| ARCHITECT AUSAB (P050051/S021) | Abbott Laboratories, Inc. | 2013-07-18 |
| ARCHITECT HBSAG/HBSAG CONFIRMATORY (P060007/S027) | Abbott Laboratories | 2013-07-18 |
| APTIMA HPV ASSAY (P100042/S001) | Gen-Probe Incorporated | 2013-07-15 |
| ETI-CORE-IGMK PLUS (P990044/S015) | DiaSorin, Inc. | 2013-06-25 |
| ETI-AB-EBK PLUS ASSAY (P990041/S017) | DiaSorin, Inc. | 2013-06-25 |
| ETI-MAK-2 PLUS ASSAY (P990038/S018) | DiaSorin, Inc. | 2013-06-25 |
| ROCHE COBAS HPV TEST (P100020/S004) | Roche Molecular Systems, Inc. | 2013-06-25 |
| ETI-AB-AUK PLUS ASSAY (P990042/S014) | DiaSorin, Inc. | 2013-06-25 |
| ETI-EBK PLUS ASSAY (P990043/S018) | DiaSorin, Inc. | 2013-06-25 |
| ETI-AB-COREK PLUS (P990045/S015) | DiaSorin, Inc. | 2013-06-25 |
| COBAS TAQMAN HBV FOR USE WITH THE HIGH PURE SYSTEM (P050028/S033) | Roche Molecular Systems, Inc. | 2013-06-24 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0 (P000012/S043) | Roche Molecular Systems, Inc. | 2013-06-24 |
| ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) (P120012) | Abbott Molecular | 2013-06-20 |
| T-SPOT .TB TEST (P070006/S009) | Oxford Immunotec, Ltd. | 2013-06-12 |
| COBAS AMPLICOR HCV TEST V2.0,COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S042) | Roche Molecular Systems, Inc. | 2013-06-07 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST,V2.0 (P050028/S032) | Roche Molecular Systems, Inc. | 2013-06-06 |
| COBAS AMPLIPREP/COBRA TAQMAN CMV TEST (P110037/S006) | Roche Molecular Systems, Inc. | 2013-06-06 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0 (P000012/S041) | Roche Molecular Systems, Inc. | 2013-06-06 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0 (P060030/S032) | Roche Molecular Systems, Inc. | 2013-06-06 |
| BREATH TEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR (P100025/S004) | Meridian Bioscience, Inc. | 2013-05-29 |
| ABBOTT REALTIME HBV (P080026/S007) | Abbott Molecular, Inc. | 2013-05-28 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S011) | OraSure Technologies, Inc. | 2013-05-28 |
| ABBOTT REALTIME HCV (P100017/S006) | Abbott Molecular, Inc. | 2013-05-28 |
| BREATH TEK UBT FOR H PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION(PUHR-CA) (P100025/S002) | Meridian Bioscience, Inc. | 2013-05-23 |
| ARCHITECT ANTI-HCV (P050042/S024) | Abbott Laboratories, Inc. | 2013-05-22 |
| ELECSCYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG, ELECSYS HBSAG CONFIRMATORY TEST (P990012/S016) | Roche Diagnostics Corp. | 2013-05-14 |
| CCOBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S031) | Roche Molecular Systems, Inc. | 2013-05-07 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 (P050028/S030) | Roche Molecular Systems, Inc. | 2013-05-03 |
| CERVISTA HPV HR, GENFIND DNA EXTRACTION KIT (P080014/S015) | Hologic, Inc. | 2013-04-18 |
| VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY (P020011/S007) | Gen-Probe | 2013-04-08 |
| COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST (P110037/S005) | Roche Molecular Systems, Inc. | 2013-03-21 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S009) | OraSure Technologies, Inc. | 2013-03-21 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S010) | OraSure Technologies, Inc. | 2013-03-19 |
