| QuantiFERON-TB Gold and QuantiFERON-TB Gold Plus (P010033/S039) | Qiagen | 2018-03-27 |
| HC2 High-Risk HPV DNA Test and digene / HC2 HPV DNA Test (P890064/S040) | Qiagen Gaithersburg, Inc. | 2018-03-27 |
| Cobas HPV Test (P100020/S029) | Roche Molecular Systems, Inc. | 2018-03-26 |
| Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S034) | Roche Molecular Systems, Inc. | 2018-03-26 |
| Cobas CMV Test (P160041/S007) | Roche Molecular Systems, Inc. | 2018-03-26 |
| Cobas AmpliPrep/Cobas TaqMan HCV Test, v.20 (P060030/S062) | Roche Molecular Systems, Inc. | 2018-03-26 |
| Cobas TaqMan HBV Test, Cobas AmpliPep/Cobas, TaqMan HBV Test, v2.0, Cobas AmpliPrep (P050028/S061) | Roche Molecular Systems, Inc. | 2018-03-26 |
| Cobas HBV Test (P150014/S014) | Roche Molecular Systems, Inc. | 2018-03-26 |
| Cobas HCV Test (P150015/S013) | Roche Molecular Systems, Inc. | 2018-03-26 |
| digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test (P890064/S039) | Qiagen Gaithersburg, Inc. | 2018-03-16 |
| Cobas CMV (P160041/S006) | Roche Molecular Systems, Inc. | 2018-03-16 |
| ETI-AB-EBK PLUS Assay (P990041/S024) | DiaSorin, Inc. | 2018-03-14 |
| ETI-AB-AUK PLUS Assay (P990042/S021) | DiaSorin, Inc. | 2018-03-14 |
| ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays (P990038/S025) | DiaSorin, Inc. | 2018-03-14 |
| ETI-EBK PLUS Assay (P990043/S025) | DiaSorin, Inc. | 2018-03-14 |
| ETI-CORE-IGMK PLUS Assay (P990044/S022) | DiaSorin, Inc. | 2018-03-14 |
| ETI-AB-COREK PLUS Assay (P990045/S022) | DiaSorin, Inc. | 2018-03-14 |
| digene HC2 High-Risk HPB DNA Test and digene HC2 HPV DNA Test (P890064/S038) | Qiagen Gaithersburg, Inc. | 2018-03-14 |
| artus CMV RGQ MDx Kit and artus CMV QS-RGQ MDx Kit (P130027/S004) | Qiagen, Inc. | 2018-03-13 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S014) | Gen-Probe Incorporated | 2018-03-08 |
| Aptima HPV Assay (P100042/S016) | Gen-Probe Incorporated | 2018-03-08 |
| Elecsys HBeAg and PreciControl HBeAg (P130015/S013) | Roche Diagnostics Operations, Inc. | 2018-03-02 |
| Aptima HPV Assay (P100042/S013) | Gen-Probe Incorporated | 2018-02-28 |
| Aptima HCV Quant Dx Assay (P160023/S001) | Hologic, Inc. | 2018-02-23 |
| VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator (P030026/S033) | Ortho-Clinical Diagnostics, Inc. | 2018-02-23 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S011) | Gen-Probe Incorporated | 2018-02-23 |
| QuantiFeron TB Gold and QuantiFeron TB Gold Plus (P010033/S038) | Qiagen | 2018-02-23 |
| digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test (P890064/S037) | Qiagen Gaithersburg, Inc. | 2018-02-21 |
| Cobas HCV Test (P150015/S012) | Roche Molecular Systems, Inc. | 2018-02-20 |
| Cobas HBV Test (P150014/S013) | Roche Molecular Systems, Inc. | 2018-02-20 |
| Cobas CMV Test (P160041/S005) | Roche Molecular Systems, Inc. | 2018-02-20 |
| HBeAg Reagent Pack and Calibrator (P090028/S014) | Ortho-Clinical Diagnostics, Inc. | 2018-02-16 |
| Vitros Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S013) | Ortho-Clinical Diagnostics | 2018-02-16 |
