| Aptima HPV 16 18/45 Genotype Assay (P120007/S018) | Gen-Probe Incorporated | 2019-02-28 |
| Aptima HPV Assay (P100042/S020) | Gen-Probe Incorporated | 2019-02-28 |
| Aptima HCV Quant Dx Assay (P160023/S009) | Hologic, Inc. | 2019-02-28 |
| Aptima HBV Quant Assay (P170025/S007) | Hologic, Inc. | 2019-02-28 |
| ARCHITECT Anti-HCV Reagent Kit (P050042/S038) | Abbott Laboratories, Inc. | 2019-01-24 |
| QuantiFERON - TB Gold Test, QuantiFERON - TB Gold Plus Test (P010033/S042) | Qiagen | 2019-01-04 |
| cobas HPV Test (P100020/S042) | Roche Molecular Systems, Inc. | 2019-01-02 |
| cobas HBV (P150014/S023) | Roche Molecular Systems, Inc. | 2019-01-02 |
| cobas CMV (P160041/S016) | Roche Molecular Systems, Inc. | 2019-01-02 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test (P060030/S072) | Roche Molecular Systems, Inc. | 2019-01-02 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S044) | Roche Molecular Systems, Inc. | 2019-01-02 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test (P050028/S073) | Roche Molecular Systems, Inc. | 2019-01-02 |
| cobas HCV (P150015/S023) | Roche Molecular Systems, Inc. | 2019-01-02 |
| Aptima HBV Quant Assay (P170025/S006) | Hologic, Inc. | 2018-12-28 |
| Aptima HCV Quant Dx Assay (P160023/S008) | Hologic, Inc. | 2018-12-28 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S028) | Ortho-Clinical Diagnostics | 2018-12-17 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S031) | Ortho-Clinical Diagnostics, Inc. | 2018-12-17 |
| VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S034) | Ortho-Clinical Diagnostics, Inc. | 2018-12-17 |
| VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S016) | Ortho-Clinical Diagnostics, Inc. | 2018-12-17 |
| VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator (P030026/S035) | Ortho-Clinical Diagnostics, Inc. | 2018-12-17 |
| VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S015) | Ortho-Clinical Diagnostics | 2018-12-17 |
| VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit (P000044/S039) | Ortho-Clinical Diagnostics, Inc. | 2018-12-17 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure System (P060030/S071) | Roche Molecular Systems, Inc. | 2018-12-13 |
| cobas CMV (P160041/S015) | Roche Molecular Systems, Inc. | 2018-12-13 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System (P050028/S072) | Roche Molecular Systems, Inc. | 2018-12-13 |
| cobas HCV (P150015/S022) | Roche Molecular Systems, Inc. | 2018-12-13 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S043) | Roche Molecular Systems, Inc. | 2018-12-13 |
| cobas HBV (P150014/S022) | Roche Molecular Systems, Inc. | 2018-12-13 |
| cobas HPV Test (P100020/S041) | Roche Molecular Systems, Inc. | 2018-12-11 |
| cobas HBV (P150014/S021) | Roche Molecular Systems, Inc. | 2018-12-07 |
| cobas HPV Test (P100020/S040) | Roche Molecular Systems, Inc. | 2018-12-07 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System (P050028/S071) | Roche Molecular Systems, Inc. | 2018-12-07 |
| cobas HCV (P150015/S021) | Roche Molecular Systems, Inc. | 2018-12-07 |
| cobas CMV (P160041/S014) | Roche Molecular Systems, Inc. | 2018-12-07 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S042) | Roche Molecular Systems, Inc. | 2018-12-07 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV TEst, v2.0 for use on the High Pure System (P060030/S070) | Roche Molecular Systems, Inc. | 2018-12-07 |
| OraQuick HCV Rapid Antibody Test (P080027/S034) | OraSure Technologies, Inc. | 2018-12-06 |
| cobas HPV Test (P100020/S039) | Roche Molecular Systems, Inc. | 2018-11-23 |
| ARCHITECT CORE-M (LN 6l23), Calibrators, Controls and Reagent Kit (P060035/S027) | Abbott Laboratories | 2018-11-20 |
| Cervista HPV 16/18 Assay (P080015/S016) | Hologic, Inc. | 2018-11-15 |
| Cervista HPV HR Assay (P080014/S024) | Hologic, Inc. | 2018-11-15 |
| ARCHITECT AUSAB (LN 1L82) (P050051/S034) | Abbott Laboratories, Inc. | 2018-11-14 |
| ARCHITECT HBsAg Qualitative (LN 4P53) and HBsAg Qualitative Confirmatory (LN 4P54) (P110029/S028) | Abbott Laboratories | 2018-11-14 |
| ARCHITECT Anti-HCV (LN 1L79) (P050042/S037) | Abbott Laboratories, Inc. | 2018-11-09 |
| ARCHITECT CORE (LN 6L22) (P080023/S030) | Abbott Laboratories | 2018-11-09 |
| Architect Anti-HCV Regent Kit (100, 500 Test) (P050042/S036) | Abbott Laboratories, Inc. | 2018-11-07 |
| Elecsys Anti-HBc II (P100032/S019) | Roche Diagnostics Corp. | 2018-11-06 |
| Elecsys Anti-HBc II (P100031/S025) | Roche Diagnostics Corp. | 2018-11-06 |
| Elecsys ANti-HBs (P010054/S039) | Roche Diagnostics Corp. | 2018-11-06 |
