| DIMENSION FPSA FLEX REAGENT CARTRIDGE (RF452) (P020027/S024) | Siemens Healthcare Diagnostics | 2016-08-30 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (RF451) (P000021/S029) | Siemens Healthcare Diagnostics | 2016-08-30 |
| ACCESS PSA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (P850048/S042) | Beckman Coulter, Inc. | 2016-08-26 |
| AUTODELFIA HAFP TEST SYSTEM (P970037/S009) | Revvity, Inc. | 2016-08-23 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY (P110022/S015) | Roche Diagnostics Corp. | 2016-08-08 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY (P110025/S013) | Roche Diagnostics Corp. | 2016-08-08 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY (P110031/S012) | Roche Diagnostics Corp. | 2016-08-08 |
| VIDAS TOTAL PSA (P040008/S013) | bioMerieux, Inc. | 2016-05-31 |
| ALERE NMP22(TM) TEST (P940035/S012) | Abbott Diagnostics Scarborough, Inc. | 2016-05-06 |
| ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S023) | Roche Diagnostics Corp. | 2016-03-16 |
| ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S022) | Roche Diagnostics Corp. | 2016-03-16 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA (P110025/S015) | Roche Diagnostics Corp. | 2016-03-16 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM (P110022/S017) | Roche Diagnostics Corp. | 2016-03-16 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM (P110031/S014) | Roche Diagnostics Corp. | 2016-03-16 |
| ELECSYS ANTI-HBC IGM TEST SYSTEM (P110022/S016) | Roche Diagnostics Corp. | 2016-02-24 |
| ELECSYS ANTI-HBC IGM TEST SYSTEM (P110025/S014) | Roche Diagnostics Corp. | 2016-02-24 |
| ELECSYS ANTI-HBC IGM TEST SYSTEM (P110031/S013) | Roche Diagnostics Corp. | 2016-02-24 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE (P020027/S022) | Siemens Healthcare Diagnostics | 2015-12-15 |
| DIMENSION TPSA FLEX REAGENT CARTRIGE AND DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE (P000021/S027) | Siemens Healthcare Diagnostics | 2015-12-15 |
| ELECSYS ANTI-HBC-IGM (P110025/S012) | Roche Diagnostics Corp. | 2015-11-24 |
| ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S022) | Roche Diagnostics Corp. | 2015-11-24 |
| ELECSYS ANTI-HBC-IGM (P110031/S011) | Roche Diagnostics Corp. | 2015-11-24 |
| ELECSYS FREE PSA IMMUNOASSAY (P000027/S021) | Roche Diagnostics Corp. | 2015-11-24 |
| ELECSYS ANTI-HBC-IGM (P110022/S014) | Roche Diagnostics Corp. | 2015-11-24 |
| ARCHITECT FREE PSA (LN 6C07) (P980007/S040) | Abbott Laboratories | 2015-08-13 |
| ARCHITECT TOTAL PSA (LN 6C06) (P910007/S049) | Abbott Laboratories | 2015-08-13 |
| ARCHITECT AFP (LN 3P36) (P120008/S009) | Abbott Laboratories | 2015-08-13 |
| VIDAS TOTAL PSA ASSAY (P040008/S012) | bioMerieux, Inc. | 2015-08-05 |
| ALERE NMP22 BLADDERCHEK TEST (P940035/S011) | Abbott Diagnostics Scarborough, Inc. | 2015-07-28 |
| ARCHITECT AFP ASSAY (LN 3P36) (P120008/S008) | Abbott Laboratories | 2015-07-13 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S033) | Beckman Coulter, Inc. | 2015-07-08 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S041) | Beckman Coulter, Inc. | 2015-06-23 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S032) | Beckman Coulter, Inc. | 2015-06-23 |
| ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S015) | Beckman Coulter, Inc. | 2015-06-23 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S031) | Beckman Coulter, Inc. | 2015-06-23 |
| ACCESS HYBRITECH FREE PSA REAGENT ASSAY (P970038/S030) | Beckman Coulter, Inc. | 2015-06-09 |
| VIDAS TOTAL PSA (P040008/S011) | bioMerieux, Inc. | 2015-04-22 |
| ARCHITECT FREE PSA (LN 6C07) (P980007/S039) | Abbott Laboratories | 2015-03-26 |
| ARCHITECT TOTAL PSA (LN 6C06) (P910007/S048) | Abbott Laboratories | 2015-03-26 |
| ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT (P970038/S029) | Beckman Coulter, Inc. | 2015-03-20 |
| ACCESS HYBRITECH PSA ASSAY (P850048/S040) | Beckman Coulter, Inc. | 2015-03-20 |
| ACCESS HYBRITECH P2SA REAGENTS ON THE ACCESS IMMUNCASSAY SYSTEM (P090026/S014) | Beckman Coulter, Inc. | 2015-03-20 |
| ACCESS AFP IMMUNOASSAY SYSTEM (P980041/S030) | Beckman Coulter, Inc. | 2015-03-20 |
| ACCESS HYBRITECH PSA ASSAY (P850048/S038) | Beckman Coulter, Inc. | 2014-12-23 |
| ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT (P970038/S027) | Beckman Coulter, Inc. | 2014-12-23 |
| ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S012) | Beckman Coulter, Inc. | 2014-12-23 |
| ACCESS AFP IMMUNOASSAY SYSTEM (P980041/S028) | Beckman Coulter, Inc. | 2014-12-23 |
| ELECSYS FREE PSA CALCHECK (P000027/S020) | Roche Diagnostics Corp. | 2014-12-22 |