| BD ONCLARITY HPV ASSAY (P160037) | Becton, Dickinson and Company | 2018-02-12 |
| Elecsys Anti-HBc II, PreciControl Anti-HBc (P100031/S020) | Roche Diagnostics Corp. | 2018-02-09 |
| digene Hybird Capture 2 (HC2) HPV DNA Test (P890064/S036) | Qiagen Gaithersburg, Inc. | 2018-02-08 |
| VERSANT HCV Genotype 2.0 Assay (LiPA) (P160016/S001) | Fujirebio Europe N.V. | 2018-02-08 |
| OraQuick HCV Rapid Antibody Test (P080027/S032) | OraSure Technologies, Inc. | 2018-02-01 |
| Aptima HBV Quant Assay (P170025) | Hologic, Inc. | 2018-01-23 |
| Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II (P160019/S003) | Roche Diagnostics, Inc. | 2018-01-18 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S013) | Gen-Probe Incorporated | 2018-01-18 |
| Aptima HPV Assay (P100042/S015) | Gen-Probe Incorporated | 2018-01-18 |
| OraQuick HCV Rapid Antibody Test (P080027/S031) | OraSure Technologies, Inc. | 2018-01-03 |
| Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II (P160019/S004) | Roche Diagnostics, Inc. | 2017-12-29 |
| Cobas 4800 Wash and Lysis Reagents (P100020/S028) | Roche Molecular Systems, Inc. | 2017-12-26 |
| Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110022/S022) | Roche Diagnostics Corp. | 2017-12-21 |
| Digene HC2 HPV DNA Test / Digene HC2 High Risk HPV DNA Test (P890064/S035) | Qiagen Gaithersburg, Inc. | 2017-12-21 |
| Elecsys HBeAg (P130015/S014) | Roche Diagnostics Operations, Inc. | 2017-12-20 |
| Cobas TaqMan HBV Test v2.0 (P050028/S060) | Roche Molecular Systems, Inc. | 2017-12-20 |
| Elecsys HBsAg II (P160019/S006) | Roche Diagnostics, Inc. | 2017-12-20 |
| Elecsys Anti-HCV Immunoassay (P090009/S017) | Roche Diagnostics Corp. | 2017-12-20 |
| Cobas TaqMan HCV Test, v2.0 (P060030/S061) | Roche Molecular Systems, Inc. | 2017-12-20 |
| Elecsys Anti-HCV Immunoassay (P090008/S019) | Roche Diagnostics Corp. | 2017-12-20 |
| Elecsys Anti-HBs (P010054/S032) | Roche Diagnostics Corp. | 2017-12-20 |
| Elecsys HBsAg Immunoassay (P990012/S029) | Roche Diagnostics Corp. | 2017-12-20 |
| Elecsys Anti-HBc II (P100032/S017) | Roche Diagnostics Corp. | 2017-12-20 |
| Elecsys Anti-HBc IgM (P110022/S024) | Roche Diagnostics Corp. | 2017-12-20 |
| Elecsys Anti-HBc IgM (P110025/S021) | Roche Diagnostics Corp. | 2017-12-20 |
| Elecsys Anti-HCV Immunoassay (P090007/S017) | Roche Diagnostics Corp. | 2017-12-20 |
| Elecsys Anti-HBc II (P100031/S021) | Roche Diagnostics Corp. | 2017-12-20 |
| Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S033) | Roche Molecular Systems, Inc. | 2017-12-20 |
| Elecsys Anti-HBc IgM (P110031/S020) | Roche Diagnostics Corp. | 2017-12-20 |
| Elecsys Anti-HCV II (P140021/S012) | Roche Diagnostics Operations, Inc. | 2017-12-20 |
| Cobas HCV (P150015/S011) | Roche Molecular Systems, Inc. | 2017-12-11 |
| Cobas CMV (P160041/S004) | Roche Molecular Systems, Inc. | 2017-12-11 |
| Cobas HBV (P150014/S012) | Roche Molecular Systems, Inc. | 2017-12-11 |
| QuantiFERON-TB Gold and QuantiFERON -TB Gold Plus. (P010033/S036) | Qiagen | 2017-12-07 |
| QuantiFERON - TB Gold Test and TB Gold Plus Test (P010033/S035) | Qiagen | 2017-11-21 |