| CERVISTA HPV HR ASSAY (P080014/S016) | Hologic, Inc. | 2013-03-15 |
| ARCHITECT CORE-M (P060035/S020) | Abbott Laboratories | 2013-03-13 |
| ARCHITECT CORE-M (P060035/S019) | Abbott Laboratories | 2013-03-13 |
| ARCHITECT CORE (P080023/S020) | Abbott Laboratories | 2013-03-13 |
| ARCHITECT CORE (P080023/S021) | Abbott Laboratories | 2013-03-13 |
| ARCHITECT HBSAG/CONFIRMATORY (P060007/S026) | Abbott Laboratories | 2013-03-13 |
| ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY (P110029/S011) | Abbott Laboratories | 2013-03-13 |
| ARCHITECT AUSAB (P050051/S020) | Abbott Laboratories, Inc. | 2013-03-13 |
| ARCHITECT ANTI-HCV (P050042/S023) | Abbott Laboratories, Inc. | 2013-03-13 |
| ARCHITECT ANTI-HCV (P050042/S022) | Abbott Laboratories, Inc. | 2013-03-13 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK (P010021/S024) | Ortho-Clinical Diagnostics, Inc. | 2013-03-05 |
| ABBOTT REALTIME HCV (P100017/S004) | Abbott Molecular, Inc. | 2013-03-01 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 (P060030/S027) | Roche Molecular Systems, Inc. | 2013-02-14 |
| COBAS AMPLIPREP / COBAS TAQMAN HCV TEST (P060030/S031) | Roche Molecular Systems, Inc. | 2013-02-11 |
| COBAS AMPLIPREP / COBAS TAQMAN CMV TEST (P110037/S004) | Roche Molecular Systems, Inc. | 2013-02-11 |
| COBAS AMPLIPREP / COBAS TAQMAN HBV TEST, V2.0 (P050028/S029) | Roche Molecular Systems, Inc. | 2013-02-11 |
| ABBOTT REALTIME HBV (P080026/S005) | Abbott Molecular, Inc. | 2013-02-07 |
| CERVISTA HPV HR COMPONENTS (P080014/S011) | Hologic, Inc. | 2013-02-04 |
| CERVISTA HPV 16/18 COMPONENTS (P080015/S006) | Hologic, Inc. | 2013-02-04 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S008) | OraSure Technologies, Inc. | 2013-01-24 |
| ARCHITECT I1000 SYSTEM (P110029/S001) | Abbott Laboratories | 2013-01-10 |
| APTIMA HCV RNA QUALITATIVE ASSAY (P020011/S006) | Gen-Probe | 2013-01-09 |
| COBAS AMPLIPREP / COBAS TAQMAN CMV TEST, V2.0 (P110037/S003) | Roche Molecular Systems, Inc. | 2013-01-07 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S028) | Roche Molecular Systems, Inc. | 2013-01-02 |
| COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/BOBAS TAQMAN HCV TEST (P060030/S030) | Roche Molecular Systems, Inc. | 2013-01-02 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM (P030026/S027) | Ortho-Clinical Diagnostics, Inc. | 2012-12-21 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ABEAG (P090028/S006) | Ortho-Clinical Diagnostics, Inc. | 2012-12-21 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE (P100001/S005) | Ortho-Clinical Diagnostics | 2012-12-21 |
| ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 601) AND PRECICONTROL ANTI-HCV (P090008/S012) | Roche Diagnostics Corp. | 2012-12-20 |
| ELECSYS ANTI-HCV ON COBAS E 411 (P090007/S007) | Roche Diagnostics Corp. | 2012-12-20 |
| ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170 (P100031/S005) | Roche Diagnostics Corp. | 2012-12-20 |
