| Atellica IM Total PSA II (tPSAII) (P240021) | Siemens Healthcare Diagnostics, Inc. | 2025-12-03 |
| IMMULITE 2000 PSA (P930027/S037) | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |
| IMMULITE 2000 AFP (P010007/S024) | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |
| Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) (P100039/S018) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| Atellica IM Anti-HBe2 (aHBe2) (P200017/S005) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| Atellica IM HBc Total 2 (HBcT2) (P210019/S004) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| IMMULITE 2000 Prostate-Specific Antigen (PSA) (P930027/S036) | Siemens Healthcare Diagnostics, Inc. | 2025-08-14 |
| ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (P930036/S025) | Siemens Healthcare Diagnostics, Inc. | 2025-07-16 |
| IMMULITE 2000 Alpha-Fetoprotein (AFP) (P010007/S023) | Siemens Healthcare Diagnostics, Inc. | 2025-04-11 |
| Atellica IM Anti-HBe2 (aHBe2) (P200017/S003) | Siemens Healthcare Diagnostics, Inc. | 2025-03-20 |
| Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2); Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control ( (P100039/S016) | Siemens Healthcare Diagnostics, Inc. | 2025-02-26 |
| 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 |
| Atellica IM Alpha Fetoprotein (AFP) (P930036/S024) | Siemens Healthcare Diagnostics, Inc. | 2024-09-23 |
| Atellica IM HBc Total 2 (HBcT2) (P210019/S003) | Siemens Healthcare Diagnostics, Inc. | 2024-07-22 |
| Atellica IM Alpha Fetoprotein (AFP) (P930036/S021) | Siemens Healthcare Diagnostics, Inc. | 2024-02-08 |
| 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 |
| IMMULITE® AFP, IMMULITE® 2000 AFP (P010007/S016) | Siemens Healthcare Diagnostics, Inc. | 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 |
| ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2) (P210019/S002) | Siemens Healthcare Diagnostics, Inc. | 2023-04-28 |
| ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur® HBcT2 Quality Control (HBcT2 QC) (P210019/S001) | Siemens Healthcare Diagnostics, Inc. | 2022-12-20 |
| 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 |
| ADVIA Centaur (XP/XPT, CP) AFP; Atellica IM AFP (P930036/S020) | Siemens Healthcare Diagnostics, Inc. | 2022-09-30 |
| ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2) (P210019) | Siemens Healthcare Diagnostics, Inc. | 2022-07-27 |
| 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 Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay (P100039/S015) | Siemens Healthcare Diagnostics, Inc. | 2022-03-29 |
| IMMULITE/IMMULITE 1000 AFP, IMMULITE 2000 AFP (P010007/S015) | Siemens Healthcare Diagnostics, Inc. | 2022-03-29 |
| Atellica® IM Anti-HBe2 Assay (P200017/S002) | Siemens Healthcare Diagnostics, Inc. | 2022-03-29 |
| ADVIA Centaur anti-HBs2 (aHBs2), Atellica IM aHBs2 (P100039/S014) | Siemens Healthcare Diagnostics, Inc. | 2022-02-16 |
| ADVIA Centaur Anti-HBe2 (AHBe2) Assay (P200017/S001) | Siemens Healthcare Diagnostics, Inc. | 2022-01-06 |
| Atellica® IM Alpha Fetoprotein (AFP) Assay (P930036/S018) | Siemens Healthcare Diagnostics, Inc. | 2021-11-09 |
| Atellica® IM Alpha Fetoprotein (AFP) Assay (P930036/S017) | Siemens Healthcare Diagnostics, Inc. | 2021-08-25 |
| ADVIA Centaur Anti-HBe2 (aHBe2) assay (P200017) | Siemens Healthcare Diagnostics, Inc. | 2021-07-14 |
| 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 |
