| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S046) | Abbott Laboratories | 2021-12-15 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S057) | Abbott Laboratories | 2021-12-15 |
| 4Kscore Test (P190022) | Opko Health, Inc. | 2021-12-07 |
| ARCHITECT Free PSA (LN 6C07) (P980007/S045) | Abbott Laboratories | 2021-12-06 |
| ARCHITECT AFP (LN 3P36) (P120008/S018) | Abbott Laboratories | 2021-12-06 |
| ARCHITECT Total PSA (LN 6C06) (P910007/S056) | Abbott Laboratories | 2021-12-06 |
| Elecsys free PSA Test System (P000027/S036) | Roche Diagnostics Corp. | 2021-11-16 |
| Elecsys total PSA Test System (P990056/S038) | Roche Diagnostics Corp. | 2021-11-16 |
| Atellica® IM Alpha Fetoprotein (AFP) Assay (P930036/S018) | Siemens Healthcare Diagnostics, Inc. | 2021-11-09 |
| Dimension Vista FPSA Flex reagent cartridge (P020027/S037) | Siemens Healthcare Diagnostics | 2021-10-08 |
| Dimension Vista TPSA Flex reagent cartridge (P000021/S042) | Siemens Healthcare Diagnostics | 2021-10-08 |
| Atellica® IM Alpha Fetoprotein (AFP) Assay (P930036/S017) | Siemens Healthcare Diagnostics, Inc. | 2021-08-25 |
| AutoDELFIA hAFP Test System (P970037/S012) | Revvity, Inc. | 2021-08-11 |
| Alere NMP22 BladderChek Test (P940035/S016) | Abbott Diagnostics Scarborough, Inc. | 2021-06-15 |
| IMMULITE/IMMULITE 1000 THIRD GENERATION PSA (P930027/S025) | Siemens Healthcare Diagnostics, Inc. | 2021-04-28 |
| IMMULITE/IMMULITE 1000 AFP (P010007/S014) | Siemens Healthcare Diagnostics, Inc. | 2021-04-28 |
| IMMULITE / IMMULITE 1000 FREE PSA (P060005/S013) | Siemens Medical Solutions Diagnostics Limited | 2021-04-28 |
| Atellica IM Alpha Fetoprotein (AFP) Assay (P930036/S016) | Siemens Healthcare Diagnostics, Inc. | 2021-04-27 |
| Atellica IM Complexed PSA (cPSA) Assay (P990055/S023) | Siemens Healthcare Diagnostics | 2021-04-27 |
| Atellica IM Prostate-Specific Antigen (PSA) Assay (P950021/S024) | Siemens Healthcare Diagnostics | 2021-04-27 |
| ARCHITECT Free PSA Reagent Kit, Alinity i Free PSA Reagent Kit (P980007/S044) | Abbott Laboratories | 2021-04-22 |
| ARCHITECT Total PSA Reagent Kit, Alinity i Total PSA Reagent Kit (P910007/S055) | Abbott Laboratories | 2021-04-22 |
| ARCHITECT AFP Reagents, Alinity i AFP Reagent Kit (P120008/S017) | Abbott Laboratories | 2021-04-22 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S030) | Beckman Coulter, Inc. | 2020-12-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S056) | Beckman Coulter, Inc. | 2020-12-16 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S049) | Beckman Coulter, Inc. | 2020-12-16 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S044) | Beckman Coulter, Inc. | 2020-12-16 |
| ARCHITECT Free PSA and Alinity i Free PSA (P980007/S043) | Abbott Laboratories | 2020-11-05 |
| ARCHITECT AFP and Alinity i AFP (P120008/S016) | Abbott Laboratories | 2020-11-05 |
| ARCHITECT Total PSA and Alinity i Total PSA (P910007/S054) | Abbott Laboratories | 2020-11-05 |
| ADVIA Centaur PSA Readypack Reagents (P950021/S023) | Siemens Healthcare Diagnostics | 2020-10-27 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S029) | Beckman Coulter, Inc. | 2020-10-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S055) | Beckman Coulter, Inc. | 2020-10-16 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S043) | Beckman Coulter, Inc. | 2020-10-16 |
