| ETI-AB-COREK Plus Assay (P990045/S026) | DiaSorin, Inc. | 2019-07-18 |
| ARCHITECT AUSAB (P050051/S035) | Abbott Laboratories, Inc. | 2019-07-03 |
| Aptima HCV Quant Dx Assay (P160023/S014) | Hologic, Inc. | 2019-06-21 |
| Aptima HCV RNA Qualitative Assay (P020011/S014) | Gen-Probe | 2019-06-21 |
| Alinity i Anti-HBc IgM Reagent Kit, Alinity i Anti-HBc IgM Calibrators, Alinity i Anti-HBc IgM Controls (P060035/S026) | Abbott Laboratories | 2019-06-20 |
| VITROS Anti-HBe (P100001/S016) | Ortho-Clinical Diagnostics | 2019-06-19 |
| VITROS Anti-HBs (P000014/S035) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S032) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS Anti-HBc IgM (P030026/S036) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS Anti-HBc (P030024/S029) | Ortho-Clinical Diagnostics | 2019-06-19 |
| VITROS HBeAg (P090028/S017) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS HBsAg (P000044/S040) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| Alinity i Anti-HCV Reagent Kit, Alinity i Anti-HCV Calibrator, Alinity i Anti-HCV Controls (P050042/S034) | Abbott Laboratories, Inc. | 2019-06-18 |
| Parvovirus B19 IgG Enzyme Immunoassay (V519IGUS) (P970054/S015) | Diasorin | 2019-06-13 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 (P060030/S077) | Roche Molecular Systems, Inc. | 2019-06-13 |
| Parvovirus B19 IgM Enzyme Immunoassay (V619IMUS) (P970055/S017) | Diasorin | 2019-06-13 |
| Cobas HCV (P150015/S030) | Roche Molecular Systems, Inc. | 2019-06-06 |
| Cobas CMV (P160041/S022) | Roche Molecular Systems, Inc. | 2019-06-06 |
| Cobas HCV (P150015/S031) | Roche Molecular Systems, Inc. | 2019-06-06 |
| Cobas HBV (P150014/S028) | Roche Molecular Systems, Inc. | 2019-06-06 |
| Cobas CMV (P160041/S021) | Roche Molecular Systems, Inc. | 2019-06-06 |
| Cobas HBV (P150014/S029) | Roche Molecular Systems, Inc. | 2019-06-06 |
| Cobas HBV Test (P150014/S026) | Roche Molecular Systems, Inc. | 2019-05-24 |
| Cobas HCV Test (P150015/S029) | Roche Molecular Systems, Inc. | 2019-05-24 |
| Cobas CMV (P160041/S020) | Roche Molecular Systems, Inc. | 2019-05-24 |
| cobas HPV Test (P100020/S047) | Roche Molecular Systems, Inc. | 2019-05-22 |
| COBAS TaqMan HBV Test for use with the High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S076) | Roche Molecular Systems, Inc. | 2019-05-22 |
| cobas HBV (P150014/S027) | Roche Molecular Systems, Inc. | 2019-05-22 |
| COBAS TaqMan HCV Test, v2.0, for use with the High Pure System and COBAS AMpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S076) | Roche Molecular Systems, Inc. | 2019-05-22 |
| cobas HCV (P150015/S028) | Roche Molecular Systems, Inc. | 2019-05-22 |
| COBAS® AmliPrep/COBAS® TaqMan® CMV Test (P110037/S047) | Roche Molecular Systems, Inc. | 2019-05-22 |
| cobas CMV (P160041/S019) | Roche Molecular Systems, Inc. | 2019-05-22 |
| Aptima HCV Quant Dx Assay (P160023/S013) | Hologic, Inc. | 2019-05-21 |
| Aptima HBV Quant Assay (P170025/S012) | Hologic, Inc. | 2019-05-21 |
| RealTime HCV (P100017/S022) | Abbott Molecular, Inc. | 2019-05-15 |
| RealTime HBV (P080026/S022) | Abbott Molecular, Inc. | 2019-05-15 |
| Abbott RealTime HCV GT II (P120012/S018) | Abbott Molecular | 2019-05-15 |
| Abbott RealTime CMV (P160044/S002) | Abbott Molecular | 2019-05-15 |
| Onclarity HPV Assay (P160037/S002) | Becton, Dickinson and Company | 2019-05-13 |
| Cobas CMV Test (P160041/S018) | Roche Molecular Systems, Inc. | 2019-05-09 |
| Cobas AmpliPrep/Cobas TaqMan HCV Test, v2.0 (P060030/S075) | Roche Molecular Systems, Inc. | 2019-05-09 |
| Cobas HPV Test (P100020/S046) | Roche Molecular Systems, Inc. | 2019-05-09 |
| Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S046) | Roche Molecular Systems, Inc. | 2019-05-09 |
| Cobas HBV Test (P150014/S025) | Roche Molecular Systems, Inc. | 2019-05-09 |
| Cobas HCV Test (P150015/S027) | Roche Molecular Systems, Inc. | 2019-05-09 |
| COBAS TaqMan HBV Test for use on the High Pure System and COBAS AMpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S075) | Roche Molecular Systems, Inc. | 2019-05-08 |
| COBAS TaqMan HCV Test, v2.0 for use on the High Pure System (P060030/S074) | Roche Molecular Systems, Inc. | 2019-05-08 |
| COBAS HCV TEST (P150015/S026) | Roche Molecular Systems, Inc. | 2019-05-08 |
| COBAS HPV TEST (P100020/S045) | Roche Molecular Systems, Inc. | 2019-05-08 |
| cobas CMV (P160041/S017) | Roche Molecular Systems, Inc. | 2019-05-03 |
| cobas HBV (P150014/S024) | Roche Molecular Systems, Inc. | 2019-05-03 |
