| LIAISON QuantiFERON - TB Gold Plus (P180047/S002) | DiaSorin, Inc. | 2020-04-08 |
| T SPOT .TB Test (P070006/S013) | Oxford Immunotec, Ltd. | 2020-04-03 |
| Atellica IM Hepatitis B core IgM (aHBcM) Assay (P030040/S017) | Siemens Healthcare Diagnostics | 2020-04-03 |
| Atellica IM Hepatitis B surface Antigen II (HBs11) and Atellica IM Hepatitis B surface Antigen 11 confirmatory (HBs11 Co (P110041/S009) | Siemens Corp. | 2020-04-03 |
| Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2)Assay (P100039/S009) | Siemens Healthcare Diagnostics, Inc. | 2020-04-03 |
| Atellica IM Anti-Hepatitis B core Total (HBcT) Assay (P040004/S017) | Siemens Healthcare Diagnostics | 2020-04-03 |
| cobas HPV for use on the cobas 6800/8800 Systems (P190028) | Roche Molecular Systems, Inc. | 2020-04-03 |
| Atellica IM Hepatitis B e Antigen (HBeAg) Assay (P090024/S008) | Siemens Healthcare Diagnostics | 2020-04-03 |
| Atellica IM Hepatitis C (aHCV) Assay (P030056/S016) | Siemens Healthcare Diagnostics | 2020-04-03 |
| Alinity m HCV (P190025) | Abbott Molecular, Inc. | 2020-03-23 |
| BD Onclarity HPV Assay (P160037/S006) | Becton, Dickinson and Company | 2020-03-19 |
| ADVIA Centaur and Atellica IM HBeAg (P090024/S007) | Siemens Healthcare Diagnostics | 2020-03-19 |
| ADVIA Centaur HBsAg (P030049/S014) | Siemens Healthcare Diagnostics | 2020-03-19 |
| ADVIA Centaur and Atellica IM HBc IgM (P030040/S016) | Siemens Healthcare Diagnostics | 2020-03-19 |
| ADVIA Centaur and Atellica IM Anti-HBs2 (aHBs2) (P100039/S008) | Siemens Healthcare Diagnostics, Inc. | 2020-03-19 |
| ADVIA Centaur and Atellica IM HBsAgII (P110041/S008) | Siemens Corp. | 2020-03-19 |
| ADVIA Centaur and Atellica IM HBc Total (P040004/S016) | Siemens Healthcare Diagnostics | 2020-03-19 |
| ADVIA Centaur and Atellica IM HCV (P030056/S015) | Siemens Healthcare Diagnostics | 2020-03-19 |
| cobas HPV Test (P100020/S049) | Roche Molecular Systems, Inc. | 2020-03-04 |
| T-SPOT. TB Test (P070006/S012) | Oxford Immunotec, Ltd. | 2020-03-03 |
| Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II (P160019/S010) | Roche Diagnostics, Inc. | 2020-02-27 |
| LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers (P180039) | DiaSorin, Inc. | 2020-02-21 |
| Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0 (P050028/S081) | Roche Molecular Systems, Inc. | 2020-02-20 |
| Cobas AmpliPrep/Cobas Taqman HCV Test v2.0 (P060030/S082) | Roche Molecular Systems, Inc. | 2020-02-20 |
| Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S052) | Roche Molecular Systems, Inc. | 2020-02-20 |
| PyloPlus UBT System (P170022) | Arj Medical, Inc. | 2020-02-18 |
| Aptima HBV Quant Assay (P170025/S015) | Hologic, Inc. | 2020-02-14 |
| Aptima HCV Quant Dx Assay (P160023/S017) | Hologic, Inc. | 2020-02-14 |
| Aptima HCV RNA Qualitative Assay (P020011/S015) | Gen-Probe | 2020-02-14 |
| Aptima HPV Assay (P100042/S029) | Gen-Probe Incorporated | 2020-02-10 |
| cobas CMV (P160041/S028) | Roche Molecular Systems, Inc. | 2020-02-06 |
| cobas HBV (P150014/S035) | Roche Molecular Systems, Inc. | 2020-02-06 |
