| Atellica IM Alpha Fetoprotein (AFP) (P930036/S010) | Siemens Healthcare Diagnostics, Inc. | 2019-03-07 |
| Sangia Total PSA Test (P170037) | Opko Diagnostics, LLC | 2019-01-30 |
| Access Hybritech p2PSA Reagent Pack (P090026/S023) | Beckman Coulter, Inc. | 2019-01-09 |
| Dimension Vista FPSA Flex reagent cartridge (P020027/S034) | Siemens Healthcare Diagnostics | 2018-12-27 |
| IMMULITE/IMMULITE 1000 PSA and IMMULITE 2000 PSA AND 1000 Third Generation PSA (P930027/S020) | Siemens Healthcare Diagnostics, Inc. | 2018-12-27 |
| IMMULITE/IMMULITE 1000 Free PSA and IMMULITE 2000 Free PSA (P060005/S009) | Siemens Medical Solutions Diagnostics Limited | 2018-12-27 |
| IMMULITE/IMMULITE 1000 AFP and IMMULITE 2000 AFP (P010007/S010) | Siemens Healthcare Diagnostics, Inc. | 2018-12-27 |
| Dimension Vista TPSA Flex reagent cartridge (P000021/S039) | Siemens Healthcare Diagnostics | 2018-12-27 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S037) | Beckman Coulter, Inc. | 2018-12-21 |
| Acess AFP Reagents on the Access Immunoassay Systems (P980041/S041) | Beckman Coulter, Inc. | 2018-12-21 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S022) | Beckman Coulter, Inc. | 2018-12-21 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S049) | Beckman Coulter, Inc. | 2018-12-21 |
| ARCHITECT AFP assay (P120008/S012) | Abbott Laboratories | 2018-12-13 |
| Elecsys total PSA (P990056/S034) | Roche Diagnostics Corp. | 2018-10-25 |
| Atellica IM Alpha Fetoprotein (AFP) (P930036/S009) | Siemens Healthcare Diagnostics, Inc. | 2018-10-25 |
| Atellica IM Complexed PSA (cPSA) (P990055/S017) | Siemens Healthcare Diagnostics | 2018-10-25 |
| Atellica IM Prostate-Specific Antigen (PSA) (P950021/S016) | Siemens Healthcare Diagnostics | 2018-10-25 |
| Elecsys free PSA Test System (P000027/S032) | Roche Diagnostics Corp. | 2018-10-25 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S040) | Beckman Coulter, Inc. | 2018-09-12 |
| AutoDELFIA hAFP Test Kit (P970037/S011) | Revvity, Inc. | 2018-09-06 |
| Atellica IM Prostate-Specific Antigen (PSA) (P950021/S015) | Siemens Healthcare Diagnostics | 2018-08-03 |
| Atellica IM CPSA Assay (P990055/S016) | Siemens Healthcare Diagnostics | 2018-08-03 |
| Elecsys free PSA, free PSA CalSet, and free PSA CalCheck (P000027/S027) | Roche Diagnostics Corp. | 2018-07-27 |
| Elecsys total PSA and total PSA CalSet II (P990056/S028) | Roche Diagnostics Corp. | 2018-07-09 |
| Dimension Vista TPSA Flex reagent cartridge (K6451) (P000021/S038) | Siemens Healthcare Diagnostics | 2018-07-05 |
| Dimension Vista FPSA Flex reagent cartridge (K6452) (P020027/S033) | Siemens Healthcare Diagnostics | 2018-07-05 |
| Elecsys free PSA (P000027/S031) | Roche Diagnostics Corp. | 2018-06-13 |
| Elecsys total PSA (P990056/S033) | Roche Diagnostics Corp. | 2018-06-13 |
| Alere NMP22 BladderChek Test (P940035/S015) | Abbott Diagnostics Scarborough, Inc. | 2018-05-17 |
| Dimension TPSA Flex Reagent Cartridge (P000021/S037) | Siemens Healthcare Diagnostics | 2018-05-14 |
| Dimension FPSA Flex Reagent Cartidge (P020027/S032) | Siemens Healthcare Diagnostics | 2018-05-14 |
| Atellica IM Alpha Fetoprotein (AFP) (P930036/S008) | Siemens Healthcare Diagnostics, Inc. | 2018-05-04 |
| Elecsys Total PSA, Total PSA CalSet ll (P990056/S032) | Roche Diagnostics Corp. | 2018-05-03 |
