| VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S011) | Ortho-Clinical Diagnostics | 2017-09-15 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS (P090028/S010) | Ortho-Clinical Diagnostics, Inc. | 2017-09-12 |
| VITROS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS (P100001/S010) | Ortho-Clinical Diagnostics | 2017-09-12 |
| OraQuick HCV Rapid Antibody Test (P080027/S029) | OraSure Technologies, Inc. | 2017-09-07 |
| Abbott Real Time HBV Amplification Reagent Kit / HBV Control Kit / HBV Calibrator Kit (P080026/S021) | Abbott Molecular, Inc. | 2017-09-01 |
| Abbott Real Time HCV Amplification Reagent Kit /HCV Control Kit /HCV Calibrator Kit (P100017/S020) | Abbott Molecular, Inc. | 2017-09-01 |
| Abbott Real Time HCV Genotype II Amplification Reagent Kit / HCV Genotype II Control Kit (P120012/S016) | Abbott Molecular | 2017-09-01 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v 2.0 (P060030/S059) | Roche Molecular Systems, Inc. | 2017-09-01 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S024) | Ortho-Clinical Diagnostics | 2017-09-01 |
| Abbott Real Time CMV Amplification Reagent Kit / CMV Control Kit / CMV Calibrator Kit. (P160044/S001) | Abbott Molecular | 2017-09-01 |
| Elecsys Anti-HBc (P100031/S019) | Roche Diagnostics Corp. | 2017-08-31 |
| Elecsys Anit-HCV (P090008/S018) | Roche Diagnostics Corp. | 2017-08-31 |
| Elecsys Anit-HBs (P010054/S031) | Roche Diagnostics Corp. | 2017-08-31 |
| Elecsys Anit-HCV (P090007/S016) | Roche Diagnostics Corp. | 2017-08-31 |
| Elecsys HBsAg II (P160019/S005) | Roche Diagnostics, Inc. | 2017-08-31 |
| Elecsys Anit-HCV II (P140021/S011) | Roche Diagnostics Operations, Inc. | 2017-08-31 |
| Elecsys HBsAg (P990012/S028) | Roche Diagnostics Corp. | 2017-08-31 |
| Elecsys Anit-HBc IgM (P110031/S019) | Roche Diagnostics Corp. | 2017-08-31 |
| Elecsys Anit-HBc IgM (P110025/S020) | Roche Diagnostics Corp. | 2017-08-31 |
| Elecsys HBeAg (P130015/S012) | Roche Diagnostics Operations, Inc. | 2017-08-31 |
| Elecsys Anit-HCV (P090009/S016) | Roche Diagnostics Corp. | 2017-08-31 |
| Elecsys Anit-HBc IgM (P110022/S023) | Roche Diagnostics Corp. | 2017-08-31 |
| Elecsys Anti-HBc (P100032/S016) | Roche Diagnostics Corp. | 2017-08-31 |
| Elecsys Anti-HBc Immunoassay test system (P100031/S017) | Roche Diagnostics Corp. | 2017-08-16 |
| Elecsys HBeAg and PreciControl HBeAg (P130015/S011) | Roche Diagnostics Operations, Inc. | 2017-08-16 |
| Elecsys Anti-HBC Immunoassay test system (P100032/S014) | Roche Diagnostics Corp. | 2017-08-16 |
| cobas HPV Test (P100020/S024) | Roche Molecular Systems, Inc. | 2017-08-15 |
| COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037/S031) | Roche Molecular Systems, Inc. | 2017-08-11 |
| COBAS TAQMAN HBV TEST (P050028/S057) | Roche Molecular Systems, Inc. | 2017-08-11 |
| COBAS HPV TEST (P100020/S023) | Roche Molecular Systems, Inc. | 2017-08-11 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S058) | Roche Molecular Systems, Inc. | 2017-08-11 |
| Elecsys Anti-HCV II Test System (P140021/S008) | Roche Diagnostics Operations, Inc. | 2017-08-10 |
| cobas HBV Test (P150014/S008) | Roche Molecular Systems, Inc. | 2017-08-09 |
