| Alinity i HBsAg Next Qualitative assay, Alinity i HBsAg Next Confirmatory assay (P210003/S006) | Abbott Laboratories | 2023-09-28 |
| LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers (P180039/S014) | DiaSorin, Inc. | 2023-09-28 |
| LIAISON® XL MUREX anti-HBc and LIAISON® XL MUREX Control anti-HBc (P180038/S015) | DiaSorin, Inc. | 2023-09-28 |
| LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual (P190017/S015) | DiaSorin, Inc. | 2023-09-28 |
| Alinity m HBV (P200013/S017) | Abbott Molecular, Inc. | 2023-09-14 |
| Alinity m CMV (P210022/S007) | Abbott Molecular, Inc. | 2023-09-14 |
| IMMULITE® 2000 HBsAg, IMMULITE® 2000 HBsAg Confirmatory (P010050/S020) | Siemens Healthcare Diagnostics Products, Ltd. | 2023-08-30 |
| IMMULITE® 2000 Anti-HBs (P010052/S015) | Siemens Healthcare Diagnostics Products, Ltd. | 2023-08-30 |
| IMMULITE® 2000 Anti-HBc IgM (P010053/S015) | Siemens Healthcare Diagnostics Products, Ltd. | 2023-08-30 |
| IMMULITE® 2000 Anti HBc (P010051/S016) | Siemens Healthcare Diagnostics Products, Ltd. | 2023-08-30 |
| cobas® HPV (P190028/S012) | Roche Molecular Systems, Inc. | 2023-08-23 |
| COBAS® AmpliPrep/COBAS® TaqMan® HBV Test (P050028/S088) | Roche Molecular Systems, Inc. | 2023-08-23 |
| cobas® CMV (P160041/S038) | Roche Molecular Systems, Inc. | 2023-08-23 |
| COBAS® AmpliPrep/COBAS® TaqMan® CMV Test (P110037/S059) | Roche Molecular Systems, Inc. | 2023-08-23 |
| cobas® HBV (P150014/S046) | Roche Molecular Systems, Inc. | 2023-08-23 |
| cobas® 4800 HPV Test (P100020/S057) | Roche Molecular Systems, Inc. | 2023-08-23 |
| LIAISON® XL MUREX HBsAg Qual, LIAISON® XL MUREX Control HBsAg (P190017/S014) | DiaSorin, Inc. | 2023-08-22 |
| cobas® HBV (P150014/S044) | Roche Molecular Systems, Inc. | 2023-08-17 |
| cobas® HPV (P190028/S010) | Roche Molecular Systems, Inc. | 2023-08-17 |
| cobas HPV Test, 240 Tests, cobas HPV Test, 960 Tests (P100020/S056) | Roche Molecular Systems, Inc. | 2023-08-17 |
| COBAS® AmpliPrep, COBAS® TaqMan® HBV Test, v2.0 (P050028/S087) | Roche Molecular Systems, Inc. | 2023-08-17 |
| cobas® CMV (P160041/S036) | Roche Molecular Systems, Inc. | 2023-08-17 |
| COBAS® AmpliPrep, COBAS® TaqMan® CMV Test (P110037/S058) | Roche Molecular Systems, Inc. | 2023-08-17 |
| cobas® HBV (P150014/S045) | Roche Molecular Systems, Inc. | 2023-08-16 |
| cobas® CMV (P160041/S037) | Roche Molecular Systems, Inc. | 2023-08-16 |
| cobas® HPV (P190028/S011) | Roche Molecular Systems, Inc. | 2023-08-16 |
| LIAISON QuantiFERON-TB Gold Plus (P180047/S019) | DiaSorin, Inc. | 2023-07-18 |
| Alinity m HBV (P200013/S015) | Abbott Molecular, Inc. | 2023-07-18 |
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S041) | Abbott Laboratories | 2023-07-10 |
| ARCHITECT HBsAg Qualitative/ Qualitative Confirmatory / Alinity i HBsAg Qualitative II/ Qualitative II Confirmatory (P110029/S045) | Abbott Laboratories | 2023-07-10 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S039) | Abbott Laboratories | 2023-07-10 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory (P210003/S008) | Abbott Laboratories | 2023-07-10 |
| ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S054) | Abbott Laboratories, Inc. | 2023-07-10 |
| Aptima HPV Assay (P100042/S035) | Gen-Probe Incorporated | 2023-07-07 |