| Access AFP Reagents on the Access Immunoassay System (P980041/S048) | Beckman Coulter, Inc. | 2020-10-16 |
| Dimension Vista TPSA Flex reagent cartridge (P000021/S043) | Siemens Healthcare Diagnostics | 2020-10-13 |
| Dimension Vista FPSA Flex reagent cartridge (P020027/S038) | Siemens Healthcare Diagnostics | 2020-10-13 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S028) | Beckman Coulter, Inc. | 2020-10-07 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S042) | Beckman Coulter, Inc. | 2020-10-07 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S047) | Beckman Coulter, Inc. | 2020-10-07 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S054) | Beckman Coulter, Inc. | 2020-10-07 |
| IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 3rd gen PSA (P930027/S024) | Siemens Healthcare Diagnostics, Inc. | 2020-09-08 |
| IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 AFP (P010007/S013) | Siemens Healthcare Diagnostics, Inc. | 2020-09-08 |
| IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 fPSA (P060005/S012) | Siemens Medical Solutions Diagnostics Limited | 2020-09-08 |
| ADVIA Centaur AFP Readypack Reagents (P930036/S015) | Siemens Healthcare Diagnostics, Inc. | 2020-08-25 |
| ADVIA Centaur cPSA Readypack Reagents (P990055/S022) | Siemens Healthcare Diagnostics | 2020-08-25 |
| ADVIA Centaur PSA Readypack Reagents (P950021/S022) | Siemens Healthcare Diagnostics | 2020-08-25 |
| IMMULITE/IMMULITE 1000/IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 Third Generation PSA (P930027/S023) | Siemens Healthcare Diagnostics, Inc. | 2020-08-18 |
| IMMULITE/IMMULITE 1000/IMMULITE 2000 AFP (P010007/S012) | Siemens Healthcare Diagnostics, Inc. | 2020-08-18 |
| IMMULITE/IMMULITE 1000/IMMULITE 2000 Free PSA (P060005/S011) | Siemens Medical Solutions Diagnostics Limited | 2020-08-18 |
| Alinity i Total PSA Assay (P910007/S051) | Abbott Laboratories | 2020-08-07 |
| Advia Centaur PSA Immunoassay and Atellica IM PSA Immunoassay (P950021/S019) | Siemens Healthcare Diagnostics | 2020-07-02 |
| Advia Centaur AFP Immunoassay and Atellica IM AFP Immunoassay (P930036/S012) | Siemens Healthcare Diagnostics, Inc. | 2020-07-02 |
| Adiva Centaur Complexed PSA (cPSA) Immunoassay and Atellica IM cPSA Immunoassay (P990055/S019) | Siemens Healthcare Diagnostics | 2020-07-02 |
| Alinity i Free PSA assay (P980007/S041) | Abbott Laboratories | 2020-06-05 |
| Alinity i AFP Reagent Kit (P120008/S013) | Abbott Laboratories | 2020-06-05 |
| Acess AFP Reagents on the Access Immunoassay Systems (P980041/S043) | Beckman Coulter, Inc. | 2020-05-28 |
| ARCHITECT Free PSA (P980007/S042) | Abbott Laboratories | 2020-05-23 |
| ARCHITECT Total PSA (P910007/S053) | Abbott Laboratories | 2020-05-23 |
| ARCHITECT AFP (P120008/S015) | Abbott Laboratories | 2020-05-23 |
| Alinity i AFP (P120008/S014) | Abbott Laboratories | 2020-05-23 |
| Elecsys total PSA (P990056/S037) | Roche Diagnostics Corp. | 2020-05-12 |
| Elecsys free PSA Test System, Biotin remediation (P000027/S035) | Roche Diagnostics Corp. | 2020-05-12 |
| ARCHITECT Total PSA Reagent/Calibrator/Control Kit (P910007/S052) | Abbott Laboratories | 2020-04-10 |
| Atellica IM Alpha Fetoprotien (AFP) Assay (P930036/S014) | Siemens Healthcare Diagnostics, Inc. | 2020-04-03 |
| Atellica IM Prostate-Specific Antigen (PSA) Assay (P950021/S021) | Siemens Healthcare Diagnostics | 2020-04-03 |