| cobas HCV (P150015/S037) | Roche Molecular Systems, Inc. | 2020-02-06 |
| Aptima HPV Assay (P100042/S028) | Gen-Probe Incorporated | 2020-01-21 |
| Aptima HCV Quant Dx Assay (P160023/S016) | Hologic, Inc. | 2020-01-21 |
| Aptima HBV Quant Assay (P170025/S014) | Hologic, Inc. | 2020-01-21 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S026) | Gen-Probe Incorporated | 2020-01-21 |
| Alinity i HBsAg Qualitative II, Alinity i HBsAg Qualitative Confirmatory (P110029/S029) | Abbott Laboratories | 2020-01-07 |
| LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc (P180038) | DiaSorin, Inc. | 2020-01-02 |
| IMMULITE 2000 Anti HBc IgM (P010053/S011) | Siemens Healthcare Diagnostics Products, Ltd. | 2019-12-19 |
| IMMULITE 2000 Anti-HBc (P010051/S012) | Siemens Healthcare Diagnostics Products, Ltd. | 2019-12-19 |
| IMMULITE 2000 Anti-HBs (P010052/S013) | Siemens Healthcare Diagnostics Products, Ltd. | 2019-12-19 |
| IMMULITE 2000 HBsAg & HBs Ag Confirmatory (P010050/S017) | Siemens Healthcare Diagnostics Products, Ltd. | 2019-12-19 |
| COBAS HBV TEST (P150014/S034) | Roche Molecular Systems, Inc. | 2019-12-18 |
| COBAS CMV TEST (P160041/S027) | Roche Molecular Systems, Inc. | 2019-12-18 |
| COBAS HCV TEST (P150015/S036) | Roche Molecular Systems, Inc. | 2019-12-18 |
| Aptima HCV Quant Dx Assay (P160023/S015) | Hologic, Inc. | 2019-12-16 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S022) | Gen-Probe Incorporated | 2019-12-16 |
| Aptima HBV Quant Assay (P170025/S013) | Hologic, Inc. | 2019-12-16 |
| Aptima HPV Assay (P100042/S024) | Gen-Probe Incorporated | 2019-12-16 |
| Cobas HBV (P150014/S030) | Roche Molecular Systems, Inc. | 2019-12-11 |
| Cobas CMV (P160041/S023) | Roche Molecular Systems, Inc. | 2019-12-11 |
| Cobas HCV (P150015/S032) | Roche Molecular Systems, Inc. | 2019-12-11 |
| QuantiFERON TB Gold and QuantiFERON-TB Gold Plus (P010033/S046) | Qiagen | 2019-12-06 |
| ARCHITECT AUSAB, LN 1L82 (P050051/S036) | Abbott Laboratories, Inc. | 2019-12-03 |
| LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software (P180047) | DiaSorin, Inc. | 2019-11-26 |
| BD Onclarity HPV Assay (P160037/S003) | Becton, Dickinson and Company | 2019-11-22 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S080) | Roche Molecular Systems, Inc. | 2019-11-05 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S051) | Roche Molecular Systems, Inc. | 2019-11-05 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 (P060030/S081) | Roche Molecular Systems, Inc. | 2019-11-05 |
| ADVIA Centaur HBsAg (P030049/S013) | Siemens Healthcare Diagnostics | 2019-10-25 |
| LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab (P190011) | DiaSorin, Inc. | 2019-10-18 |
| cobas HBV Test (P150014/S033) | Roche Molecular Systems, Inc. | 2019-10-10 |
| Cobas TaqMan HCV Test, v2.0, for Use with the High Pure System and Cobas AmpliPrep, Cobas TaqMan HCV Test, v2.0 (P060030/S080) | Roche Molecular Systems, Inc. | 2019-10-10 |
| cobas HPV Test (P100020/S050) | Roche Molecular Systems, Inc. | 2019-10-10 |
