| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.0 (P000012/S035) | Roche Molecular Systems, Inc. | 2011-10-11 |
| ARCHITECT CORE-M (P060035/S010) | Abbott Laboratories | 2011-10-07 |
| AXSYM CORE (P060012/S008) | Abbott Laboratories, Inc. | 2011-10-07 |
| AXSYM ANTI-HCV (P970027/S015) | Abbott Laboratories | 2011-10-07 |
| ABBOTT AXSYM AUSAB (P060003/S010) | Abbott Laboratories, Inc. | 2011-10-03 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S021) | Roche Molecular Systems, Inc. | 2011-09-30 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S034) | Roche Molecular Systems, Inc. | 2011-09-29 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S016) | Ortho-Clinical Diagnostics | 2011-09-27 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S022) | Ortho-Clinical Diagnostics, Inc. | 2011-09-27 |
| ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON E170 IMMUNOASSAY ANALYZER (P090009/S003) | Roche Diagnostics Corp. | 2011-09-23 |
| ELECSYS ANTI-HBS IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBS (P010054/S014) | Roche Diagnostics Corp. | 2011-09-23 |
| ELECSYS ANTI-HBC IMMUNOASSAY ON THE MODULAR ANALYSTICS E170 IMMUNOASSAY ANALYZER (P100031/S003) | Roche Diagnostics Corp. | 2011-09-23 |
| ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 (P090007/S003) | Roche Diagnostics Corp. | 2011-09-23 |
| ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 (P090008/S003) | Roche Diagnostics Corp. | 2011-09-23 |
| ELECSYS HBSAG IMMUNOASSAY & CONFIRMATORY & PRECICONTROL HBSAG (P990012/S009) | Roche Diagnostics Corp. | 2011-09-23 |
| ELECSYS ANTI-HBC IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER (P100032/S003) | Roche Diagnostics Corp. | 2011-09-23 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S022) | Roche Molecular Systems, Inc. | 2011-09-22 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR (P000044/S027) | Ortho-Clinical Diagnostics, Inc. | 2011-09-16 |
| ETI-EBK PLUS KIT (P990043/S014) | DiaSorin, Inc. | 2011-09-16 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S020) | Ortho-Clinical Diagnostics, Inc. | 2011-09-15 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & 2000 HBSAG CONFIRMATORY (P010050/S014) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-09-13 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBS (P010052/S010) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-09-13 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC (P010053/S009) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-09-13 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC (P010051/S010) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-09-13 |
| ANTI-HBS IMMULITE ASSAY (P010052/S009) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-09-02 |
| ANTI-HBC IMMULITE ASSAY (P010051/S009) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-09-02 |
| ANTI-HBCM IMMULITE ASSAY (P010053/S008) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-09-02 |
| HBSAG IMMULITE ASSAY (P010050/S013) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-09-02 |
| HOME ACCESS HEPATITIS C CHECK TEST SYSTEM (P980046/S008) | Pwn Health Chicago, LLC | 2011-08-31 |
| QUANTIFERON-TB GOLD (P010033/S018) | Qiagen | 2011-08-23 |
| AMPLICOR HCV TEST (P000010/S019) | Roche Molecular Systems, Inc. | 2011-08-17 |
| AMPLICOR HCV TEST (P000010/S023) | Roche Molecular Systems, Inc. | 2011-08-09 |
| COBAS AMPLICOR HCV TEST (P000012/S032) | Roche Molecular Systems, Inc. | 2011-08-09 |
| ELECSYS ANTI-HBS IMMUNOASSAY (P010054/S015) | Roche Diagnostics Corp. | 2011-08-08 |
| BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (P970055/S011) | Diasorin | 2011-08-03 |
| CERVISTA HPV HR COMPONENTS (P080014/S009) | Hologic, Inc. | 2011-08-02 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR (P010021/S019) | Ortho-Clinical Diagnostics, Inc. | 2011-08-02 |
| CERVISTA HPV 16/18 (P080015/S005) | Hologic, Inc. | 2011-08-02 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S005) | OraSure Technologies, Inc. | 2011-07-27 |
| ELECSYS ANTI-HBC IMMUNOASSAY (P100031/S001) | Roche Diagnostics Corp. | 2011-07-22 |
| ELECSYS ANTI-HBC IMMUNOASSAY (P100032/S001) | Roche Diagnostics Corp. | 2011-07-22 |
| ARCHITECT AUSAB (P050051/S006) | Abbott Laboratories, Inc. | 2011-07-20 |
| ARCHITECT CORE (P080023/S003) | Abbott Laboratories | 2011-07-20 |
| ARCHITECT ANTI-HCV (P050042/S007) | Abbott Laboratories, Inc. | 2011-07-20 |
| ARCHITECT CORE-M (P060035/S003) | Abbott Laboratories | 2011-07-20 |
| ARCHITECT HBSAG/CONFIRMATORY (P060007/S005) | Abbott Laboratories | 2011-07-20 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS (P100001) | Ortho-Clinical Diagnostics | 2011-07-20 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S017) | Roche Molecular Systems, Inc. | 2011-07-07 |