| Atellica IM Alpha Fetoprotein (AFP) Assay (P930036/S016) | Siemens Healthcare Diagnostics, Inc. | 2021-04-27 |
| Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay (P100039/S013) | Siemens Healthcare Diagnostics, Inc. | 2021-04-27 |
| ADVIA Centaur aHBs2 Assay (P100039/S012) | Siemens Healthcare Diagnostics, Inc. | 2021-04-13 |
| ADVIA Centaur anti-HBs2 (aHBs2), ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material, Atellica IM Anti-Hepatitis B (P100039/S011) | Siemens Healthcare Diagnostics, Inc. | 2021-03-11 |
| 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 |
| ADVIA Centaur aHBs2 Readypack Reagents and Quality Control Materials (P100039/S010) | Siemens Healthcare Diagnostics, Inc. | 2020-08-25 |
| ADVIA Centaur AFP Readypack Reagents (P930036/S015) | Siemens Healthcare Diagnostics, Inc. | 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 |
| Advia Centaur AFP Immunoassay and Atellica IM AFP Immunoassay (P930036/S012) | Siemens Healthcare Diagnostics, Inc. | 2020-07-02 |
| Atellica IM Alpha Fetoprotien (AFP) Assay (P930036/S014) | Siemens Healthcare Diagnostics, Inc. | 2020-04-03 |
| Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2)Assay (P100039/S009) | Siemens Healthcare Diagnostics, Inc. | 2020-04-03 |
| ADVIA Centaur and Atellica IM AFP (P930036/S013) | Siemens Healthcare Diagnostics, Inc. | 2020-03-19 |
| ADVIA Centaur and Atellica IM Anti-HBs2 (aHBs2) (P100039/S008) | Siemens Healthcare Diagnostics, Inc. | 2020-03-19 |
| 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 Systems PSA, IMMULITE 2000 Systems PSA & IMMULITE Systems Third Generation PSA (P930027/S021) | Siemens Healthcare Diagnostics, Inc. | 2019-07-11 |
| Atellica IM Alpha Fetoprotein (AFP) Assay (P930036/S011) | Siemens Healthcare Diagnostics, Inc. | 2019-03-08 |
| Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay (P100039/S007) | Siemens Healthcare Diagnostics, Inc. | 2019-03-08 |
| Atellica IM Alpha Fetoprotein (AFP) (P930036/S010) | Siemens Healthcare Diagnostics, Inc. | 2019-03-07 |
| 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 AFP and IMMULITE 2000 AFP (P010007/S010) | Siemens Healthcare Diagnostics, Inc. | 2018-12-27 |
| Atellica IM Alpha Fetoprotein (AFP) (P930036/S009) | Siemens Healthcare Diagnostics, Inc. | 2018-10-25 |
| Atellica IM Anti-Hepatitis B Surface Antigen 2 (aHBs2) (P100039/S006) | Siemens Healthcare Diagnostics, Inc. | 2018-09-11 |
| Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2), Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control ( (P100039/S005) | Siemens Healthcare Diagnostics, Inc. | 2018-05-23 |
| Atellica IM Alpha Fetoprotein (AFP) (P930036/S008) | Siemens Healthcare Diagnostics, Inc. | 2018-05-04 |
| Immulite/Immulite 1000 PSA/Immulite 2000 PSA (P930027/S019) | Siemens Healthcare Diagnostics, Inc. | 2018-04-16 |
| ADVIA CENTAUR AFP ASSAY (P930036/S006) | Siemens Healthcare Diagnostics, Inc. | 2018-04-13 |
| IMMULITE / IMMULITE 1000 Third Generation PSA (P930027/S018) | Siemens Healthcare Diagnostics, Inc. | 2017-10-11 |
| ADVIA CENTAUR IMMUNOASSAY (P930036/S007) | Siemens Healthcare Diagnostics, Inc. | 2017-04-26 |
| IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA (P930027/S017) | Siemens Healthcare Diagnostics, Inc. | 2017-03-21 |
| ADVIA CENTAUR ANTI HBS2 ASSAY (P100039/S004) | Siemens Healthcare Diagnostics, Inc. | 2016-08-20 |
| ADVIA CENTAUR ANTI-HBS2 (AL-BS2) ASSAY (P100039/S003) | Siemens Healthcare Diagnostics, Inc. | 2015-07-10 |