| Elecsys HBsAg II (100/200 tests) (P160019/S008) | Roche Diagnostics, Inc. | 2018-11-06 |
| Elecsys HBeAg (P130015/S016) | Roche Diagnostics Operations, Inc. | 2018-11-06 |
| Elecsys Anti-HBc IgM (P110022/S026) | Roche Diagnostics Corp. | 2018-11-06 |
| Elecsys ANti-HCV II (100/200 tests) (P140021/S015) | Roche Diagnostics Operations, Inc. | 2018-11-06 |
| Elecsys Anti-HBc IgM (P110031/S023) | Roche Diagnostics Corp. | 2018-11-06 |
| Elecsys Anti-HBc IgM (P110025/S022) | Roche Diagnostics Corp. | 2018-11-06 |
| Aptima HBV Quant Assay (P170025/S005) | Hologic, Inc. | 2018-10-31 |
| Aptima HCV Quant DX Assay (P160023/S007) | Hologic, Inc. | 2018-10-31 |
| Aptima HCV RNA Qualitative Assay (P020011/S011) | Gen-Probe | 2018-10-31 |
| QuantiFERON-TB Gold Test / QuantiFERON TB Gold Plus Test (P010033/S041) | Qiagen | 2018-10-30 |
| ARCHITECT Anti-HCV (P050042/S035) | Abbott Laboratories, Inc. | 2018-10-19 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S027) | Ortho-Clinical Diagnostics | 2018-10-16 |
| Aptima HBV Quant Assay (P170025/S004) | Hologic, Inc. | 2018-10-16 |
| Aptima HCV Quant Dx Assay (P160023/S004) | Hologic, Inc. | 2018-10-16 |
| Cervista HPV 16/18 Assay (P080015/S015) | Hologic, Inc. | 2018-10-09 |
| Cervista® HPV HR Assay (P080014/S023) | Hologic, Inc. | 2018-10-09 |
| QuantiFERON TB Gold Test, QuantiFERON TB Gold Test (reference lab pack), QuantiFERON TB Gold Plus Test, QuantiFERON TB G (P010033/S040) | Qiagen | 2018-10-04 |
| Aptima HBV Quant Assay (P170025/S001) | Hologic, Inc. | 2018-10-02 |
| Aptima HPV Assay (P100042/S019) | Gen-Probe Incorporated | 2018-09-28 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S017) | Gen-Probe Incorporated | 2018-09-28 |
| Aptima HCV Quant Dx Assay (P160023/S006) | Hologic, Inc. | 2018-09-26 |
| artus CMV RGQ MDx Kit and artus CMV QS-RGO MDx Kit (P130027/S006) | Qiagen, Inc. | 2018-09-26 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure System (P060030/S069) | Roche Molecular Systems, Inc. | 2018-09-19 |
| cobas HPV Test (P100020/S038) | Roche Molecular Systems, Inc. | 2018-09-19 |
| cobas HBV (P150014/S020) | Roche Molecular Systems, Inc. | 2018-09-19 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S041) | Roche Molecular Systems, Inc. | 2018-09-19 |
| cobas HCV (P150015/S020) | Roche Molecular Systems, Inc. | 2018-09-19 |
| cobas CMV (P160041/S013) | Roche Molecular Systems, Inc. | 2018-09-19 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System (P050028/S070) | Roche Molecular Systems, Inc. | 2018-09-19 |
| Aptima HPV Assay (P100042/S018) | Gen-Probe Incorporated | 2018-09-13 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S016) | Gen-Probe Incorporated | 2018-09-13 |
| Cervista HPV 16/18 Assay (P080015/S014) | Hologic, Inc. | 2018-09-13 |
| Cervista HPV HR Assay (P080014/S022) | Hologic, Inc. | 2018-09-13 |
| Atellica IM anti-HBc Total (HBcT) (P040004/S014) | Siemens Healthcare Diagnostics | 2018-09-11 |
| Atellica IM HBsAgII (HBsII)/Atellica IM HBsAg Confirmatory (P110041/S006) | Siemens Corp. | 2018-09-11 |
| Atellica IM Analyzer Hepatitis C (aHCV) (P030056/S013) | Siemens Healthcare Diagnostics | 2018-09-11 |
| Atellica IM Anti-Hepatitis B Surface Antigen 2 (aHBs2) (P100039/S006) | Siemens Healthcare Diagnostics, Inc. | 2018-09-11 |
| Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S005) | Siemens Healthcare Diagnostics | 2018-09-11 |
| Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S013) | Siemens Healthcare Diagnostics | 2018-09-11 |
| QuantiFeron TB Gold and QuantiFeron TB Gold Plus (P010033/S037) | Qiagen | 2018-08-24 |
| Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC) (P030040/S014) | Siemens Healthcare Diagnostics | 2018-08-24 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure System (P060030/S068) | Roche Molecular Systems, Inc. | 2018-08-17 |
| cobas HCV (P150015/S018) | Roche Molecular Systems, Inc. | 2018-08-17 |
| cobas CMV (P160041/S012) | Roche Molecular Systems, Inc. | 2018-08-17 |
| cobas HBV (P150014/S019) | Roche Molecular Systems, Inc. | 2018-08-17 |
| Roche COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System (P050028/S069) | Roche Molecular Systems, Inc. | 2018-08-17 |
| cobas HPV Test (P100020/S037) | Roche Molecular Systems, Inc. | 2018-08-17 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S040) | Roche Molecular Systems, Inc. | 2018-08-17 |
| Cervista HPV HR Assay (P080014/S021) | Hologic, Inc. | 2018-08-16 |
| Cervista HPV 16/18 Assay (P080015/S013) | Hologic, Inc. | 2018-08-16 |
| ARCHITECT CORE, LN 6L22 (P080023/S029) | Abbott Laboratories | 2018-08-09 |