| ABBOTT AXSYM HBSAG & HBSAG CONFIRMATORY (P050049/S007) | Abbott Laboratories, Inc. | 2011-07-01 |
| ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER (P100032) | Roche Diagnostics Corp. | 2011-06-27 |
| COBAS AMPLICOR HCV TEST/COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S027) | Roche Molecular Systems, Inc. | 2011-06-27 |
| ARCHITECT HBSAG/CONFIRMATORY (P060007/S015) | Abbott Laboratories | 2011-06-24 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S011) | Roche Molecular Systems, Inc. | 2011-06-24 |
| ARCHITECT CORE-M (P060035/S009) | Abbott Laboratories | 2011-06-24 |
| IMMULITE 2000 HBS AG CONFIRMATORY KIT (P010050/S011) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-06-24 |
| ARCHITECT AUSAB (P050051/S013) | Abbott Laboratories, Inc. | 2011-06-24 |
| ARCHITECT CORE (P080023/S009) | Abbott Laboratories | 2011-06-24 |
| ARCHITECT ANTI-HCV (P050042/S013) | Abbott Laboratories, Inc. | 2011-06-24 |
| CERVISTA HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR) (P080014/S008) | Hologic, Inc. | 2011-06-23 |
| CERVISTA HUMAN PAPILLOMA VIRUS (HPV) 16/18 (P080015/S004) | Hologic, Inc. | 2011-06-23 |
| AXSYM ANTI-HCV (P970027/S014) | Abbott Laboratories | 2011-06-22 |
| ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC (P100031) | Roche Diagnostics Corp. | 2011-06-22 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S023) | Ortho-Clinical Diagnostics, Inc. | 2011-06-14 |
| ABBOTT AXSYM AUSAB (P060003/S005) | Abbott Laboratories, Inc. | 2011-06-09 |
| ARCHITECT AUSAB (P050051/S012) | Abbott Laboratories, Inc. | 2011-06-01 |
| ARCHITECT CORE-M (P060035/S008) | Abbott Laboratories | 2011-06-01 |
| ARCHITECT HBSAG/CONFIMATORY (P060007/S014) | Abbott Laboratories | 2011-06-01 |
| ARCHITECT CORE (P080023/S008) | Abbott Laboratories | 2011-06-01 |
| ARCHITECT ANTI-HCV (P050042/S012) | Abbott Laboratories, Inc. | 2011-06-01 |
| QUANTIFERON-TB GOLD IN-TUBE (P010033/S017) | Qiagen | 2011-05-26 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S026) | Roche Molecular Systems, Inc. | 2011-05-24 |
| ARCHITECT CORE (P080023/S005) | Abbott Laboratories | 2011-05-20 |
| AXSYM AUSAB (P060003/S007) | Abbott Laboratories, Inc. | 2011-05-20 |
| AXSYM HBSAG/CONFIRMATORY (P050049/S005) | Abbott Laboratories, Inc. | 2011-05-20 |
| AXSYM ANTI-HCV (P970027/S011) | Abbott Laboratories | 2011-05-20 |
| ARCHITECT CORE-M (P060035/S005) | Abbott Laboratories | 2011-05-20 |
| AXSYM CORE-M (P060009/S003) | Abbott Laboratories, Inc. | 2011-05-20 |
| AXSYM CORE (P060012/S005) | Abbott Laboratories, Inc. | 2011-05-20 |
| ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV (P100017) | Abbott Molecular, Inc. | 2011-05-17 |
| ARCHITECT CORE (P080023/S007) | Abbott Laboratories | 2011-05-13 |
| ARCHITECT CORE-M (P060035/S007) | Abbott Laboratories | 2011-05-13 |
| ABBOTT AXSYM AUSAB (P060003/S009) | Abbott Laboratories, Inc. | 2011-05-13 |
| ARCHITECT ANTI-HCV (P050042/S011) | Abbott Laboratories, Inc. | 2011-05-13 |
| ARCHITECT AUSAB (P050051/S011) | Abbott Laboratories, Inc. | 2011-05-13 |
| ARCHITECT HBSAG/CONFIRMATORY (P060007/S013) | Abbott Laboratories | 2011-05-13 |
| ANTI-HBC (P010051/S008) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-05-12 |
| ANTI-HBS (P010052/S008) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-05-12 |
| HBSAG (P010050/S012) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-05-12 |
| ANTI-HBC IGM (P010053/S007) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-05-12 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS HBSAG REAGENT PACK & CALIBRATOR (P000044/S026) | Ortho-Clinical Diagnostics, Inc. | 2011-05-11 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS (P090028) | Ortho-Clinical Diagnostics, Inc. | 2011-05-11 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S015) | Ortho-Clinical Diagnostics | 2011-05-11 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S018) | Roche Molecular Systems, Inc. | 2011-05-05 |
| T-SPOT TB TEST (P070006/S005) | Oxford Immunotec, Ltd. | 2011-05-04 |
| ELECSYS ANTI-HCV IMMUNOASSAY (P090007/S002) | Roche Diagnostics Corp. | 2011-05-04 |
| ELECSYS ANTI-HBS IMMUNOASSAY (P010054/S013) | Roche Diagnostics Corp. | 2011-05-04 |
| ELECSYS ANTI-HCV IMMUNOASSAY (P090009/S002) | Roche Diagnostics Corp. | 2011-05-04 |
| ELECSYS ANTI-HCV IMMUNOASSAY (P090008/S002) | Roche Diagnostics Corp. | 2011-05-04 |
| ELECSYS HBSAG IMMUNOASSAY (P990012/S008) | Roche Diagnostics Corp. | 2011-05-04 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S006) | OraSure Technologies, Inc. | 2011-05-04 |