| Artus CMV RGQ and QS-RGQ MDx Kit (P130027/S003) | Qiagen, Inc. | 2017-11-15 |
| Cobas HCV (P150015/S010) | Roche Molecular Systems, Inc. | 2017-11-13 |
| Cobas HPV Test (P100020/S027) | Roche Molecular Systems, Inc. | 2017-11-13 |
| Cobas HBV (P150014/S011) | Roche Molecular Systems, Inc. | 2017-11-13 |
| Roche Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0 (P050028/S059) | Roche Molecular Systems, Inc. | 2017-11-13 |
| Cobas CMV (P160041/S003) | Roche Molecular Systems, Inc. | 2017-11-13 |
| Vitros Immunodiagnostic Products HBs Ag Reagent Pack and Calibrator (P000044/S036) | Ortho-Clinical Diagnostics, Inc. | 2017-11-09 |
| Aptima HPV Assay (P100042/S014) | Gen-Probe Incorporated | 2017-11-03 |
| Aptima HCV RNA Qualitative Assay (P020011/S010) | Gen-Probe | 2017-11-03 |
| Elecsys Anti-HCV II, PreciControl Anti-HCV (P140021/S010) | Roche Diagnostics Operations, Inc. | 2017-11-03 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S012) | Gen-Probe Incorporated | 2017-11-03 |
| Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II (P160019/S001) | Roche Diagnostics, Inc. | 2017-11-01 |
| cobas HCV Test (P150015/S009) | Roche Molecular Systems, Inc. | 2017-10-26 |
| cobas HBV Test (P150014/S010) | Roche Molecular Systems, Inc. | 2017-10-26 |
| VITROS Immunodiagnostic Products HBeAg Reagent Pack / VITROS Immunodiagnostic Products HBeAg Calibrator (P090028/S011) | Ortho-Clinical Diagnostics, Inc. | 2017-10-26 |
| Roche cobas HPV Test (P100020/S026) | Roche Molecular Systems, Inc. | 2017-10-23 |
| ETI-AB-EBK PLUS assay (P990041/S023) | DiaSorin, Inc. | 2017-10-16 |
| ETI-AB-AUK PLUS assay (P990042/S020) | DiaSorin, Inc. | 2017-10-16 |
| ETI-AB-COREK PLUS assay (P990045/S021) | DiaSorin, Inc. | 2017-10-16 |
| ETI-EBK PLUS assay (P990043/S024) | DiaSorin, Inc. | 2017-10-16 |
| ETI MAK-2 PLUS and HBsAg Confirmatory Test assays (P990038/S024) | DiaSorin, Inc. | 2017-10-16 |
| ETI-CORE-IGMK PLUS assay (P990044/S021) | DiaSorin, Inc. | 2017-10-16 |
| COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test (P110037/S032) | Roche Molecular Systems, Inc. | 2017-10-13 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S060) | Roche Molecular Systems, Inc. | 2017-10-13 |
| COBAS TaqMan HBV Test / High Pure System Viral Nucleic Acid Kit (P050028/S058) | Roche Molecular Systems, Inc. | 2017-10-13 |
| cobas CMV test for use on the cobas 6800/8800 System (P160041/S002) | Roche Molecular Systems, Inc. | 2017-10-13 |
| cobas HBV Test (P150014/S009) | Roche Molecular Systems, Inc. | 2017-10-13 |
| Cobas HCV Test (P150015/S008) | Roche Molecular Systems, Inc. | 2017-10-13 |
| ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS (P110029/S026) | Abbott Laboratories | 2017-09-27 |
| OraQuick HCV Rapid Antibody Test (P080027/S030) | OraSure Technologies, Inc. | 2017-09-27 |
| ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM (P150042) | Zeus Scientific, Inc. | 2017-09-19 |
| ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM (P150045) | Zeus Scientific, Inc. | 2017-09-19 |