| ARCHITECT HBsAg Qualitative/HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative/HBsAg Qualitative Confirmatory (P110029/S043) | Abbott Laboratories | 2023-06-23 |
| ARCHITECT AUSAB, Alinity i Anti-HBs (P050051/S052) | Abbott Laboratories, Inc. | 2023-06-22 |
| ARCHITECT HBsAg Qualitative, HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S044) | Abbott Laboratories | 2023-06-22 |
| Alinity m CMV Assay (P210022/S005) | Abbott Molecular, Inc. | 2023-06-16 |
| Alinity m HBV Assay (P200013/S014) | Abbott Molecular, Inc. | 2023-06-16 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck (P190034/S002) | Roche Diagnostics | 2023-06-13 |
| LIAISON® XL MUREX HBsAg Qual Assay (P190017/S012) | DiaSorin, Inc. | 2023-06-07 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S030) | Gen-Probe Incorporated | 2023-06-02 |
| Aptima HPV Assay (P100042/S034) | Gen-Probe Incorporated | 2023-06-02 |
| PyloPlus Urea Breath Test System (P170022/S002) | Arj Medical, Inc. | 2023-05-22 |
| cobas® HPV (P190028/S008) | Roche Molecular Systems, Inc. | 2023-05-16 |
| Elecsys Anti-HBe, PreciControl Anti-HBe (P190005/S002) | Roche Diagnostics | 2023-05-16 |
| LIAISON® XL Murex HBsAg Qual and LIAISON® XL Murex Control HBsAg (P190017/S011) | DiaSorin, Inc. | 2023-05-11 |
| Elecsys Anti-HBc II (P100031/S028) | Roche Diagnostics Corp. | 2023-05-08 |
| ARCHITECT HBsAg Next Qualitative and ARCHITECT HBsAg Next Confirmatory Assay (P210003/S004) | Abbott Laboratories | 2023-05-08 |
| ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2) (P210019/S002) | Siemens Healthcare Diagnostics, Inc. | 2023-04-28 |
| Elecsys HBsAg II, PreciControl HBsAg II, Elecsys HBsAg Confirmatory Test, Elecsys HBsAg II Auto Confirm, PreciControl HB (P160019/S014) | Roche Diagnostics, Inc. | 2023-04-24 |
| Elecsys HBeAg Test System (P130015/S017) | Roche Diagnostics Operations, Inc. | 2023-04-18 |
| LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX HBsAg Confirmatory Test (P190017/S009) | DiaSorin, Inc. | 2023-04-13 |
| BD Onclarity HPV Assay (P160037/S014) | Becton, Dickinson and Company | 2023-04-12 |
| Alinity m CMV (P210022/S004) | Abbott Molecular, Inc. | 2023-03-31 |
| Alinity m HBV (P200013/S013) | Abbott Molecular, Inc. | 2023-03-31 |
| T-SPOT ®.TB (P070006/S019) | Oxford Immunotec, Ltd. | 2023-03-27 |
| T-SPOT.TB Test (P070006/S018) | Oxford Immunotec, Ltd. | 2023-03-20 |
| BD Onclarity HPV Assay (P160037/S015) | Becton, Dickinson and Company | 2023-02-27 |
| cobas® HBV (P150014/S043) | Roche Molecular Systems, Inc. | 2023-02-23 |
| Alinity m HBV (P200013/S010) | Abbott Molecular, Inc. | 2023-02-21 |
| Alinity m CMV (P210022/S003) | Abbott Molecular, Inc. | 2023-02-21 |
| BD Onclarity HPV Assay (P160037/S012) | Becton, Dickinson and Company | 2023-02-15 |
| BD Onclarity HPV Assay (P160037/S008) | Becton, Dickinson and Company | 2023-02-09 |
| ADVIA Centaur® and Atellica IM Hepatitis B Core IgM (AHBcM) Assay (P030040/S022) | Siemens Healthcare Diagnostics | 2023-02-06 |
| LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software (P180047/S021) | DiaSorin, Inc. | 2023-02-01 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S037) | Abbott Laboratories | 2023-01-30 |
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S039) | Abbott Laboratories | 2023-01-30 |
