| cobas x 480, cobas HPV Test, 240/960 Tests (P100020/S032) | Roche Molecular Systems, Inc. | 2018-08-08 |
| Aptima HCV Quant Dx Assay (P160023/S005) | Hologic, Inc. | 2018-08-07 |
| COBAS TaqMan HBV Test for use with the High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S068) | Roche Molecular Systems, Inc. | 2018-07-26 |
| Cobas HPV Test (P100020/S036) | Roche Molecular Systems, Inc. | 2018-07-26 |
| Cobas HCV (P150015/S017) | Roche Molecular Systems, Inc. | 2018-07-26 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S067) | Roche Molecular Systems, Inc. | 2018-07-26 |
| Cobas HBV (P150014/S018) | Roche Molecular Systems, Inc. | 2018-07-26 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S039) | Roche Molecular Systems, Inc. | 2018-07-26 |
| Cobas CMV (P160041/S011) | Roche Molecular Systems, Inc. | 2018-07-26 |
| ARCHITECT HBsAG Qualitative Reagent Kit (100/500 Test), ARCHITECT HBsAG Qualitative Confirmatory Reagent Kit (P110029/S027) | Abbott Laboratories | 2018-07-18 |
| Elecsys Ani-HBs, PreciControl Anti-HBs and Anti-HBs CalCheck (P010054/S037) | Roche Diagnostics Corp. | 2018-07-13 |
| Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S004) | Siemens Healthcare Diagnostics | 2018-07-12 |
| Atellica IM Anti-Hepatitis B core Total (HBcT), Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC) (P040004/S013) | Siemens Healthcare Diagnostics | 2018-07-06 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S066) | Roche Molecular Systems, Inc. | 2018-07-05 |
| cobas HPV Test (P100020/S035) | Roche Molecular Systems, Inc. | 2018-07-05 |
| cobas CMV (P160041/S010) | Roche Molecular Systems, Inc. | 2018-07-05 |
| COBAS TaqMan HBV Test for Use with the High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S067) | Roche Molecular Systems, Inc. | 2018-07-05 |
| cobas HCV (P150015/S016) | Roche Molecular Systems, Inc. | 2018-07-05 |
| cobas HBV (P150014/S017) | Roche Molecular Systems, Inc. | 2018-07-05 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S038) | Roche Molecular Systems, Inc. | 2018-07-05 |
| COBAS TaqMan HCV Test, v2.0, For use with the High Pure System, High Pure System Viral Nucleic Acid Kit (P060030/S065) | Roche Molecular Systems, Inc. | 2018-07-03 |
| cobas HBV Test (P150014/S016) | Roche Molecular Systems, Inc. | 2018-07-03 |
| cobas HCV Test (P150015/S015) | Roche Molecular Systems, Inc. | 2018-07-03 |
| COBAS TaqMan HBV Test, High Pure System Viral Nucleic Acid Kit (P050028/S066) | Roche Molecular Systems, Inc. | 2018-07-03 |
| cobas HPV Test, 240/960 Tests (P100020/S034) | Roche Molecular Systems, Inc. | 2018-07-03 |
| cobas CMV Test for use on the cobas 6800/8800 System (P160041/S009) | Roche Molecular Systems, Inc. | 2018-07-03 |
| COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test (P110037/S037) | Roche Molecular Systems, Inc. | 2018-07-03 |
| VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S032) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S015) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator (P030026/S032) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S025) | Ortho-Clinical Diagnostics | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S026) | Ortho-Clinical Diagnostics | 2018-07-02 |
| VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit (P000044/S038) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S030) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S013) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S012) | Ortho-Clinical Diagnostics | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator (P030026/S034) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit (P000044/S037) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S033) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S014) | Ortho-Clinical Diagnostics | 2018-07-02 |
| cobas HPV Test, 240 Tests (P100020/S025) | Roche Molecular Systems, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S029) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| ETI-AB-AUK PLUS Assay (P990042/S024) | DiaSorin, Inc. | 2018-06-28 |
| ETI-EBK PLUS Assay (P990043/S028) | DiaSorin, Inc. | 2018-06-28 |
| ETI-CORE-IGMK PLUS Assay (P990044/S025) | DiaSorin, Inc. | 2018-06-28 |
| ETI-AB-EBK PLUS Assay (P990041/S027) | DiaSorin, Inc. | 2018-06-28 |
| ETI-MAK-2 PLUS, HBsAg Confirmatory Test Assays (P990038/S028) | DiaSorin, Inc. | 2018-06-28 |
| ETI-AB-COREK PLUS Assay (P990045/S025) | DiaSorin, Inc. | 2018-06-28 |
| Abbott RealTime HCV Genotype II Assay (P120012/S017) | Abbott Molecular | 2018-06-21 |
