laboratories | 2023-09-25 |
| Alinity i Free PSA (P980007/S052) | Abbott Laboratories | 2023-09-25 |
| IMMULITE® AFP, IMMULITE® 2000 AFP (P010007/S016) | Siemens Healthcare Diagnostics, Inc. | 2023-08-30 |
| IMMULITE® 1000 Free PSA, IMMULITE® 2000 Free PSA (P060005/S015) | Siemens Medical Solutions Diagnostics Limited | 2023-08-30 |
| IMMULITE® PSA, IMMULITE® 2000 PSA, IMMULITE® Third Generation PSA, IMMULITE® 2000 Third Generation PSA (P930027/S027) | Siemens Healthcare Diagnostics, Inc. | 2023-08-30 |
| ARCHITECT AFP / Alinity i AFP (P120008/S024) | Abbott Laboratories | 2023-07-10 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S051) | Abbott Laboratories | 2023-07-10 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S062) | Abbott Laboratories | 2023-07-10 |
| ARCHITECT AFP, Alinity i AFP (P120008/S023) | Abbott Laboratories | 2023-06-22 |
| ARCHITECT Free PSA, Alinity i Free PSA (P980007/S050) | Abbott Laboratories | 2023-06-22 |
| ARCHITECT Total PSA, Alinity i Total PSA (P910007/S061) | Abbott Laboratories | 2023-06-22 |
| Access Hybritech PSA reagent pack (P850048/S059) | Beckman Coulter, Inc. | 2023-05-25 |
| Elecsys total PSA, total PSA CalSet II (P990056/S039) | Roche Diagnostics Corp. | 2023-03-23 |
| Elecsys free PSA, free PSA CalSet (P000027/S037) | Roche Diagnostics Corp. | 2023-03-23 |
| ARCHITECT AFP / Alinity i AFP (P120008/S021) | Abbott Laboratories | 2023-01-30 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S059) | Abbott Laboratories | 2023-01-30 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S048) | Abbott Laboratories | 2023-01-30 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S050) | Beckman Coulter, Inc. | 2022-12-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057) | Beckman Coulter, Inc. | 2022-12-16 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S031) | Beckman Coulter, Inc. | 2022-12-16 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S045) | Beckman Coulter, Inc. | 2022-12-16 |
| IMMULITE® /IMMULITE® 1000 AFP and IMMULITE® 2000 AFP (P010007/S017) | Siemens Healthcare Diagnostics, Inc. | 2022-10-14 |
| IMMULITE® /IMMULITE® 1000 PSA, IMMULITE® 2000 PSA and IMMULITE® /IMMULITE® 1000 Third Generation PSA (P930027/S028) | Siemens Healthcare Diagnostics, Inc. | 2022-10-14 |
| IMMULITE® /IMMULITE® 1000 Free PSA and IMMULITE® 2000 Free PSA (P060005/S016) | Siemens Medical Solutions Diagnostics Limited | 2022-10-14 |
| ARCHITECT AFP / Alinity i AFP (P120008/S020) | Abbott Laboratories | 2022-10-12 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S058) | Abbott Laboratories | 2022-10-12 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S047) | Abbott Laboratories | 2022-10-12 |
| ADVIA Centaur (XP/XPT, CP) AFP; Atellica IM AFP (P930036/S020) | Siemens Healthcare Diagnostics, Inc. | 2022-09-30 |
| NMP22 BladderChek Test (P940035/S017) | Abbott Diagnostics Scarborough, Inc. | 2022-07-12 |
| IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 Third Generation PSA (P930027/S026) | Siemens Healthcare Diagnostics, Inc. | 2022-03-29 |
| Atellica® IM Alpha Fetoprotein (AFP) Assay (P930036/S019) | Siemens Healthcare Diagnostics, Inc. | 2022-03-29 |
| Atellica® IM Prostate-Specific Antigen (PSA) Assay (P950021/S025) | Siemens Healthcare Diagnostics | 2022-03-29 |
| IMMULITE/IMMULITE 1000 AFP, IMMULITE 2000 AFP (P010007/S015) | Siemens Healthcare Diagnostics, Inc. | 2022-03-29 |
| IMMULITE / IMMULITE 1000 Free PSA, IMMULITE 2000 Free PSA (P060005/S014) | Siemens Medical Solutions Diagnostics Limited | 2022-03-29 |
| Atellica® IM Complexed PSA (cPSA) Assay (P990055/S024) | Siemens Healthcare Diagnostics | 2022-03-29 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S058) | Beckman Coulter, Inc. | 2022-03-03 |
| Dimension® TPSA Flex® reagent cartridge (P000021/S044) | Siemens Healthcare Diagnostics | 2021-12-20 |
| Dimension® FPSA Flex® reagent cartridge (P020027/S039) | Siemens Healthcare Diagnostics | 2021-12-20 |
| ARCHITECT AFP / Alinity i AFP (P120008/S019) | Abbott Laboratories | 2021-12-17 |