| ARCHITECT FREE PSA (P980007/S037) | Abbott Laboratories | 2014-12-11 |
| ARCHITECT TOTAL PSA (P910007/S046) | Abbott Laboratories | 2014-12-11 |
| ARCHITECT AFP (P120008/S007) | Abbott Laboratories | 2014-12-11 |
| ARCHITECT TOTAL PSA (LN 6CO6) (P910007/S047) | Abbott Laboratories | 2014-12-08 |
| ARCHITECT FREE PSA (LN 6C07) (P980007/S038) | Abbott Laboratories | 2014-12-08 |
| ACCESS AFP ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S031) | Beckman Coulter, Inc. | 2014-12-08 |
| IMMULITE PSA KIT/ IMMULITE 2000 PSA KIT (P930027/S016) | Siemens Healthcare Diagnostics, Inc. | 2014-12-02 |
| ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170 (P110025/S011) | Roche Diagnostics Corp. | 2014-11-26 |
| ELECSYS ANTI-HBC IGM ON COBAS E 601 (P110022/S013) | Roche Diagnostics Corp. | 2014-11-26 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S029) | Beckman Coulter, Inc. | 2014-10-24 |
| ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S013) | Beckman Coulter, Inc. | 2014-10-24 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S028) | Beckman Coulter, Inc. | 2014-10-24 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S039) | Beckman Coulter, Inc. | 2014-10-24 |
| DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE (P000021/S026) | Siemens Healthcare Diagnostics | 2014-09-25 |
| DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE (P020027/S021) | Siemens Healthcare Diagnostics | 2014-09-25 |
| ACCESS HYBRITECH P2PSA ON TH ACCESS IMMNUNOASSAY SYSTEM (P090026/S011) | Beckman Coulter, Inc. | 2014-07-07 |
| ARCHITECT TOTAL PSA (LN 6C06) (P910007/S045) | Abbott Laboratories | 2014-06-18 |
| ARCHITECT FREE PSA (LN 6C07) (P980007/S036) | Abbott Laboratories | 2014-06-18 |
| ELECSYS FREE PSA (P000027/S019) | Roche Diagnostics Corp. | 2014-06-12 |
| ELECSYS TOTAL PSA (P990056/S021) | Roche Diagnostics Corp. | 2014-06-12 |
| ELESYS ANTI-HBC IGM (P110022/S012) | Roche Diagnostics Corp. | 2014-06-12 |
| ARCHITECT TOTAL PSA (P910007/S044) | Abbott Laboratories | 2014-05-28 |
| ARCHITECT TOTAL PSA (P910007/S043) | Abbott Laboratories | 2014-05-16 |
| ARCHITECT FREE PSA (P980007/S034) | Abbott Laboratories | 2014-05-16 |
| ARCHITECT FREE PSA (P980007/S035) | Abbott Laboratories | 2014-05-13 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S027) | Beckman Coulter, Inc. | 2014-05-01 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S026) | Beckman Coulter, Inc. | 2014-05-01 |
| ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S010) | Beckman Coulter, Inc. | 2014-05-01 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S037) | Beckman Coulter, Inc. | 2014-05-01 |
| ARCHITECT AFP (P120008/S006) | Abbott Laboratories | 2014-04-15 |
| ELECSYS FREE PSA IMMUNOASSAY (P000027/S018) | Roche Diagnostics Corp. | 2014-03-21 |
| ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S020) | Roche Diagnostics Corp. | 2014-03-21 |
| VIDAS TOTAL PSA (TPSA) ASSAY (P040008/S008) | bioMerieux, Inc. | 2014-03-06 |
| ARCHITECT FREE PSA (P980007/S033) | Abbott Laboratories | 2014-02-03 |
| ARCHITECT TOTAL PSA (P910007/S042) | Abbott Laboratories | 2014-02-03 |
| ELECSYS ANTI-HBC IGM TEST SYSTEM (P110022/S008) | Roche Diagnostics Corp. | 2013-12-20 |
| ARCHITECT AFP (P120008/S005) | Abbott Laboratories | 2013-11-26 |
| ARCHITECT FREE PSA (P980007/S031) | Abbott Laboratories | 2013-11-26 |
| ARCHITECT TOTAL PSA (P910007/S040) | Abbott Laboratories | 2013-11-26 |
| ARCHITECT TOTAL PSA (P910007/S041) | Abbott Laboratories | 2013-11-26 |
| ARCHITECT AFP (P120008/S004) | Abbott Laboratories | 2013-11-26 |
| ARCHITECT FREE PSA (P980007/S032) | Abbott Laboratories | 2013-11-26 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S024) | Beckman Coulter, Inc. | 2013-10-17 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S025) | Beckman Coulter, Inc. | 2013-10-17 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S035) | Beckman Coulter, Inc. | 2013-10-17 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S025) | Beckman Coulter, Inc. | 2013-10-17 |
| ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S008) | Beckman Coulter, Inc. | 2013-10-17 |
| ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S009) | Beckman Coulter, Inc. | 2013-10-17 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S026) | Beckman Coulter, Inc. | 2013-10-17 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S036) | Beckman Coulter, Inc. | 2013-10-17 |
| VIDAS TOTAL PSA (TPSA) ASSAY (P040008/S007) | bioMerieux, Inc. | 2013-09-12 |
| ARCHITECT AFP ASSAY (P120008/S002) | Abbott Laboratories | 2013-08-27 |