| cobas CMV Test (P160041/S026) | Roche Molecular Systems, Inc. | 2019-10-10 |
| cobas HCV Test (P150015/S035) | Roche Molecular Systems, Inc. | 2019-10-10 |
| Cobas TaqMan HBV Test for Use with the High Pure System and Cobas AmpliPrep, CobasTaqMan HBV Test, v2.0 (P050028/S079) | Roche Molecular Systems, Inc. | 2019-10-10 |
| Cobas AmpliPrep and Cobas TaqMan CMV Test (P110037/S050) | Roche Molecular Systems, Inc. | 2019-10-10 |
| ETI-AB-EBK PLUS assay (P990041/S029) | DiaSorin, Inc. | 2019-09-27 |
| ETI-AB-COREK PLUS assay (P990045/S027) | DiaSorin, Inc. | 2019-09-27 |
| ETI-EBK PLUS Aassay (P990043/S030) | DiaSorin, Inc. | 2019-09-27 |
| ETI-AB-AUK PLUS assay (P990042/S026) | DiaSorin, Inc. | 2019-09-27 |
| ETI MAK-2 PLUS Assay and HBsAg Confirmatory Test (P990038/S030) | DiaSorin, Inc. | 2019-09-27 |
| ETI-CORE-IGMK PLUS assay (P990044/S027) | DiaSorin, Inc. | 2019-09-27 |
| cobas HBV (P150014/S032) | Roche Molecular Systems, Inc. | 2019-09-26 |
| cobas CMV (P160041/S025) | Roche Molecular Systems, Inc. | 2019-09-26 |
| cobas HCV (P150015/S034) | Roche Molecular Systems, Inc. | 2019-09-26 |
| Versant HCV Genotype 2.0 Assay (LiPA) (P160016/S004) | Fujirebio Europe N.V. | 2019-09-20 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S024) | Gen-Probe Incorporated | 2019-09-16 |
| Aptima HPV Assay (P100042/S026) | Gen-Probe Incorporated | 2019-09-16 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test V2.0 (P060030/S079) | Roche Molecular Systems, Inc. | 2019-09-12 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S078) | Roche Molecular Systems, Inc. | 2019-09-12 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S049) | Roche Molecular Systems, Inc. | 2019-09-12 |
| OraQuick HCV Rapid Antibody Test (P080027/S035) | OraSure Technologies, Inc. | 2019-09-11 |
| cobas HBV Test (P150014/S031) | Roche Molecular Systems, Inc. | 2019-09-04 |
| Cobas CMV (P160041/S024) | Roche Molecular Systems, Inc. | 2019-09-04 |
| cobas HCV (P150015/S033) | Roche Molecular Systems, Inc. | 2019-09-04 |
| cobas HPV (P100020/S048) | Roche Molecular Systems, Inc. | 2019-09-03 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S023) | Gen-Probe Incorporated | 2019-08-27 |
| Aptima HPV Assay (P100042/S025) | Gen-Probe Incorporated | 2019-08-27 |
| cobas AmpliPrep/cobas TaqMan CMV Test (P110037/S048) | Roche Molecular Systems, Inc. | 2019-08-13 |
| Architect Anti-HCV and Alinity i Anti-HCV (P050042/S039) | Abbott Laboratories, Inc. | 2019-08-13 |
| cobas AmpliPrep/cobas TaqMan HBV Test, v2 (P050028/S077) | Roche Molecular Systems, Inc. | 2019-08-13 |
| cobas AmpliPrep/cobas TaqMan HCV Test, v2 (P060030/S078) | Roche Molecular Systems, Inc. | 2019-08-13 |
| ETI-EBK Plus Assay (P990043/S029) | DiaSorin, Inc. | 2019-07-18 |
| ETI-AB-AUK Plus Assay (P990042/S025) | DiaSorin, Inc. | 2019-07-18 |
| ETI-MAK-2 Plus Assay (P990038/S029) | DiaSorin, Inc. | 2019-07-18 |
| ETI-AB-EBK Plus Assay (P990041/S028) | DiaSorin, Inc. | 2019-07-18 |
| ETI-CORE-IGMK Plus Assay (P990044/S026) | DiaSorin, Inc. | 2019-07-18 |