| Abbott RealTime HCV Assay (P100017/S021) | Abbott Molecular, Inc. | 2018-06-21 |
| Roche CBAS TaqMan HBV Test, v2.0 (P050028/S065) | Roche Molecular Systems, Inc. | 2018-06-14 |
| Elecsys HBsAg Immunoassay (P990012/S032) | Roche Diagnostics Corp. | 2018-06-13 |
| Elecsys Anti-HCV II (P140021/S014) | Roche Diagnostics Operations, Inc. | 2018-06-13 |
| Elecsys Anti-HCV Immunoassay (P090008/S020) | Roche Diagnostics Corp. | 2018-06-13 |
| Elecsys HBcAg (P130015/S015) | Roche Diagnostics Operations, Inc. | 2018-06-13 |
| Elecsys Anti-HBc II (P100031/S024) | Roche Diagnostics Corp. | 2018-06-13 |
| Elecsys HBsAg II (P160019/S007) | Roche Diagnostics, Inc. | 2018-06-13 |
| Elecsys Anti-HBc IgM (P110022/S025) | Roche Diagnostics Corp. | 2018-06-13 |
| Elecsys Anti-HBs (P010054/S036) | Roche Diagnostics Corp. | 2018-06-13 |
| cobas HPV Test, 240/960 Tests (P100020/S033) | Roche Molecular Systems, Inc. | 2018-06-12 |
| BreathTek UBT for H.pylori Kit (BreathTek UBT Kit), Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA) (P100025/S013) | Meridian Bioscience, Inc. | 2018-06-05 |
| cobas HPV Test (P100020/S031) | Roche Molecular Systems, Inc. | 2018-06-01 |
| 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 |
| Advia Centaur HBsll (P110041/S005) | Siemens Corp. | 2018-05-23 |
| Aptima HCV Quant Dx Assay (P160023/S003) | Hologic, Inc. | 2018-05-17 |
| Aptima HBV Quant Assay (P170025/S003) | Hologic, Inc. | 2018-05-17 |
| Elecsys Anti-HBs, PreciControl Anti-HBs and Anti-HBs CalCheck (P010054/S034) | Roche Diagnostics Corp. | 2018-05-17 |
| Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S035) | Roche Molecular Systems, Inc. | 2018-05-15 |
| Cobas AmpliPrep/Cobas TaqMan HCV Test, v2.0 (P060030/S063) | Roche Molecular Systems, Inc. | 2018-05-15 |
| Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0 (P050028/S064) | Roche Molecular Systems, Inc. | 2018-05-15 |
| Cobas HPV Test (P100020/S030) | Roche Molecular Systems, Inc. | 2018-05-15 |
| Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0 (P050028/S062) | Roche Molecular Systems, Inc. | 2018-05-15 |
| Atellica IM Hepatitis C (aHCV) (P030056/S011) | Siemens Healthcare Diagnostics | 2018-05-09 |
| Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0 (P050028/S063) | Roche Molecular Systems, Inc. | 2018-05-04 |
| Cobas HCV (P150015/S014) | Roche Molecular Systems, Inc. | 2018-05-04 |
| Cobas HBV (P150014/S015) | Roche Molecular Systems, Inc. | 2018-05-04 |
| Cobas CMV (P160041/S008) | Roche Molecular Systems, Inc. | 2018-05-04 |
| Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S036) | Roche Molecular Systems, Inc. | 2018-05-04 |
| Cobas AmpliPrep/Cobas TaqMan HCV Test, v2.0 (P060030/S064) | Roche Molecular Systems, Inc. | 2018-05-04 |
| Atellica IM Hepatitis B core Antigen (aHBcM) (P030040/S012) | Siemens Healthcare Diagnostics | 2018-05-03 |
| ETI-CORE-IGMK PLUS Assay (P990044/S024) | DiaSorin, Inc. | 2018-04-24 |
| ETI-AB-AUK PLUS Assay (P990042/S023) | DiaSorin, Inc. | 2018-04-24 |
| ETI-EBK PLUS Assay (P990043/S027) | DiaSorin, Inc. | 2018-04-24 |
| ETI-AB-COREK PLUS Assay (P990045/S024) | DiaSorin, Inc. | 2018-04-24 |
| ETI-AB-EBK PLUS Assay (P990041/S026) | DiaSorin, Inc. | 2018-04-24 |
| ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays (P990038/S027) | DiaSorin, Inc. | 2018-04-24 |
| Elecsys Anti-HBc IgM (P110031/S022) | Roche Diagnostics Corp. | 2018-04-20 |
| Elecsys Anti-HBs Immunoassay (P010054/S035) | Roche Diagnostics Corp. | 2018-04-20 |
| Elecsys Anbti-HCV Immunoassay (P090007/S019) | Roche Diagnostics Corp. | 2018-04-20 |
| Elecsys Anti-HBc II (P100032/S018) | Roche Diagnostics Corp. | 2018-04-20 |
| Elecsys HBsAg Immunoassay (P990012/S031) | Roche Diagnostics Corp. | 2018-04-20 |
| Elecsys Anti-HBc II (P100031/S023) | Roche Diagnostics Corp. | 2018-04-20 |
| Elecsys Anti-HCV II (P140021/S013) | Roche Diagnostics Operations, Inc. | 2018-04-20 |
| ADVIA Centaur HBsAgII (HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control (P110041/S004) | Siemens Corp. | 2018-04-19 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S015) | Gen-Probe Incorporated | 2018-04-13 |
| Aptima HPV Assay (P100042/S017) | Gen-Probe Incorporated | 2018-04-13 |
| OraQuick HCV Rapid Antibody Test (P080027/S033) | OraSure Technologies, Inc. | 2018-04-12 |
| Aptima HCV Quant Dx Assay (P160023/S002) | Hologic, Inc. | 2018-04-10 |
| Aptima HBV Quant Assay (P170025/S002) | Hologic, Inc. | 2018-04-10 |
| artus CMV RGQ MDx Kit and artus CMV QS_RGQ MDx Kit (P130027/S005) | Qiagen, Inc. | 2018-04-06 |