| LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus (P180047/S001) | DiaSorin, Inc. | 2020-10-26 |
| VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S036) | Ortho-Clinical Diagnostics, Inc. | 2020-10-22 |
| Elecsys HBsAg II Auto Confirm (P160019/S011) | Roche Diagnostics, Inc. | 2020-10-19 |
| OraQuick HCV Rapid Antibody Test (P080027/S037) | OraSure Technologies, Inc. | 2020-10-16 |
| BD Onclarity HPV Assay (P160037/S009) | Becton, Dickinson and Company | 2020-10-13 |
| cobas HPV (P190028/S003) | Roche Molecular Systems, Inc. | 2020-10-07 |
| cobas HBV (P150014/S039) | Roche Molecular Systems, Inc. | 2020-10-07 |
| cobas CMV (P160041/S031) | Roche Molecular Systems, Inc. | 2020-10-07 |
| cobas HCV (P150015/S041) | Roche Molecular Systems, Inc. | 2020-10-07 |
| VERSANT HCV Genotype 2.0 Assay (LiPA) (P160016/S005) | Fujirebio Europe N.V. | 2020-09-23 |
| IMMULITE 2000 HBsAg Confirmatory (P010050/S018) | Siemens Healthcare Diagnostics Products, Ltd. | 2020-09-08 |
| IMMULITE 2000 Anti-HBcM (P010053/S012) | Siemens Healthcare Diagnostics Products, Ltd. | 2020-09-08 |
| IMMULITE 2000 Anti-HBs (P010052/S014) | Siemens Healthcare Diagnostics Products, Ltd. | 2020-09-08 |
| IMMULITE 2000 Anti-HBc (P010051/S013) | Siemens Healthcare Diagnostics Products, Ltd. | 2020-09-08 |
| LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg (P180048) | DiaSorin, Inc. | 2020-08-29 |
| LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM (P180045) | DiaSorin, Inc. | 2020-08-29 |
| LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe (P180049) | DiaSorin, Inc. | 2020-08-29 |
| LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test (P190017) | DiaSorin, Inc. | 2020-08-29 |
| Alinity m HBV (P200013) | Abbott Molecular, Inc. | 2020-08-29 |
| ARCHITECT Anti-HCV, Alinity i Anti-HCV (P050042/S044) | Abbott Laboratories, Inc. | 2020-08-28 |
| VERSANT HCV Genotype 2.0 Assay (LiPA) (P160016/S006) | Fujirebio Europe N.V. | 2020-08-27 |
| cobas 4800 HPV Test (P100020/S053) | Roche Molecular Systems, Inc. | 2020-08-26 |
| cobas HBV (P150014/S038) | Roche Molecular Systems, Inc. | 2020-08-26 |
| cobas HCV (P150015/S040) | Roche Molecular Systems, Inc. | 2020-08-26 |
| Roche COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S083) | Roche Molecular Systems, Inc. | 2020-08-26 |
| cobas HPV Test (P190028/S002) | Roche Molecular Systems, Inc. | 2020-08-26 |
| cobas CMV (P160041/S030) | Roche Molecular Systems, Inc. | 2020-08-26 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S084) | Roche Molecular Systems, Inc. | 2020-08-26 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S054) | Roche Molecular Systems, Inc. | 2020-08-26 |
| ADVIA Centaur aHBs2 Readypack Reagents and Quality Control Materials (P100039/S010) | Siemens Healthcare Diagnostics, Inc. | 2020-08-25 |
| ADVIA Centaur HBeAg Readypack Reagents and Quality Control Material (P090024/S009) | Siemens Healthcare Diagnostics | 2020-08-25 |
| ADVIA Centaur HBsAgII/Confirmatory Readypack Reagents and QC Material (P110041/S010) | Siemens Corp. | 2020-08-25 |