| ELECSYS HBSAG (P990012/S013) | Roche Diagnostics Corp. | 2012-12-20 |
| PRECICONTROL ANTI-HBC (ELECSYS) 2010 (P100032/S008) | Roche Diagnostics Corp. | 2012-12-20 |
| PRECICONTROL HBSAG (P990012/S019) | Roche Diagnostics Corp. | 2012-12-20 |
| ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 411) AND PRECICONTROL ANTI-HCV (P090007/S011) | Roche Diagnostics Corp. | 2012-12-20 |
| ELECSYS ANTI-HCV ON COBAS E 601 (P090008/S008) | Roche Diagnostics Corp. | 2012-12-20 |
| ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170 (P090009/S007) | Roche Diagnostics Corp. | 2012-12-20 |
| ELECSYS ANTI-HBC ON ELECSYS 2010 (P100032/S005) | Roche Diagnostics Corp. | 2012-12-20 |
| ELECSYS ANTI-HBS (P010054/S018) | Roche Diagnostics Corp. | 2012-12-20 |
| PRECICONTROL ANTI-HBS (P010054/S021) | Roche Diagnostics Corp. | 2012-12-20 |
| PRECICONTROL ANTI-HBC (MODULAR ANALYTICS E170) (P100031/S010) | Roche Diagnostics Corp. | 2012-12-20 |
| ELECSYS ANTI-HCV IMMUNOASSAY (MODULAR ANALYTICS E170) AND PRECICONTROL ANTI-HCV (P090009/S011) | Roche Diagnostics Corp. | 2012-12-20 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S007) | OraSure Technologies, Inc. | 2012-12-17 |
| ARCHITECT AUSAB (P050051/S019) | Abbott Laboratories, Inc. | 2012-12-14 |
| CERVISTA HPV HR (P080014/S014) | Hologic, Inc. | 2012-12-14 |
| ARCHITECT CORE-M (P060035/S018) | Abbott Laboratories | 2012-12-14 |
| ARCHITECT HBSAG/CONFIRMATORY (P060007/S025) | Abbott Laboratories | 2012-12-14 |
| ARCHITECT CORE (P080023/S019) | Abbott Laboratories | 2012-12-14 |
| ARCHITECT ANTI-HCV (P050042/S021) | Abbott Laboratories, Inc. | 2012-12-14 |
| ARCHITECT HBSAG QUALITTATIVE/CONFIRMATORY (P110029/S010) | Abbott Laboratories | 2012-12-14 |
| ARCHITECT ANTI-HCV (P050042/S020) | Abbott Laboratories, Inc. | 2012-12-10 |
| ARCHITECT HBSAG/CONFIRMATORY (P060007/S024) | Abbott Laboratories | 2012-12-10 |
| ARCHITECT CORE-M (P060035/S017) | Abbott Laboratories | 2012-12-10 |
| ARCHITECT CORE (P080023/S018) | Abbott Laboratories | 2012-12-10 |
| ARCHITECT AUSAB (P050051/S018) | Abbott Laboratories, Inc. | 2012-12-10 |
| ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY (P110029/S009) | Abbott Laboratories | 2012-12-10 |
| AXSYM AUSAB (P060003/S012) | Abbott Laboratories, Inc. | 2012-12-05 |
| AXSYM HBSAG/HBSAG CONFIRMATORY (P050049/S011) | Abbott Laboratories, Inc. | 2012-12-05 |
| ARCHITECT HBSAG QUALITATIVE/HBSAG QUALITATIVE CONFIRMATORY (P110029/S008) | Abbott Laboratories | 2012-12-05 |
| ARCHITECT AUSAB (P050051/S017) | Abbott Laboratories, Inc. | 2012-12-05 |
| AXSYM ANTI-HCV (P970027/S018) | Abbott Laboratories | 2012-12-05 |
| ARCHITECT CORE-M (P060035/S016) | Abbott Laboratories | 2012-12-05 |
| AXSYM CORE-M 2.0 (P060009/S007) | Abbott Laboratories, Inc. | 2012-12-05 |
| ARCHITECT CORE (P080023/S017) | Abbott Laboratories | 2012-12-05 |
| AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST (P940034/S019) | Gen-Probe, Inc. | 2012-12-05 |
| ARCHITECT ANTI-HCV (P050042/S019) | Abbott Laboratories, Inc. | 2012-12-05 |
| AXSYM CORE 2.0 (P060012/S010) | Abbott Laboratories, Inc. | 2012-12-05 |