| COBAS TaqMan HCV Test, v2.0, for Use with the High Pure System/COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S057) | Roche Molecular Systems, Inc. | 2017-08-09 |
| cobas HPV Test (P100020/S022) | Roche Molecular Systems, Inc. | 2017-08-09 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S030) | Roche Molecular Systems, Inc. | 2017-08-09 |
| cobas HCV Test (P150015/S007) | Roche Molecular Systems, Inc. | 2017-08-09 |
| COBAS TaqMan HBV Test for Use with the High Pure System/COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S056) | Roche Molecular Systems, Inc. | 2017-08-09 |
| cobas CMV Test (P160041/S001) | Roche Molecular Systems, Inc. | 2017-08-09 |
| digene HC2 High Risk HPV DNA Test (P890064/S034) | Qiagen Gaithersburg, Inc. | 2017-07-25 |
| OraQuick HCV Antibody Test (P080027/S028) | OraSure Technologies, Inc. | 2017-06-30 |
| VITROS Immunodiagnostic Products HBsAg Reagent Pack; VITROS Immunodiagnostic Products HBsAg Calibrator (P000044/S035) | Ortho-Clinical Diagnostics, Inc. | 2017-06-27 |
| Elecsys HBsAg II (100/200 tests) Immunoassay (P160019/S002) | Roche Diagnostics, Inc. | 2017-06-23 |
| Elecsys Anti-HCV II (100/200 tests) Immunoassay (P140021/S009) | Roche Diagnostics Operations, Inc. | 2017-06-23 |
| Elecsys Anti-HBc Immunoassay (P100031/S018) | Roche Diagnostics Corp. | 2017-06-23 |
| Elecsys Anti-HBc Immunoassay (P100032/S015) | Roche Diagnostics Corp. | 2017-06-23 |
| Elecsys HBeAg Immunoassay (P130015/S010) | Roche Diagnostics Operations, Inc. | 2017-06-23 |
| Elecsys Anti-HBs Immunoassay (P010054/S030) | Roche Diagnostics Corp. | 2017-06-23 |
| Quantiferon TB Gold (P010033/S034) | Qiagen | 2017-06-20 |
| QUANTTFERON-TB GOLD Plus (P010033/S031) | Qiagen | 2017-06-07 |
| Roche cobas HBV (P150014/S007) | Roche Molecular Systems, Inc. | 2017-06-07 |
| Roche cobas HCV (P150015/S006) | Roche Molecular Systems, Inc. | 2017-06-07 |
| ARTUS CMV RGQ MDX KIT (P130027/S002) | Qiagen, Inc. | 2017-06-02 |
| COBAS CMV (P160041) | Roche Molecular Systems, Inc. | 2017-06-01 |
| DiaSorin ETI-AB-EBK PLUS assay (P990041/S021) | DiaSorin, Inc. | 2017-05-25 |
| DiaSorin ETI-CORE-IGMK PLUS assay (P990044/S019) | DiaSorin, Inc. | 2017-05-25 |
| DiaSorin ETI-AB-COREK PLUS assay (P990045/S019) | DiaSorin, Inc. | 2017-05-25 |
| DiaSorin ETI-MAK-2 PLUS (P990038/S022) | DiaSorin, Inc. | 2017-05-25 |
| DiaSorin ETI-AB-AUK PLUS assay (P990042/S018) | DiaSorin, Inc. | 2017-05-25 |
| DiaSorin ETI-EBK PLUS assay (P990043/S022) | DiaSorin, Inc. | 2017-05-25 |
| ETI MAK-2 PLUS and HBsAg Confirmatory Test assays (P990038/S023) | DiaSorin, Inc. | 2017-05-23 |
| ETI-EBK PLUS assay (P990043/S023) | DiaSorin, Inc. | 2017-05-23 |
| ETI-AB-EBK PLUS assay (P990041/S022) | DiaSorin, Inc. | 2017-05-23 |
| ETI-AB-AUK PLUS assay (P990042/S019) | DiaSorin, Inc. | 2017-05-23 |
| ETI-CORE-IGMK PLUS assay (P990044/S020) | DiaSorin, Inc. | 2017-05-23 |
| ETI-AB-COREK PLUS assay (P990045/S020) | DiaSorin, Inc. | 2017-05-23 |
| ABBOTT REALTIME CMV (P160044) | Abbott Molecular | 2017-05-18 |
| OraQuick HCV Rapid Antibody Test (P080027/S027) | OraSure Technologies, Inc. | 2017-05-11 |