| ADVIA Centaur HBsAg/Confirmatory Readypack Reagents, Calibrators and Controls (P030049/S015) | Siemens Healthcare Diagnostics | 2020-08-25 |
| ADVIA Centaur HBc Total Readypack Reagents and Quality COntrol Materials (P040004/S018) | Siemens Healthcare Diagnostics | 2020-08-25 |
| ADVIA CENTAUR HCV ReadyPack Reagents and Quality Control Materials (P030056/S018) | Siemens Healthcare Diagnostics | 2020-08-25 |
| ADVIA Centaur HBc IgM Readypack Reagents and Quality Control Material (P030040/S018) | Siemens Healthcare Diagnostics | 2020-08-25 |
| ETI-AB-EBK PLUS assay (P990041/S030) | DiaSorin, Inc. | 2020-08-13 |
| LIAISON QuantiFERON - TB Gold Plus and LIAISON Control QuantiFERON - TB Gold Plus (P180047/S005) | DiaSorin, Inc. | 2020-08-13 |
| Parvovirus B19 IgM Enzyme Immunoassay (P970055/S021) | Diasorin | 2020-08-13 |
| LIAISON XL Murex Anti-HBs, LIAISON XL Murex Control Anti-HBs and LIAISON XL Murex Anti-HBs Verifiers (P180039/S002) | DiaSorin, Inc. | 2020-08-13 |
| Parvovirus B19 IgG Enzyme Immunoassay (P970054/S019) | Diasorin | 2020-08-13 |
| ETI-AB-COREK PLUS assay (P990045/S028) | DiaSorin, Inc. | 2020-08-13 |
| LIAISON XL Murex Anti-HBc and LIAISON XL Murex Control Anti-HBc (P180038/S003) | DiaSorin, Inc. | 2020-08-13 |
| ETI-CORE-IGMK PLUS assay (P990044/S028) | DiaSorin, Inc. | 2020-08-13 |
| ETI-MAK-2 PLUS and HBsAg Confirmatory Test assays (P990038/S031) | DiaSorin, Inc. | 2020-08-13 |
| ETI-EBK PLUS assay (P990043/S031) | DiaSorin, Inc. | 2020-08-13 |
| ETI-AB-AUK PLUS assay (P990042/S027) | DiaSorin, Inc. | 2020-08-13 |
| T SPOT-TB Test (P070006/S014) | Oxford Immunotec, Ltd. | 2020-08-11 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S033) | Ortho-Clinical Diagnostics, Inc. | 2020-08-07 |
| LIAISON XL MUREX Anti-HBc (P180038/S002) | DiaSorin, Inc. | 2020-08-06 |
| LIAISON XL MUREX Anti-HBs (P180039/S001) | DiaSorin, Inc. | 2020-08-06 |
| LIAISON QuantiFERON - TB Gold Plus (P180047/S004) | DiaSorin, Inc. | 2020-08-06 |
| LIAISON XL MUREX HCV Ab (P190011/S002) | DiaSorin, Inc. | 2020-08-06 |
| BD Onclarity HPV Assay (P160037/S007) | Becton, Dickinson and Company | 2020-08-03 |
| ARCHITECT HBsAg Qualitative Reagent Kit, ARCHITECT HBsAg Qualitative Reagent Kit, ARCHITECT HBsAg Qualitative Confirmato (P110029/S033) | Abbott Laboratories | 2020-07-30 |
| LIAISON QuantiFERON TB Gold Plus (P180047/S003) | DiaSorin, Inc. | 2020-07-23 |
| Aptima HBV Quant Assay (P170025/S016) | Hologic, Inc. | 2020-07-21 |
| Aptima HPV Assay (P100042/S031) | Gen-Probe Incorporated | 2020-07-21 |
| Aptima HCV Quant Dx Assay (P160023/S019) | Hologic, Inc. | 2020-07-21 |
| Aptima HCV RNA Qualitative Assay (P020011/S016) | Gen-Probe | 2020-07-21 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S028) | Gen-Probe Incorporated | 2020-07-21 |
| cobas HPV Mg/Mn (P100020/S052) | Roche Molecular Systems, Inc. | 2020-06-24 |
| ADVIA Centaur HCV, and Atellica HCV (P030056/S017) | Siemens Healthcare Diagnostics | 2020-06-21 |
| digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test (P890064/S041) | Qiagen Gaithersburg, Inc. | 2020-06-18 |