| Elecsys total PSA (P990056/S031) | Roche Diagnostics Corp. | 2018-04-20 |
| Elecsys free PSA (P000027/S030) | Roche Diagnostics Corp. | 2018-04-20 |
| Immulite/Immulite 1000 PSA/Immulite 2000 PSA (P930027/S019) | Siemens Healthcare Diagnostics, Inc. | 2018-04-16 |
| Dimension TPSA Flex Reagent Cartridge (P000021/S033) | Siemens Healthcare Diagnostics | 2018-04-13 |
| Dimension FPSA Flex Reagent Cartridge (P020027/S028) | Siemens Healthcare Diagnostics | 2018-04-13 |
| ADVIA CENTAUR AFP ASSAY (P930036/S006) | Siemens Healthcare Diagnostics, Inc. | 2018-04-13 |
| Elecsys total PSA (P990056/S029) | Roche Diagnostics Corp. | 2017-12-20 |
| Elecsys free PSA (P000027/S028) | Roche Diagnostics Corp. | 2017-12-20 |
| Dimension Vista TPSA Flex reagent cartridge (K6451) (P000021/S035) | Siemens Healthcare Diagnostics | 2017-12-15 |
| Dimension Vista FPSA Flex reagent cartridge (K6452) (P020027/S030) | Siemens Healthcare Diagnostics | 2017-12-15 |
| Dimension Vista FPSA Flex reagent cartridge (P020027/S029) | Siemens Healthcare Diagnostics | 2017-11-14 |
| Dimension Vista TPSA Flex reagent cartridge (P000021/S034) | Siemens Healthcare Diagnostics | 2017-11-14 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay System (P090026/S021) | Beckman Coulter, Inc. | 2017-10-24 |
| Access AFP Immunoassay (P980041/S039) | Beckman Coulter, Inc. | 2017-10-24 |
| Access Hybritech free PSA Reagents/Calibrator Kit Immunoassay Systems (P970038/S036) | Beckman Coulter, Inc. | 2017-10-24 |
| Access Hybritech PSA Assay (P850048/S048) | Beckman Coulter, Inc. | 2017-10-24 |
| IMMULITE / IMMULITE 1000 Third Generation PSA (P930027/S018) | Siemens Healthcare Diagnostics, Inc. | 2017-10-11 |
| Elecsys Free PSA Immunoassay (P000027/S026) | Roche Diagnostics Corp. | 2017-08-31 |
| Elesys Total PSA Immunoassay (P990056/S027) | Roche Diagnostics Corp. | 2017-08-31 |
| ADVIA CENTAUR PSA ASSAY (P950021/S014) | Siemens Healthcare Diagnostics | 2017-07-27 |
| Dimension FPSA Flex reagent cartridge (RF451) (P020027/S027) | Siemens Healthcare Diagnostics | 2017-07-17 |
| Dimension TPSA Flex reagent cartridge (RF451) (P000021/S032) | Siemens Healthcare Diagnostics | 2017-07-17 |
| Access Hybritech PSA Reagents on the Access Immunoassy Systems (P850048/S046) | Beckman Coulter, Inc. | 2017-07-07 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S019) | Beckman Coulter, Inc. | 2017-07-07 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S034) | Beckman Coulter, Inc. | 2017-07-07 |
| Access AFP Reagents on the Access Immunoassy Systems (P980041/S037) | Beckman Coulter, Inc. | 2017-07-07 |
| Elecsys Anti-HBc IgM Immunoassay (P110025/S019) | Roche Diagnostics Corp. | 2017-06-23 |
| Elecsys free PSA Immunoassay (P000027/S025) | Roche Diagnostics Corp. | 2017-06-23 |
| Elecsys total PSA (100/200 tests) Immunoassay (P990056/S026) | Roche Diagnostics Corp. | 2017-06-23 |
| Elecsys Anti-HBc IgM Immunoassay (P110022/S021) | Roche Diagnostics Corp. | 2017-06-23 |
| Elecsys Anti-HBc IgM Immunoassay (P110031/S018) | Roche Diagnostics Corp. | 2017-06-23 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S036) | Beckman Coulter, Inc. | 2017-06-16 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S033) | Beckman Coulter, Inc. | 2017-06-16 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S018) | Beckman Coulter, Inc. | 2017-06-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S045) | Beckman Coulter, Inc. | 2017-06-16 |