| Atellica IM Complexed PSA (cPSA) Assay (P990055/S021) | Siemens Healthcare Diagnostics | 2020-04-03 |
| ADVIA Centaur and Atellica IM PSA (P950021/S020) | Siemens Healthcare Diagnostics | 2020-03-19 |
| ADVIA Centaur and Atellica IM AFP (P930036/S013) | Siemens Healthcare Diagnostics, Inc. | 2020-03-19 |
| ADVIA Centaur and Atellica IM cPSA (P990055/S020) | Siemens Healthcare Diagnostics | 2020-03-19 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S053) | Beckman Coulter, Inc. | 2020-03-17 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S046) | Beckman Coulter, Inc. | 2020-03-17 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S041) | Beckman Coulter, Inc. | 2020-03-17 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S027) | Beckman Coulter, Inc. | 2020-03-17 |
| IMMULITE 2000 PSA (P930027/S022) | Siemens Healthcare Diagnostics, Inc. | 2019-12-19 |
| IMMULITE 2000 AFP (P010007/S011) | Siemens Healthcare Diagnostics, Inc. | 2019-12-19 |
| IMMULITE 2000 Free PSA (P060005/S010) | Siemens Medical Solutions Diagnostics Limited | 2019-12-19 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S052) | Beckman Coulter, Inc. | 2019-08-09 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S026) | Beckman Coulter, Inc. | 2019-08-09 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S045) | Beckman Coulter, Inc. | 2019-08-09 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S040) | Beckman Coulter, Inc. | 2019-08-09 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S044) | Beckman Coulter, Inc. | 2019-07-31 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S051) | Beckman Coulter, Inc. | 2019-07-31 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S025) | Beckman Coulter, Inc. | 2019-07-31 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S039) | Beckman Coulter, Inc. | 2019-07-31 |
| ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA (P950021/S018) | Siemens Healthcare Diagnostics | 2019-07-25 |
| IMMULITE Systems PSA, IMMULITE 2000 Systems PSA & IMMULITE Systems Third Generation PSA (P930027/S021) | Siemens Healthcare Diagnostics, Inc. | 2019-07-11 |
| Dimension Vista TPSA Flex reagent cartridge (K6452) (P020027/S036) | Siemens Healthcare Diagnostics | 2019-06-26 |
| Dimension Vista TPSA Flex reagent cartridge (K6451) (P000021/S041) | Siemens Healthcare Diagnostics | 2019-06-26 |
| Alinity i AFP Assay (P120008/S011) | Abbott Laboratories | 2019-06-25 |
| Dimension FPSA Flex reagent cartridge (P020027/S035) | Siemens Healthcare Diagnostics | 2019-06-20 |
| Dimension TPSA Flex reagent cartridge (P000021/S040) | Siemens Healthcare Diagnostics | 2019-06-20 |
| AIA-PACK PSA (P910065/S009) | Tosoh Bioscience, Inc. | 2019-06-18 |
| Elecsys total PSA Test System (P990056/S036) | Roche Diagnostics Corp. | 2019-05-03 |
| Elecsys free PSA Test System (P000027/S034) | Roche Diagnostics Corp. | 2019-05-03 |
| Elecsys total PSA (P990056/S035) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys free PSA (P000027/S033) | Roche Diagnostics Corp. | 2019-04-24 |
| Atellica IM Prostate-Specific Antigen (PSA) Assay (P950021/S017) | Siemens Healthcare Diagnostics | 2019-03-08 |
| Atellica IM Alpha Fetoprotein (AFP) Assay (P930036/S011) | Siemens Healthcare Diagnostics, Inc. | 2019-03-08 |
| Atellica IM Complexed PSA (cPSA) Assay (P990055/S018) | Siemens Healthcare Diagnostics | 2019-03-08 |