| COBAS TaqMan HCV Test v2.0, For Use With High Pure System (P060030/S056) | Roche Molecular Systems, Inc. | 2017-05-10 |
| COBAS TaqMan HBV Test, For Use With High Pure System (P050028/S055) | Roche Molecular Systems, Inc. | 2017-05-10 |
| QUANTTFERON-TB Gold (P010033/S033) | Qiagen | 2017-05-09 |
| Aptima HPV Assay (P100042/S012) | Gen-Probe Incorporated | 2017-05-04 |
| Aptima HPV 16 18/45 Genotype Assay. (P120007/S010) | Gen-Probe Incorporated | 2017-05-04 |
| ADVIA Centaur HBeAg (P090024/S003) | Siemens Healthcare Diagnostics | 2017-04-25 |
| BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0 (P100025/S012) | Meridian Bioscience, Inc. | 2017-03-30 |
| VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA) (P160016) | Fujirebio Europe N.V. | 2017-03-14 |
| Parvovirus B19 IgM Enzyme Immunoassay (P970055/S015) | Diasorin | 2017-03-09 |
| Parvovirus B19 IgG Enzyme Immunoassay (P970054/S013) | Diasorin | 2017-03-09 |
| QuantiFERON-TB GOLD Test (P010033/S032) | Qiagen | 2017-03-07 |
| Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM (P110025/S017) | Roche Diagnostics Corp. | 2017-03-03 |
| Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM (P110031/S016) | Roche Diagnostics Corp. | 2017-03-03 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S026) | OraSure Technologies, Inc. | 2017-02-28 |
| APTIMA HCV QUANT DX ASSAY (P160023) | Hologic, Inc. | 2017-02-13 |
| PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (V5191GUS) (P970054/S012) | Diasorin | 2017-01-19 |
| PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (V619IMUS) (P970055/S014) | Diasorin | 2017-01-19 |
| ELECSYS HBEAG AND PRECICONTROL HBEAG (P130015/S009) | Roche Diagnostics Operations, Inc. | 2017-01-13 |
| BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0 (P100025/S011) | Meridian Bioscience, Inc. | 2017-01-04 |
| ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS (P030040/S011) | Siemens Healthcare Diagnostics | 2016-12-25 |
| Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II (P160019) | Roche Diagnostics, Inc. | 2016-12-23 |
| ABBOTT REALTIME HCV (P100017/S019) | Abbott Molecular, Inc. | 2016-12-23 |
| ABBOTT REALTIME HBV ASSAY (P080026/S020) | Abbott Molecular, Inc. | 2016-12-23 |
| ABBOTT REALTIME HCV GENOTYPE II (P120012/S015) | Abbott Molecular | 2016-12-23 |
| COBAS HCV (P150015/S005) | Roche Molecular Systems, Inc. | 2016-12-19 |
| COBAS HBV (P150014/S006) | Roche Molecular Systems, Inc. | 2016-12-19 |
| OraQuick HCV Rapid Antibody Test (P080027/S025) | OraSure Technologies, Inc. | 2016-12-15 |
| ABBOTT REALTIME HBV ASSAY/ CALIBRATOR KIT/CONTROL KIT & ABBOTT MSAMPLE PREPARATION SYSTEM DNA (P080026/S019) | Abbott Molecular, Inc. | 2016-12-13 |
| ABBOTT ARCHITECT AUSAB (P050051/S032) | Abbott Laboratories, Inc. | 2016-12-09 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S028) | Ortho-Clinical Diagnostics, Inc. | 2016-11-30 |
| ABBOTT REALTIME HBV ASSAY, CALIBRATOR KIT, CONTROL KIT; ABBOTT MSAMPLE PREPARATION SYSTEMDNA. (P080026/S018) | Abbott Molecular, Inc. | 2016-11-22 |
| ELECSYS HBSAG (P990012/S027) | Roche Diagnostics Corp. | 2016-11-22 |