| AutoDELFIA hAFP Test System (P970037/S010) | Revvity, Inc. | 2017-06-07 |
| Dimension FPSA Flex reagent cartridge (RF452) (P020027/S026) | Siemens Healthcare Diagnostics | 2017-05-22 |
| Dimension TPSA Flex reagent cartridge (RF451) (P000021/S031) | Siemens Healthcare Diagnostics | 2017-05-22 |
| ADVIA CENTAUR IMMUNOASSAY (P930036/S007) | Siemens Healthcare Diagnostics, Inc. | 2017-04-26 |
| Axsym Total PSA & Architect Total PSA (P910007/S050) | Abbott Laboratories | 2017-03-28 |
| IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA (P930027/S017) | Siemens Healthcare Diagnostics, Inc. | 2017-03-21 |
| Dimension FPSA Flex reagent cartridge (P020027/S025) | Siemens Healthcare Diagnostics | 2017-03-16 |
| Dimension TPSA Flex reagent cartridge (P000021/S030) | Siemens Healthcare Diagnostics | 2017-03-16 |
| Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM (P110022/S019) | Roche Diagnostics Corp. | 2017-03-03 |
| Elecsys free PSA, free PSA Calset, free PSA CalCheck (P000027/S023) | Roche Diagnostics Corp. | 2017-03-02 |
| Elecsys total PSA, total PSA CalSet II (P990056/S024) | Roche Diagnostics Corp. | 2017-03-02 |
| COBAS E 601 (P110022/S020) | Roche Diagnostics Corp. | 2017-02-28 |
| COBAS E 411 (P110031/S017) | Roche Diagnostics Corp. | 2017-02-28 |
| MODULAR ANALYSTICS E170 (P110025/S018) | Roche Diagnostics Corp. | 2017-02-28 |
| MATRITECH NMP22(TM) TEST KIT (P940035/S014) | Abbott Diagnostics Scarborough, Inc. | 2017-02-27 |
| ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S017) | Beckman Coulter, Inc. | 2017-02-21 |
| ACCESS FREE PSA CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER (P970038/S032) | Beckman Coulter, Inc. | 2017-02-14 |
| ACCESS P2PSA CALIBRATOR ON THE ACCESS IMMUNOASSAY ANALYZER (P090026/S016) | Beckman Coulter, Inc. | 2017-02-14 |
| ACCESS PSA CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER (P850048/S044) | Beckman Coulter, Inc. | 2017-02-14 |
| ACCESS AFP CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER (P980041/S035) | Beckman Coulter, Inc. | 2017-02-14 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM (P110022/S018) | Roche Diagnostics Corp. | 2016-12-14 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM (P110031/S015) | Roche Diagnostics Corp. | 2016-12-14 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM (P110025/S016) | Roche Diagnostics Corp. | 2016-12-14 |
| ELECSYS FREE PSA (P000027/S024) | Roche Diagnostics Corp. | 2016-11-22 |
| ELECSYS TOTAL PSA (P990056/S025) | Roche Diagnostics Corp. | 2016-11-22 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S034) | Beckman Coulter, Inc. | 2016-11-18 |
| TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S043) | Beckman Coulter, Inc. | 2016-11-09 |
| ABBOTT ARCHITECT AFP ASSAY (P120008/S010) | Abbott Laboratories | 2016-10-27 |
| ADVIA CENTAUR CPSA ASSAY (P990055/S015) | Siemens Healthcare Diagnostics | 2016-10-24 |
| DIMENSION VISTA TPSA ASSAY (P000021/S028) | Siemens Healthcare Diagnostics | 2016-10-19 |
| DIMENSION VISTA FPSA ASSAY (P020027/S023) | Siemens Healthcare Diagnostics | 2016-10-19 |
| Alere NMP22 BladderChek Test (P940035/S013) | Abbott Diagnostics Scarborough, Inc. | 2016-09-08 |