| ARCHITECT HBsAg Next Qualitative / Next Confirmatory (P210003/S005) | Abbott Laboratories | 2023-01-30 |
| ARCHITECT HBsAg Qualitative / HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II / HBsAg Qualitative II Conf (P110029/S041) | Abbott Laboratories | 2023-01-30 |
| ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S049) | Abbott Laboratories, Inc. | 2023-01-30 |
| VITROS Anti-HBc IgM (P030026/S037) | Ortho-Clinical Diagnostics, Inc. | 2023-01-24 |
| QUANTIFERON®-TB Gold Plus Test (P010033/S048) | Qiagen | 2023-01-24 |
| VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S017) | Ortho-Clinical Diagnostics | 2023-01-24 |
| VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S018) | Ortho-Clinical Diagnostics, Inc. | 2023-01-24 |
| Alinity m HBV Assay (P200013/S012) | Abbott Molecular, Inc. | 2023-01-13 |
| RealTime CMV Assay (P160044/S005) | Abbott Molecular | 2023-01-13 |
| Alinity m HBV (P200013/S011) | Abbott Molecular, Inc. | 2022-12-22 |
| LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg (P180048/S010) | DiaSorin, Inc. | 2022-12-21 |
| LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc (P180038/S013) | DiaSorin, Inc. | 2022-12-21 |
| LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software (P180047/S020) | DiaSorin, Inc. | 2022-12-21 |
| LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test (P190017/S008) | DiaSorin, Inc. | 2022-12-21 |
| LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers (P180039/S012) | DiaSorin, Inc. | 2022-12-21 |
| LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe (P180049/S010) | DiaSorin, Inc. | 2022-12-21 |
| LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM (P180045/S010) | DiaSorin, Inc. | 2022-12-21 |
| ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur® HBcT2 Quality Control (HBcT2 QC) (P210019/S001) | Siemens Healthcare Diagnostics, Inc. | 2022-12-20 |
| cobas CMV (P160041/S035) | Roche Molecular Systems, Inc. | 2022-12-14 |
| LIAISON® XL MUREX HBsAg Confirmatory (P190017/S010) | DiaSorin, Inc. | 2022-12-08 |
| LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control anti-HBc (P180038/S014) | DiaSorin, Inc. | 2022-12-08 |
| LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers (P180039/S013) | DiaSorin, Inc. | 2022-12-08 |
| LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S011) | DiaSorin, Inc. | 2022-12-08 |
| LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S011) | DiaSorin, Inc. | 2022-12-08 |
| LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S011) | DiaSorin, Inc. | 2022-12-08 |
| LIAISON® QuantiFERON®-TB Gold Plus and LIAISON® XL Control QuantiFERON®-TB Gold Plus (P180047/S022) | DiaSorin, Inc. | 2022-12-08 |
| ARCHITECT HBsAg Qualitative/Confirmatory/Alinity HBsAg Qualitative II/Confirmatory (P110029/S040) | Abbott Laboratories | 2022-12-07 |
| ARCHITECT AUSAB/Alinity i Anti-HBs (P050051/S048) | Abbott Laboratories, Inc. | 2022-12-07 |
| BD Onclarity HPV Assay (P160037/S013) | Becton, Dickinson and Company | 2022-12-07 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory (P210003/S003) | Abbott Laboratories | 2022-12-07 |
| PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer (P170022/S001) | Arj Medical, Inc. | 2022-11-30 |
| Alinity m CMV (P210022/S002) | Abbott Molecular, Inc. | 2022-11-28 |