| BD Onclarity HPV Assay (P160037/S004) | Becton, Dickinson and Company | 2020-06-12 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S027) | Gen-Probe Incorporated | 2020-06-11 |
| Aptima HPV Assay (P100042/S030) | Gen-Probe Incorporated | 2020-06-11 |
| Alinity m HCV (P190025/S002) | Abbott Molecular, Inc. | 2020-06-09 |
| Alinity i HBsAg Qualitative II Reagent Kit and Alinity i HBsAg Qualitative II Confirmatory Kit (P110029/S030) | Abbott Laboratories | 2020-06-05 |
| Alinity i Anti-HCV Reagent Kit (P050042/S040) | Abbott Laboratories, Inc. | 2020-06-05 |
| Alinity i Anti-HBc IgM Reagent Kit (P060035/S028) | Abbott Laboratories | 2020-06-05 |
| Alinity i Anti-HBc Reagent Kit (P080023/S031) | Abbott Laboratories | 2020-06-05 |
| Alinity i Anti-HBs Reagent Kit (P050051/S037) | Abbott Laboratories, Inc. | 2020-06-05 |
| BreathTek UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA) (P100025/S014) | Meridian Bioscience, Inc. | 2020-05-26 |
| Alinity i Anti-HBc lgM (P060035/S029) | Abbott Laboratories | 2020-05-23 |
| ARCHITECT Anti-HCV (P050042/S042) | Abbott Laboratories, Inc. | 2020-05-23 |
| ARCHITECT CORE-M (P060035/S030) | Abbott Laboratories | 2020-05-23 |
| Alinity i Anti-HBc (P080023/S032) | Abbott Laboratories | 2020-05-23 |
| Alinity i Anti-HCV (P050042/S041) | Abbott Laboratories, Inc. | 2020-05-23 |
| ARCHITECT HBsAg Qualitative/Confirmatory (P110029/S032) | Abbott Laboratories | 2020-05-23 |
| Alinity i Anti-HBs (P050051/S038) | Abbott Laboratories, Inc. | 2020-05-23 |
| ARCHITECT CORE (P080023/S033) | Abbott Laboratories | 2020-05-23 |
| ARCHITECT AUSAB (P050051/S039) | Abbott Laboratories, Inc. | 2020-05-23 |
| Alinity i HBsAg Qualitative II (P110029/S031) | Abbott Laboratories | 2020-05-23 |
| cobas HPV Test (P100020/S051) | Roche Molecular Systems, Inc. | 2020-05-14 |
| cobas HBV (P150014/S036) | Roche Molecular Systems, Inc. | 2020-05-14 |
| COBAS® TaqMan® HBV Test for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0 (P050028/S082) | Roche Molecular Systems, Inc. | 2020-05-14 |
| COBAS® TaqMan® HCV Test, v2.0, for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test, v2.0 (P060030/S083) | Roche Molecular Systems, Inc. | 2020-05-14 |
| cobas HCV (P150015/S038) | Roche Molecular Systems, Inc. | 2020-05-14 |
| cobas CMV (P160041/S029) | Roche Molecular Systems, Inc. | 2020-05-14 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S053) | Roche Molecular Systems, Inc. | 2020-05-14 |
| Alinity m HCV (P190025/S001) | Abbott Molecular, Inc. | 2020-05-06 |
| cobas HPV (P190028/S001) | Roche Molecular Systems, Inc. | 2020-05-05 |
| ARCHITECT Anti-HCV and Alinity i Anti-HCV (P050042/S043) | Abbott Laboratories, Inc. | 2020-04-29 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S025) | Gen-Probe Incorporated | 2020-04-27 |
| Aptima HPV Assay (P100042/S027) | Gen-Probe Incorporated | 2020-04-27 |
| Parvovirus B19 IgG Enzyme Immunoassay (P970054/S018) | Diasorin | 2020-04-21 |
| Parvovirus B19 IgM Enzyme Immunoassay (P970055/S020) | Diasorin | 2020-04-21 |
| LIAISON XL MUREX HCV Ab (P190011/S001) | DiaSorin, Inc. | 2020-04-08 |
| LIAISON XL MUREX anti-HBc (P180038/S001) | DiaSorin, Inc. | 2020-04-08 |