| cobas HPV Test (P100020/S044) | Roche Molecular Systems, Inc. | 2019-05-03 |
| cobas HCV (P150015/S025) | Roche Molecular Systems, Inc. | 2019-05-03 |
| QuantiFERON- TB Gold Test and QuantiFERON- TB Gold Plus Test (P010033/S044) | Qiagen | 2019-04-29 |
| Quantiferon - TB Gold Plus Test (P010033/S045) | Qiagen | 2019-04-29 |
| APTIMA HPV 16 18/45 Genotype Assay (P120007/S020) | Gen-Probe Incorporated | 2019-04-28 |
| APTIMA HPV Assay (P100042/S022) | Gen-Probe Incorporated | 2019-04-28 |
| APTIMA HCV Quant Dx Assay (P160023/S011) | Hologic, Inc. | 2019-04-28 |
| Aptima HBV Quant Assay (P170025/S010) | Hologic, Inc. | 2019-04-28 |
| APTIMA HCV Quant Dx Assay (P160023/S012) | Hologic, Inc. | 2019-04-26 |
| APTIMA HPV 16 18/45 Genotype Assay (P120007/S021) | Gen-Probe Incorporated | 2019-04-26 |
| Aptima HBV Quant Assay (P170025/S011) | Hologic, Inc. | 2019-04-26 |
| APTIMA HPV ASSAY (P100042/S023) | Gen-Probe Incorporated | 2019-04-26 |
| APTIMA HCV RNA Qualitative Assay (P020011/S013) | Gen-Probe | 2019-04-26 |
| cobas HCV Test (P150015/S024) | Roche Molecular Systems, Inc. | 2019-04-25 |
| Elecsys Anti-HBc II (P100032/S020) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys Anti-HBc II (P100031/S026) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys Anti-HBs (P010054/S040) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys Anti-HCV Immunoassay (P090007/S020) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys HBsAg II (P160019/S009) | Roche Diagnostics, Inc. | 2019-04-24 |
| Elecsys Anti-HCV II (P140021/S016) | Roche Diagnostics Operations, Inc. | 2019-04-24 |
| Elecsys Anti-HCV Immunoassay (P090009/S018) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys Anti-HBc IgM (P110022/S027) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys Anti-HBc IgM (P110025/S023) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys Anti-HBc IgM (P110031/S024) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys HBsAg Immunoassay (P990012/S033) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys Anti-HCV Immunoassay (P090008/S021) | Roche Diagnostics Corp. | 2019-04-24 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S019) | Gen-Probe Incorporated | 2019-04-22 |
| Parvovirus B19 IgM Immunoassy (V619IMUS) (P970055/S019) | Diasorin | 2019-04-17 |
| Elecsys Anti-HBs; PreciControl Anti-HBs; Anti-HBs CalCheck (P010054/S038) | Roche Diagnostics Corp. | 2019-04-15 |
| COBAS AmpliPrep/COBAS TaqMan HBV, v2.0 (P050028/S074) | Roche Molecular Systems, Inc. | 2019-04-10 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S073) | Roche Molecular Systems, Inc. | 2019-04-10 |
| COBAS® AmpliPrep/COBAS TaqMan CV Test (P110037/S045) | Roche Molecular Systems, Inc. | 2019-04-10 |
| VERSANT HCV Genotype 2.0 Assay (LiPA) (P160016/S003) | Fujirebio Europe N.V. | 2019-04-05 |
| BD Onclarity HPV Assay, BD Viper LT System (P160037/S001) | Becton, Dickinson and Company | 2019-03-26 |
| Aptima HCV RNA Qualitative Assay (P020011/S012) | Gen-Probe | 2019-03-21 |
| Aptima HCV Quant Dx Assay (P160023/S010) | Hologic, Inc. | 2019-03-21 |
| Aptima HBV Quant Assay (P170025/S009) | Hologic, Inc. | 2019-03-21 |
| Aptima HPV Assay (P100042/S021) | Gen-Probe Incorporated | 2019-03-21 |
| TB Gold and QuantiFERON - TB Gold Plus (P010033/S043) | Qiagen | 2019-03-15 |
| cobas 4800 HPV Master Mix (P100020/S043) | Roche Molecular Systems, Inc. | 2019-03-11 |
| Atellica IM Hepatitis B e Antigen (HBeAg) Assay (P090024/S006) | Siemens Healthcare Diagnostics | 2019-03-08 |
| Atellica Im Anti-Hepatitis B core Total (HBcT) Assay (P040004/S015) | Siemens Healthcare Diagnostics | 2019-03-08 |
| Atellica IM Hepatitis B surface Antigen II (HBsII( and Atellica IM Hepatitis B surface Antigen 1 1 Comfirmatory *HBs11 C (P110041/S007) | Siemens Corp. | 2019-03-08 |
| Atellica IM Hepatitis C (aHCV) Assay (P030056/S014) | Siemens Healthcare Diagnostics | 2019-03-08 |
| Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay (P100039/S007) | Siemens Healthcare Diagnostics, Inc. | 2019-03-08 |
| Atellica IM Hepatitis B orfe IgM (aHBcM) Assay (P030040/S015) | Siemens Healthcare Diagnostics | 2019-03-08 |
| Aptima HBV Quant Assay (P170025/S008) | Hologic, Inc. | 2019-03-08 |
| Alinity i Anti-HBs Regent Kit, Alinity i Anti-HBs Calibrators, and Alinity i Anti-HBs Controls (P050051/S033) | Abbott Laboratories, Inc. | 2019-03-06 |
| Alinity i Anti-HBc Reagent Kit, Alinity i Anti-HBc Calibrator, Alinity i Anti-HBc Controls (P080023/S028) | Abbott Laboratories | 2019-03-06 |