| IMMULITE PSA KIT/ IMMULITE 2000 PSA KIT (P930027/S016) | Siemens Healthcare Diagnostics, Inc. | 2014-12-02 |
| VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S010) | Siemens Healthcare Diagnostics, Inc. | 2013-12-23 |
| ADVIA CENTAUR ANTI-HBS2 ASSAY (P100039/S001) | Siemens Healthcare Diagnostics, Inc. | 2013-10-03 |
| ADVIA CENTAUR ANTI-HBS2 MASTER CURVE MATERIALS (P100039/S002) | Siemens Healthcare Diagnostics, Inc. | 2013-09-26 |
| IMMULITE PSA ASSAY (P930027/S015) | Siemens Healthcare Diagnostics, Inc. | 2012-11-08 |
| IMMULITE AFP ASSAY (P010007/S009) | Siemens Healthcare Diagnostics, Inc. | 2012-11-08 |
| VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S011) | Siemens Healthcare Diagnostics, Inc. | 2012-10-24 |
| ADVIA CENTAUR AFP ASSAY (P930036/S005) | Siemens Healthcare Diagnostics, Inc. | 2012-10-15 |
| ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS (P930036/S004) | Siemens Healthcare Diagnostics, Inc. | 2012-08-14 |
| AFP IMMULITE SUBSTRATE REAGENT (P010007/S008) | Siemens Healthcare Diagnostics, Inc. | 2012-04-05 |
| PSA IMMULITE SUBSTRATE REAGENT (P930027/S014) | Siemens Healthcare Diagnostics, Inc. | 2012-04-05 |
| ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL (P100039) | Siemens Healthcare Diagnostics, Inc. | 2012-01-20 |
| IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP (P010007/S007) | Siemens Healthcare Diagnostics, Inc. | 2011-09-12 |
| IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 & 2000 THIRD GENERATION PSA (P930027/S013) | Siemens Healthcare Diagnostics, Inc. | 2011-09-12 |
| PSA IMMULITE ASSAY (P930027/S012) | Siemens Healthcare Diagnostics, Inc. | 2011-09-07 |
| AFP IMMULITE ASSAY (P010007/S006) | Siemens Healthcare Diagnostics, Inc. | 2011-09-07 |
| IMMULITE/IMMULITE 2000 PSA (P930027/S011) | Siemens Healthcare Diagnostics, Inc. | 2011-04-26 |
| IMMULITE/IMMULITE 2000 AFP (P010007/S005) | Siemens Healthcare Diagnostics, Inc. | 2011-04-26 |
| SIEMENS IMMULITE PSA AND THIRD GENERATION PSA ASSAYS ON THE IMMULITE, IMMULITE 1000, 2000 AND IMMULITE 2500 ANALYZERS (P930027/S008) | Siemens Healthcare Diagnostics, Inc. | 2010-02-25 |
| IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 AFP (P010007/S004) | Siemens Healthcare Diagnostics, Inc. | 2010-01-21 |
| IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 PSA & 3RD GENERATION PSA (P930027/S010) | Siemens Healthcare Diagnostics, Inc. | 2010-01-21 |
| VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S009) | Siemens Healthcare Diagnostics, Inc. | 2009-12-23 |
| VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S008) | Siemens Healthcare Diagnostics, Inc. | 2009-05-01 |
| VERSANT HCV RNA 3.0 (BDNA) WITH VERSANT 440 MOLECULAR SYSTEM (P020022/S007) | Siemens Healthcare Diagnostics, Inc. | 2009-04-14 |
| IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 PSA & 3RD GENERATIONPSA (P930027/S007) | Siemens Healthcare Diagnostics, Inc. | 2008-12-30 |
| VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S006) | Siemens Healthcare Diagnostics, Inc. | 2007-12-14 |
| BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S005) | Siemens Healthcare Diagnostics, Inc. | 2007-08-01 |
| BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S004) | Siemens Healthcare Diagnostics, Inc. | 2006-03-03 |
| BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S003) | Siemens Healthcare Diagnostics, Inc. | 2006-02-17 |